INSTRUMENT OF GIFT

Henry R. Winkler Center for the History of the Health Professions University of Cincinnati Libraries

1, Henry J, HeimlJch, MD_and I, Patrick Ward (the representative of the Deaconess Association Foundation), (hereinafter referred to as the "Donors"), sole and absolute owners of these materials, do hereby transfer, give, grant, and assign to the University of Cincinnati (hereinafter the "University") and its successors and assigns the materials described as follows: Awards, files, books, photographs correspondence, reports, and other written documents in paper and electronic formats currently housed in the Hefmlich Institute and elsewhere in the personal collection of Dr. Henry J. Heimlich. Copyright Donors transfer all copyrights that Donors hold in the materials to the University. Transfer Donors intend to physically convey the materials to the University by means mutually satisfactory to the Donors and the University on or before March 1,2011. Donors recognize that any materials that the University determines to be inappropriate for retention in the collection will be disposed of in accordance with standard Winkler Center for the History of the Health Professions procedures. Research Access Donors recognize that the University will make these materials open to qualified researchers pursuant to the access policies of the Winkler Center for the History of the Health Professions. Future Transfers The terms of this Instrument of Gift will cover all future transfer of materials by the Donors unless a specific addendum accompanies a particular transfer of materials. In full accord with the provisions of this Instrument of Gift, I hereunto set my hand.

Donor Signature:

Printed Name: Hem Donor Signature: ^ \ ^ / A \ ^ / X

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^

Printed Name: Patrick Ward (Representative offePeaconess Association Foundation

Da,c:

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DIVIDER

dh I DEACONESS HOSPITAL
| 311 Straight Street Cincinnati, Ohio 45219 (513) 559-2100
July 6, 1999

Henry Heimlich, M.D. The Heimlich Institute 415 Straight Street Cincinnati, OH 45219

Dear Dr. Heimlich, I am writing on behalf of the Deaconess Institutional Review Board. I understand from conversation with Charles McDowell that there is some doubt in your mind as to the position of the IRB regarding your proposal to the IRB outlining the use of the Heimlich Maneuver in the treatment of asthma in the emergency room. At the time that you and Eric Spletzer attended the IRB meeting, members discussed their concerns relative to obtaining informed consent from patients in the emergency room seeking treatment for respiratory distress. Members also recommended that this research might be better accomplished by gaining the support and cooperation of primary care physicians who have known patients with asthma and who could assist with enrolling patients at a time other that an acute emergency. Based on the above informed consent issue and the fact that our emergency department sees a very limited number of children, smaller than the pediatric sample desired in your study, the members of the IRB do not think it would be desirable to proceed with this research in the Deaconess Emergency Room. I believed that you understood the concerns of the IRB members and apologize for any confusion. Please feel free to call me at 559-2265 if questions remain.

Sincerely,

$b*Mdm~
Nancy Wilson Director, Quality Resource Management

INSTITUTE

ITHEI HEIMUCH

311 STRAIGHT STREET CINCINNATI OHIO 45219 513-559-2391 FAX 513-559-2403 heimlich@iglou.com

July 7, 1999

Ms. Nancy Wilson Director, Quality Resource Management Deaconess Hospital 311 Straight Street Cincinnati, OH 45219 Dear Ms. Wilson: Thank you for your letter of July 6. The Heimlich Institute is receiving an IRB from a national medical organization through which clinical trials will be carried out elsewhere. Deaconess Emergerxy Room physicians are aware of the scientific basis for using the Heimlich maneuver to save the lives of the 14 asthmatics who die every day during an acute attack. It is hoped that should their usual treatment for such a condition be ineffective, they will attempt to save the victim's life by using the Maneuver rather than letting the patient succumb.

Henry J. He ilich, M.D., ScD. President

cc: Charles McDowell

Benefiting Humanity Through Health and Peace

Affiliated with The Deaconess Associationss,nc.

DIVIDER

Original Message From: "Henry J. Heimlich" <heimlich@iglou.com> To: <Charles@Piercel.net> Sent: Tuesday, 11 December, 2001 1:41 PM Subject: Asthma protocol & informed consent Dear Dr. Pierce, It was a pleasure meeting you to day. I look forward to working with you. Attached are the protocol and informed consent in WordPerfect and MSWord formats. If you have any problem opening these, please let me know. Eric G. Spletzer, PhD Heimlich Institute

_ Name: rlMM^rotocoi-Draft.doc IL RjHMM Protocol -Draft.rinr. Type: Microsoft Word Document (application/msword): ! Encoding: base64

; :2

12/17/01 8:40 AM

November 1998

ASTHMA PROTOCOL BACKGROUND

The Heimlich maneuver has been successfully used in treating acute asthmatic attacks. At a conference five years ago. a woman raised her band related an unexpected incident. She told of how her sister, an asthmatic, suffered a sudden attack. The sister couldn't breath and began turning blue. The woman performed the only emergency measure she knew - the Heimlich maneuver. As soon as the Heimlich maneuver had been performed, the sister took a deep breath and recovered. Shortly after that, we received a letter from the mother of a four-year-old girl describing the onset of an asthma attack. In this case, the attack was so severe that the child could not even inhale her medication. The mother was about to rush the child to the emergency room, but decided there wasn't time. She performed the Maneuver and the child began breathing normally. Because of anecdotal reports such as these, use of the Heimlich maneuver for asthma should be studied. According to the National Institute of Allergy and Infectious Diseases of the National Institutes of Health, more than 15 million Americans suffer from asthma. Fourteen .Americans, many of them children, die every day during acute asthma attacks. In a year, in one New York City hospital, 22 children died of acute asthma attacks in the emergency room. Asthma attacks, which consist of prolonged spells of wheezing and shortness of breath that can be fatal, occur when muscles surrounding the airways contract, narrowing tiie air passages, the linings of which are chronically swollen and inflamed. Mucus fills the airway and acts as a valve, i.e.. when the asthmatic breathes in, the airway opens up and air slides around mucous plugs. On exhaling, mucous plugs clog narrowed airways and air cannot get out. Trapped stale air distends the lungs, making both inhalation and exhalation difficult. Pushing up on the diaphragm with the Heimlich Maneuver compresses the lungs, expelling trapped air and mucous plugs, thus clearing the airway and ending the asthma attack. Just as choking victims can perform the Heimlich Maneuver on themselves, asthma patients can treat their own attacks or have someone else perform the maneuver on them. The maneuver should be done more gently on asthma patients, particularly children, than on choking or drowning victims. Some physicians have expressed concern because they mistakenly assume the Heimlich maneuver functions by increasing air pressure within the lungs. That is incorrect. Extensive studies show there is minimal intrapulmonary pressure increase. The Heimlich maneuver elevates the diaphragm, diminishing the volume of the pleural (chest) cavity which compresses the entire lung evenly, resulting in a flow of air out of the alveoli through the tracheobronchial tree towards the mouth. The air flow transmits kinetic energy to foreign bodies (food, water, mucus), dislodging the obstruction. This same free flow of air originating from the alveoli, passes through the bronchi, and carries the mucus toward the trachea, clearing the airway.

PURPOSE To determine the role of the Heimlich Maneuver in treating asthma. 1. Use of the Heimlich Maneuver to overcome an acute asthmatic attack. 2. Use of the Heimlich Maneuver prophylacticaUy to prevent asthma attacks. 3. To determine whether use of the Heimlich Maneuver will diminish or eliminate the need for medication in asthma. 4. Teaching physicians to perform the Heimlich Maneuver for asthma on patients. 5. Teaching asthmatics to perform the Heimlich Maneuver on themselves. Basis for Use of the Heimlich Maneuver in Asthma 1. Compressing the lungs expels air trapped distal to mucus and bronchial constriction site (emergency use). 2. The removal of mucous plugs and mucus (emergency and prophylactic use). 3. Expulsion of pollen granules or other irritants (prophylactic use predominantly; may have some utility in emergency situations). 4. Timing of the Heimlich maneuver for maximum prophylactic effect is uncertain; several possible regimens are suggested to indicate the effects of relative time and number for optimal results. PATIENT SELECTION CRITERIA 1. Patient must not have continuous or intractable asthma. 2. Patient must have at least a 6-month history of asthma to establish baseline condition.

The Heimlich Maneuver when applied for asthma is different from its application for choking. In asthma, the Maneuver should be applied with steady even pressure, rather than vigorous rapid pressure.

The Heimlich Institute Heimlich Maneuver for Asthma Protocol for Selection and Assessment I. Patient Selection A. Age Children (4-10 yr), Adolescents (11-16 yr), Young adults (17-25), Adults (2550), Advanced Age (51+) B. Gender Either C. Asthma Severity Low (1 attack/mo-1 attack/wk), Moderate (2-3 attacks/wk), Severe (4-7 attacks/wk); not continuous or intractable asthma. Baseline period of 6 months. D. Absence of other pulmonary conditions (i.e., history of smoking, chronic bronchitis, emphysema, COPD, cystic fibrosis, etc.) E. Absence of contraindications (i.e., recent surgery [particularly abdominal surgery], ulcers, hernias [particularly diaphragmatic hernias], artificial heart valves, pre existing aneurysm, pregnancy F. Random placement of patients into control and test groups II. Pretesting A. General Physical - Good general health, no other complicating conditions B. Pulmonary function tests PEFR, FVC, FEV1; FEF2575 1) Consistent testing protocol especially with regards to time of day and time relative to ingestion of medicine 2) In the event that FVC, FEV and/or FEF2..75 tests are unavailable because of lack of equipment or cost, the use PEFR solely is acceptable C. Current medication regimen recorded III. Trial Period During the trial study, treatment of asthma shall follow normal course with the addition of the Heimlich maneuver (HM) to the treatment protocol (i.e., in acute attacks, standard emergency drug therapy will be administered with the HM given as soon as possible to supplement treatment). All changes are to be noted by participating physicians and patients. The HM will not be used on pregnant study patients. A. Heimlich maneuver treatment regimen 1) Emergency - Used during attacks only 2) Prophylactic 1 - HM performed prophylactically in the evening, before bed, and used during attacks 3) Prophylactic 2 - HM performed prophylacticak> in the morning, upon arising, and used during attacks 4) Prophylactic 3 - HM performed prophylactically in the morning and evening, and used during attacks B. Record all changes in medication regimen (i.e., reduced levels of drugs to relieve acute attacks, reduction of normal daily drug dosage as a result of testing) C. Record all observations concerning treatment of asthma attacks with HM (i.e., faster

relief, increased mucus expulsion, etc.) D. Participant log note changes in number, duration or severity of attacks; changes in medication usage; general feelings regarding effects of asthma IV. Post Trial Testing (6 mo.) A. General Physical B. Pulmonary function tests PEFR, FVC, FEV . FEF25.-5 immediately after trial period and at end of six months 1) Consistent testing protocol especially with regards to time of day and time relative to ingestion of medicine 2) In the event that FVC, FEV,. and/or FEF 25 ^ tests are unavailable because of lack of equipment or cost, the use PEER solely is acceptable C. Changes in medication regimen recorded V. Analysis A. Longitudinal assay of pulmonary function tests B. Longitudinal assay of medication requirements C. Longitudinal assay of number and duration of asthma attacks VI. Outcomes A. Effective emergency relief of asthma B. Effective prophylactic relief of asthma temporary C. Effective prophylactic relief of asthma permanent D. No prophylactic effect E. No emergency relief

Heimlich Maneuver for Asthma Physician Record - For Research Only (For initial anu Follow-up Patient Reports - page 1) Name of Patient: Name of Physician: Weight: Age: Sex- M F Patient Classification: Control Group Emergency Prophylactic 1 Prophylactic 2 Prophylactic 3 General Condition of Patient: Date of Examination:

Number of attacks per week: Severity of asthma:

Severity of attacks:

Current Physical Impairment Due to Asthma: None / Describe

Current Asthma Medication Regimen:

Pulmonary Testing: PEFR FVC FEV, FEV^FVC FEF25.75

Heimlich Maneuver for Asthma Physician Record - For Research Only (Patient Follow-up Reports - page 2)

Patient Name: Has need for medication: Increased Decreased D Remained unchanged Number of attacks per week: The number of attacks per week have: Increased Decreased Remained unchanged Severity of attacks has: Increased Decreased D Remained unchanged Patient feels the severity of their asthma attacks has: Increased secreased D Remained unchanged Current Physical Impairment Due to Asthma: None / Describe Severity of attacks:

Patient feels their asthmatic condition has: Improved Worsened Remained unchanged

The Self-Administered Heimlich Maneuver (Should be practiced under physician's observation to ensure technique is correctly understood by participant) Method (Refer to poster): Make a fist. Place the thumb side of the fist on the midline of your abdomen, halfway between bottom tip of the sternum and your navel. (Never press against the ribs.) Grasp your fist with your other hand. Breathe normally. Press the fist into your abdomen with quick upward pressure. Subject should experience exhalation of air and may cough up mucus. Repeat process twice more. Should abdominal discomfort occur and persist, see a physician immediately. Contraindications: Recent surgery (particularly abdominal surgery), ulcers, hernias (particularly diaphragmatic hernias), artificial heart valves, ongoing abdominal discomfort (see physician), pre-existing aneurysm.

EXPLANATION OF COLUMN HEADINGS IN LOG Severity of the attack is determined by use of a modified (for self-monitoring) version of the Asthma Severity Scale system. Four parameters are used and rated on a scale of 0-3. Factors Wheezing: None - 0; felt during exhalation - 11 felt during both inhalation aad exhalation 2; audible - 3 Accessory Muscle Use (use of other than normal muscles to aid breathing): None - 0; otherwise 1 (minimal effort) - 3 (maximum effort) Pulse Rate: 80 beats per minute or less - 0; 81-110 beats per minute - 11 ;11-140 beats per minute - 2; more than 140 beats per minute - 3 Cyanosis: No discoloration - 0; skin reddened - 11 ;kin slightly bluish - 2; lips snd skin nlue -3

Medication: What medication was used? Dose: How much was used? HM?: Was the Heimlich maneuver performed? (Yes or No; if "Yes" indicate number of HM's performed) Effect & Observations: What effect if any did the Heimlich maneuver have on the asthma attack? How did you feel after using it? Was any mucus expelled by the Heimlich maneuver? What changes in wheezing, breathing, pulse and/or skin and lip color were noticed?

Heimlich Maneuver for Asthma Patient Log - For Research Only Name of Patient: mm/yy: Drugs and Dosage (note any changes made during the monlh): Name of Physician: USUAL PREVENTIVE MEDICATION

Heimlich Maneuver for Asthma Patient Log - For Research Only Name of Patient: mm/yy: Date AM 1 PM AM 2 PM AM 3 PM AM 4 PM AM 5 PM AM 6 PM AM 7 Time W AMU PR C EMERGENCY RELIEF Medication Dose HM? Effect & Observations Name of Physician: PREVENTIVE Time HM?

PM

INFORMED CONSENT TITLE OF RESEARCH STUDY: The HEIMLICH MANEUVER for ASTHMA INTRODUCTION
The increasing incidence and fatality rate caused by acute asthma, despite the development of new drug therapies, signify a major health threat. Since the problem in an ac:te asthma attack is obstruction of the bronchioles by mucus, investigation of the Heimlich maneuver, which has been prover, to relieve airway obstruction caused by foreign bodies or fluids, is warranted for relief of asthma symptoms.

PURPOSE OF STUDY
The purpose of this study is to assess the effectiveness and safety of the Heimlich maneuver (HM) for the treatment of asthma. It is anticipated that the HM will rapidly relieve the symptoms of acute asthma attacks. Asthma relief may demonstrate itself by reduced difficulties in breathing and be measured by changes in pulmonary function tests.

DURATION OF STUDY
The duration of the study will be unlimited. Visits to your participating physician for appropriate follow-up are required.

STUDY PROCEDURE
You will undergo or submit to a medical history examination at study entry. and physical

You may withdraw from the study at any time without jeopardizing your future medical care or possible involvement in subsequent clinical studies. Your participation may be terminated by the researchers under these circumstances:

1.

Deteriorating health or other conditions that might make continued participation detrimental to your health. Failure to follow treatment protocol. Decision by the medical grounds. investigators to stop the study on

2. 3.

RISKS AND DISCOMFORTS

You understand and acknowledge that HM in the treatment of asthma will only be used in for evaluation of treatment of symptoms from asthma. There may be discomfort from the HM. Such discomfort may include abdominal pain. You further understand that there is a risk of adverse side effects or complications as a result of receiving treatment. Such adverse side effects or complications may include, but are not necessarily limited to internal injuries.

POTENTIAL BENEFITS
By signing this document, you understand that the research investigators do not guarantee, represent, or warrant that treatment with the Heimlich Maneuver may stop or retard the progress or recurrence of asthma. The investigators cannot promise that your participation in this research study will guarantee any direct or immediate benefit to you. However, the Heimlich maneuver may benefit you by relieving the mucus obstruction of the airway which causes an asthmatic attack. The knowledge gained from this study may be of benefit to you and others in the future.

OTHER INFORMATION
In case of any medical problems, side effects or other reactions the patient should contact his or her primary care physician for treatment at the following number: If it is believed the problem is related to the study, have your participating physician contact the study coordinator at:
( )

You realize that the administration of the Heimlich maneuver is being done as a pilot study for medical research and there is no commitment by the Principal investigators to provide access to this modality in the future.

POLICY REGARDING PREGNANCY

Pregnant women will not be treated with the Heimlich maneuver during the course of this study.

CONFIDENTIALITY
You understand that all information will be held confidential and will not be released without your written permission. Furthermore, you understand that your records and results will not be identified in any publications as pertaining to you specifically. You will be identified only by a code number for the purposes of the study, known only to study personnel. You understand that you will also be giving consent for the Principle Investigator to review your medical records as may be necessary for the purpose of this study.

CONSENT
You understand that you have the right to request the Principle Investigator and/or your physician to answer any and all questions you might have concerning this therapy at any time prior to or during the course of the study. You understand that you have the absolute right to terminate your participation in this study at any point during its course. You hereby agree to hold harmless the Heimlich Institute, Dr. Henry Heimlich, Dr. XXXXXX and all other health care providers involved in any way in this study. You understand that the use of Heimlich Maneuver for asthma is on an experimental basis, and that this research treatment has been approved by the YYYYY. You voluntarily accept all risks associated with the use of the method, known or unknown. You understand that this agreement is binding on you, your estate, your heirs and assignees, and extends to all liability of any nature whatsoever, including any claim for negligence or failure to warn. You hereby bind yourself, your estate, your heirs and assigns, and any other

person or entity claiming to act on your behalf or on the behalf of your estate, your heirs or assigns, not to make claim against any person or entity whatsoever, for anything of value, arising out of the use of this method. Your signature indicates that you have read and understand this consent form. You have decided to participate in this research study. You have received a copy of this informed consent. You understand the nature of the study, the procedures, the benefits, and the risks. I have had the opportunity to ask questions and have all responses explained to me by the Principal Investigator in a language I understand. I freely agree to enroll in this study having read, in detail, this Informed Consent Form.

Patient or Legal Guardian (Signature)

Date

Address

Witness (Signature) (Next of Kin)

Date

Witness (Signature)

Date

I certify that I have explained fully to the above patient the nature and purpose, the potential benefit and possible risk of the indicated study.

Physician (Signature)

Date

If signed by other than the patient, please explain below:

**sthma protocol & informed consent

Subject: Re: Asthma protocol & informed consent Date: Sun, 16 Dec 2001 21:49:22-0500 From: "Charles H. Pierce" <charles@piercel.net> To: "Henry J. Heimlich" <heimlich@igiou.com>
Henry & Eric, Attached is a first draft - first go through - first try. I stress this as these always take a lot of thought and are changed often till we get it to say what we want it to say and what we are doing and measuring is clear. The only concerns I have are in the 4 different treatment (with the HMM) regimens as to have this meet any statistical relevance would need at least 6-10 per group. I propose that we think about maybe two regimens. The attached is the general format of an industry sponsored protocol which, at least will give some comfort to whichever IRB we use as it will look familiar in general terms. We can further tune it at a next meeting to take it to the next level. I have made a few comments in blue which you may of may not be able to print as blue. This would be an absolutely ideal study for electronic diaries as what happens outside of the visits is by far the most important data and to get this accurately is essential in this study - in my view. You may note that I was very clear that this is a "MODIFIED" HM, This is really important as the public's perception of the HM is not what we are intending to be used and we must differentiate this study from the standard use or perception of use. We just cannot risk an IRB turning this down because of their perceptions. Let me know when it is convenient for me to meet with you both again. Best regards, Charles. Charles H. Pierce, MSc, MD, PhD 5563 Regimental Place Cincinnati, Ohio 45239 Phone - 513 681 4084 Fax - 513 681 4094 Email address: Charles@Piercel.net Personal Web site: http://Dr.Piercel.net Consultant Web site: www.pmci.org

r
DRAFT

A Prospective Historic Controlled Study on the Utility of Using The Heimlich Maneuver for Asthma" (HMM) as an adjunct In the Management of Mild to Moderate Asthma in Children and Young Adults

Protocol XXX

This document is a confidential communication of the Department of Pediatrics of the Queen Elizabeth Hospital, Bridgetown Barbados, Wl. The information contained herein will not be disclosed to others without written authority of the Department of Pediatrics except for the Institutional Review Board

Anne St.John, MD Chair, Department of Pediatrics Queen Elizabeth Hospitaal Bridgetown, Barbados, West Indies

12 February 2002 (This date changes with each draft and improvement)

CONFIDENTIAL CONRDENTIAL 1. Introduction The problem of asthma on the island of Barbados is one of major proportions costing the Health Service an inordinate amount of money. The yearly average is more than 12:000 Emergency Room visits to treat patients in an asthmatic crisis and an eye-popping and rather alarming 12 (one per month) deaths. This figure is staggeringly high compared to that of North America especially when "emergency" treatment (via simple aerosol) or the "Heimlich Maneuver for Asthma" could and should be available or used either at home for the severe asthmatic or at local community clinics. Asthma is a worldwide problem of increasingly importance but nowhere is it so prevalent and deadly as in the island nation of Barbados. These deaths should be totally preventable which is the reason for this project. Asthma is unique as a medical condition, in that it is both an episodic illness and a chronic one requiring long- term care and stabilization. During the episodic asthmatic attacks patients experience airway hunger, anxiety and are desperate for immediate relief. They then seek immediate medical care at the Asthma Bay of the Queen Elizabeth Hospital. This facility is open 24 hours a day and patients are allowed to enter the Bay once they inform the triage nurse of their problem. It is available free of cost to all citizens of Barbados. Over the years, however, there has been a tremendous rise in the number of patients seeking care at this Asthma Bay. In 1978 there were 2,642 patients and this rose to 9,781 in 1998. This four-fold rise needs not only an explanation but a management plan that will reduce a number of visits. In trying to seek why certain patients are more susceptible to asthma than others, Barbados has an ongoing collaborative study on the Genetics of Asthma with Johns Hopkins Allergy and Asthma Institute in the United States( Naidu, Barnes et al). It is expected that this study will assist in identifying genes that are specifically linked with asthma. At the same time, however, a better system of asthma care has to be offered to the national population suffering from this condition. A recent survey (Salazar, Naidu) done in the Asthma Bay showed that after an acute attack and treatment in the Asthma Bay only 38% of patients reported to have follow up treatment by their primary care physician. Just as striking from the survey was that 20% of these patients had two (2) attacks within the last 3 months, 17% three (3) attacks, 8% four (4) attacks, 7% five (5) attacks and 5% greater than six (6) attacks within the last 3 months. This should be no surprise with the current nadequate follow up care mentioned above. Asthma attacks, which consist of prolonged spells of dyspnea and shortness of breath that can be fatal, occur when muscles surrounding the airways contract, narrowing the air passages, the linings of which are chronically swollen and inflamed.1 Mucus fills the airway and acts as a valve, i.e., when the asthmatic breathes in, the airway opens up and air slides around mucous plugs. On exhaling,

~ - : c . ; : _ : ; : zz -a--~.'.ad airways and air cannot get out. Traoped air distends the lungs. making both inhalation and exhalation difficult. The term attack" refers, in this document, to a rather sudden increase in the symptoms we know as "Asthma". The "Heirnlich Maneuver for Asthma" consists of applying pressure to the upper abdomen, v.h ch has the effect of pressing the diaphragm upward. The upward movement of the diaphragm diminishes the volume of the chest cavity, thereby compressing the lungs uniformly, resulting in a flow of air out of the alveoli through the tracheobronchial tree toward the mouth. The airflow transmits kinetic energy to foreign substances, solid or liquid (food, water, mucus), dislodging the obstruction.2 Tests on ten volunteers demonstrated the Heirnlich maneuver expels a volume of 940 cc (0.94 L) of air from the lungs in approximately 1/4 of a second. The average flow rate is 205 liters per minute.3 This airflow was considered to be sufficient to carry foreign substances out of the airway, and this has proven to be accurate. Similar application of Heirnlich maneuver to drowning victims causes a flow of water from the lungs, which gushes out of the mouth. The physical principle that enables the Maneuver to expel foreign substances from the airway is energy, not pressure. Extensive studies show there is minimal intrapulmonary pressure increase. Kinetic energy of the airflow, the energy of motion, is transmitted to a foreign substance ejecting it from the airway.4 Kinetic energy is defined as the energy of a body or system with respect to the motion of the body or of the particles in the system. Airflow from the lungs to the mouth, as created by compression of the lungs, is a form of kinetic energy. The kinetic energy provided by airflow is equally effective whether the foreign substance is large enough to obstruct the airway or is a small object or fluid such as water or mucous. Anecdotal reports of Heirnlich maneuvers having a beneficial effect in asthma have appeared in recent years.5 Asthmatics report acute attacks stop immediately after the Heirnlich maneuver is used. The victim is reportedly able to breathe normally. When the Heirnlich maneuver is used prophylactically, there is a reported reduction in the number of attacks, and a general improvement including a lessening need for medications. As a working hypothesis, these observations are explainable by considering mucous, which prevent exhalation in an asthma attack, to be analogous to foreign bodies blocking small airways. Application of the Heirnlich maneuver to an asthmatic expels trapped air, which generates airflow that expels the mucus, allowing the victim to breathe. Mucous plugs are semi-liquid, smaller and lighter than a food object, which causes choking. It is postulated, therefore, that the "Heirnlich Maneuver for Asthma" (HMM), performed in a slow and steady manner, will clear the airway and end the asthma attack. In 1985, Dr. C. Everett Koop, then Surgeon General of the United States, advised, 'The Heirnlich Maneuver is safe, effective, and easily mastered by the average person. It can be performed on children and even on one's self."6 Asthma patients can, therefore, treat their own attacks or have someone else perform the HMM on

MM T-e -aneuver is to be done more gently en as:^ma patients, particularly __ ;en -.an - on choking3r drowning victims. ~ : ;e:=rmile whether the "Heimlich Maneuver for Asthma ;: (HMM) has a significant andor lasting effect on asthma requires a careful prospective study. The modrfication of the universally accepted Heimlich maneuver to be used in the present study is that pressing on the upper abdomen be done in a slow steady manner,

2. Study Objective / Significance To determine the role of the "Heimlich Maneuver for Asthma' (HMM), which is a modification of the usual maneuver only in being done with less vigor, in reducing the frequency of attacks and reducing the requirement for rescue medications in Mild Persistent and Moderate asthma by the following: 2.1 2.2 2.3 2.4 Use of the HMM to relieve the symptoms of an acute asthmatic attack. Use of the HMM prophylactically to reduce the frequency of asthma attacks . To assess the change in the patient's physician use of medications following regular HMM use. To assess the ease of teaching asthmatics to use the HMM on themselves and/or the ease of teaching parents/guardians in the use of the HMM

3. Summary of Study Design / Research Plan 3.1 Overview: 3.1.1 Referred patients will be assessed as to the severity of their symptoms of asthma and the number of times in the prior 6 months that they have had what they call an "attack" of their asthma The patient is then to be screened to insure that their history and present condition comply with the Inclusion / Exclusion criteria established Where applicable, meaning that the patient has the psychomotor skills and can be taught the procedure, a pulmonary function test will be performed using the KoKo spirometer. Each patient will also be instructed regarding to completion of the diary and the performance of peak flows with the provided peak flow meters Each patient and the patients parents or guardian, when applicable, will be taught how and when to perform the "Heimlich Maneuver for Asthma" (HMM) so that it is clear that this procedure can be done in a correct manner. Each patient will be given a diary and instructions as to how it is to be completed and the reasoning behind the questions asked. The patient will be encouraged to share this with her/his primary care giver. Each patient will be asked to perform a Peak flow determination before and after a HMM twice a week on non-consecutive days. It will be recommended that at least one of these be an early morning event. The patient will be instructed to follow the Asthma Action Plan recommended by her/his personal physician without delay but with the following modifications: When feasible, perform (or have performed) the HMM when an "attack" or worsening of symptoms is developing and recording this in the diary.

3.1.2 3.1.3

3.1.4

3.1.5

3.1.6

3.1.7

When the inhaler medication is prescribed "prn" or as "rescue therapy" and is needed, the patient or parent is asked to perform the HMM first with a PFR before and after if this can be done.

3.2

Flow sheet of study:

Screening M1 M2 M3 M4 M6 M8 M10 M12 Final*

Event
Informed Consent >clusion Exclusion criteria -s:ory demographics Complete physical exam pjlmonary Function Testing ' -eak Flow Rate (PEFR) z Dary training/Evaluation Clinical severity score J Safety Labs (Chem.CBC, UA) Adverse Events

X X X X
X1

X X X X X X X X X X X X X
X X

x^ x x3
X X

X X
X X

X X
X

X X X

X X X X

X X X X X

X X X X X X

* The "final visit" will be within 1 month of the final visit ' Pulmonary function will be performed on patients demonstrating the psychomotor skills required to perform the test correctly. 2 Peak flow rates (PEFR) will be determined at the study visits as demonstration that the patient knows and is comfortable with the procedure 3 The clinical severity score will be determined using the analog scales as per appendix II

3.3

Questions to be answered: 3.3.1 3.3.2 3.3.3 Is HMM an effective procedure for the emergency relief of the symptoms of an attack (acute exacerbation) of the symptoms of asthma? Is HMM an effective temporary measure for the relief of the symptoms and improvement in pulmonary function (PEFR) in patients with asthma? Does HMM reduce the number of acute attacks of asthma from that which the patient had experienced in the 6 months prior to the study and in the first two study visits? Does HMM reduce the reliance on regular or rescue medications? Does HMM reduce the need for prn medications? Does HMM enable the patient's physician to reduce the medical regimen? Does the use of HMM reduce the number of missed school days? Does the use of HMM reduce the number of ED visits

3.3.4 3.3.5 3.3.6 3.3.7 3.3.8 4.

Investigator and Facilities 4.1 Principal Investigator: Anne St. John, MD Chair, Department of Pediatrics College of Medicine of the Univ of the Wl Queen Elizabeth Hospital Bridgetown, Barbados

5. Subject Selection 5.1 Patients 30 patients who meet the criteria of mild persistent up to Severe Asthma and who voluntarily consent or assent (with parental consent) to the therapy will be used in this study Inclusion Criteria 5.2.1 Patients with a minimum of a six month history of asthma requiring regular medical therapy of any type Diagnosis of Mild Persistent asthma to Severe asthma according to the accepted criteria for this diagnosis (Appendix II) Patients greater than 5 years of age but less that 16 years of age of either sex In general good health except for the diagnosis of bronchial asthma. Have the psychomotor skills to learn and perform pulmonary function testing and/or peak flow rate measurements. Willing to keep a diary of medication use and PEFR determinations as recommended. Have no medically or clinically significant illness of the lungs or abdominal organs which in the view of the Principal Investigator might place the patient at any risk Patients who voluntarily assent to be on this study and whose parents will consent for their child to be on this study

5.2

5.2.2

5.2.3

5.2.4 5.2.5

5.2.6

5.2.7

5.2.8

5.3

Exclusion Criteria 5.3.1 History of clinically significant renal, hepatic, endocrine, oncologic, cardiovascular disease, or any other condition, which in the opinion of the Investigator, would jeopardize the safety of the patient or impact on the validity of the study results History of severe, continuous or intractable asthma History of smoking, Chronic bronchitis, emphysema or Cystic Fibrosis or any other pulmonary disease Recent surgery especially abdominal and thoracic surgery History of conditions where the HMM is contraindicated such as ulcers, abdominal hernias, diaphragmatic hernias, artificial heart valves, abdominal aneurysm and pregnancy. Unable or unwilling to give voluntary informed consent / assent or whose parents do not freely consent for their child to participate in this study.

5.3.2 5.3.3

5.3.4 5.3.5

5.3.6

&

= : : : - - : ;-:cedures " " = - - : i = - . s s ; ;a:=- or her/his designee will assess the following screening procedures a" :-= : ~5 : ' sree~ "g 6.1 Medical History A complex medical history, including a detailed list of medications taken (Drug dose, frequency of use, start and stop date) for all medications taken since the diagnosis of asthma was made. In addition, other prescription medication used in the month prior to the start of the study. For females of child bearing potential, the b^rth control methods used will be assessed. The documentation of a minimum of a six month history of asthma requiring the use of asthma medications prescribed on a regular or prn basis and used appropriately by the patient will be determined prior to proceeding to the next step. 6.2 Physical Examination 6.2.1 6.2.2 Height (in inches) and weight (in pounds). Vital signs while seated (respiratory rate, heart rate, blood pressure and temperature). Pulmonary function tests including FVC, FEV,, FEF 25-75, and the darious calculations made from these tests to be done on patients posing the psychomotor skills required for a standard PFT. Peak Flow rate testing (PEFR) using a Wrights Flowmeter plus PEFR using the device the patient will use while ambulatory

6.2.3

6.2.4

6.3

Clinical Laboratory tests: Results of laboratory tests are to be assessed at the investigators option and those beyond the reference ranges accepted for the study only if the Investigator determines that there is no risk to the patient should they have theHMM procedure done as per the protocol. 6.3.1 Hematology: Hemoglobin, Hematocrit, WBC, differential eosinophil count, RBC, platelet count including an

6.3.2

Serum Chemistry: Alkaline phosphatase, ALT, AST, LDH, Total bilirubin, Urea nitrogen, creatinine, glucose, total protein, and electrolytes (Na, K, Cl) Urinalysis: Macroscopic (dipstick), pH, specific gravity. Microscopic examination done if protein, nitrates or blood are present on the macroscopic exam Serum pregnancy test in female patients of childbearing potential

6.3.3

6.3.4 6.4

Informed Consent

All p-ospective patients will have the study explained by a member of the research :ea~ The nature of the HMM procedure will also be explained along with potential hazards and possible adverse reactions. Prior to the initiation of the study, acknowledgement of the receipt of this information and the subjects freely tendered offer to participate will be obtained in writing from eacn subject in the study. Those patients under the age of consent and over the age of 6 will voluntarily assent to the study under the same circumstances and their parent or legal guardian will sign the consent form. 7. Prescribed Medications 7.1 Current medications will be documented as to name, dose, frequency and duration of therapy: 7.1.1 The patient will provide assurance that they understand and take their asthma medications correctly. Additional concomitant medications will also be documented and recorded.

7.1.2

8. Study Conduct 8.1 Subject Assignment 8.1.1 Subjects will be placed on the study as they re seen in the clinic and agree to consider being on the study after the maneuver has been explained

8.2 Visit Procedures 8.2.1 On each visit the patient or parent will complete the "clinical Severity" questionnaire, and a brief questionnaire to affirm that the inclusion / exclusion criteria have not been compromised. In addition, each patient will undergo a brief assessment and be questioned about any adverse events since the last visit Each patient will be asked to demonstrate her/his ability to perform the Peak Flow measurements. The diary of each patient will be reviewed foro accuracy and completeness.

8.2.2 8.2.3 8.2.4

8.3 Dietary/Meals The subjects will be asked to maintain their normal diet and eating habits including their normal coffee/caffeine consumption during the study period. 8.4 Drug Administration All subjects will take their medications as prescribed prescribed and required. 8.5 Safety Assessments 8.5.1 Vital signs (Blood Pressure, heart rate and temperature) will be monitored on each of the 12 visits by their primary physician as

8.5.2

Ad 5-se Events will be monitored throughout the study. Subjects will be ins-ructed to inform the study physician and or the study nurse of any untoward, unusual or adverse events that have occurred since the preceding visit.

9. Ad.erseEver.;s 9.1 All adverse events occurring during this study will be recorded on the case report form provided. The investigator will review each event and assess its relationship to study events as to whether the event is unrelated, unlikely to be related, possibly related, probably related, or almost certainly related to the study procedure. 9.2 Each sign, symptom, or other adverse event will be graded on a 3-pointseverity (mild, moderate, or severe) and will be recorded as to the date and time of onset, time relationship to the injection of the test agent, the duration of the event and the outcome of each event. This information will also be recorded on the case report form. 9.3 The definitions for rating severity will be the following: Mild Moderate Severe Easily tolerated and does not interfere with daily activity Interferes with daily activity but subject still able to function Incapacitating and requires medica intervention

9.4 Serious Adverse Events: If any of the above adverse events are "serious" as defined by the FDA CFR: 21, special procedures will be followed. All serious Adverse Events (SAE's) will immediately be reported by telephone to the sponsor, followed by a written report within 5 calendar days, whether or not the SAE is deemed study related. All SAE reporting will adhere to the FDA reporting regulations. The IRB will also be notified concerning any SAE. 9.5 The definition of a Serious Adverse Event (SAE) is the following 1. Death 2. Life threatening events 3. Events which are permanently disabling or incapacitating 4. Events requiring hospitalization or prolonged hospitalization 5. Any congenital anomaly, cancer, or drug overdose 9.6 Adverse Events, whether serious or non-serious, will be followed to their resolution regardless of whether the subjects are still participating in the study. Where appropriate, medical tests and examinations will be performed to document the resolution of the event(s). The outcome may be classified as recovered, persists (a chronic condition is diagnosed), died, or lost to follow-up. 10. Removal of subjects from the Study 10.1 Freedom to withdraw: All subjects and their legal guardian (when applicable) will be advised that they are free to withdraw from the study at any time. The Investigator may remove a subject from this study if he feels this action is in the best interest of the subject. When a subject withdraws from the study, all of the safety data normally required at the end of the study should be obtained it possible.

10,2 Acverse Events: Subjects experiencing adverse reactions should be foiowed until the reaction has resolved. The investigator will administer appropriate =_ : - .6 and/or definitive therapy throughout the study or insure that the pattents physician has been notified and she/he agrees to manage the event. 1C3 Replacing Subjects: Subjects withdrawing or removed from the study for any reason will be replaced 11. Pharmacokinetic and Statistical methods Changes in all clinical and biochemical markers will be summarized using descriptive statistics. In addition, a longitudinal assessment of the PFT's, Peak flow measurements, Medication requirements and number and duration of asthma attacks will be made.

12. Study Report 12.1 Case report Forms will be provided for each subject. The investigator will assure that all entries onto these forms is complete and accurate. 13. General 13.1 Protocol deviations / Amendments: Deviations from this protocol will not be permitted, except as a medical emergency as determined by the Investigator. If deviations are required to protect the subject, the Investigator will notify the sponsor immediately, and submit documentation to the IRB within 10 working days The Investigator can initiate amendments to the protocol. If agreement is reached concerning the need for a modification, a formal amendment should be made to the protocol. The IRB must approve all revisions and/or amendments to this protocol in writing. 13.2 Institutional Review Board: This protocol, informed consent, assent form, and any amendments to the protocol will be reviewed by the IRB prior to initiation. The study will not be initiated without the approval of the IRB, whose operations must be in compliance with CFR 56; Title 21. Written notice that the protocol and informed consent / assent forms have been reviewed and approved by the IRB will be submitted to the Investigator and the Sponsor prior to study initiation. 13.3 Study Termination: The Investigator reserves the right to discontinue this study for safety reasons at any time. This is in collaboration with the sponsor 13.4 Study Records: All records and documents pertaining to the study will be maintained by the Investigator, and will be available for inspection by the sponsor or the Food and Drug Administration at any time.

10

APPENDIX I
Clinical Characteristics of Asthma

MILD Intermittent FEV- or PEFR > 80% of predicted =E- .ariabllity < 20% Exacerbation's are brief Symptoms ^ 2x/week Nighttime symptoms s2x/month asymptomatic between exacerbations

MILD Persistent FEVT or PEFR > 80% predicted FEF variability between 20% and 30% Exacerbations may affect activity Symptoms > 2x/ week BUT < 1 x/ day Nighttime symptoms > 2x/ month medication use prn

MODERATE Persistent FEVi and PEFR > 60% and 80% predicted FEF variability > 30% Exacerbations a 2x/ week and activity is affected Symptoms are daily Nighttime symptoms > 1 x/ week Require daily use of short acting beta agonists

SEVERE

Persistent FEVT and PEFR < 60% predicted FEF variability 30% Exacerbations frequent Symptoms are continuous Nighttime symptoms frequent Activity is limited by the disease

11

APPENDIX II
"Heimlich Maneuver for Asthma" Physician Record Name of Patient: Date of Examination: Height: Weight: / / Race: Black Physician: Age: , White Sex: M , Orrentel ,F

, Other

Historical data: 1. Age when fist diagnosed with asthma? 2. Number of Emergency room visits for asthma in the last 12 months? 3. Number of "attacks" of asthma in a week" 4. Number of visits to your physician in the last year? 5. Number of time you awake with asthma symptoms in a week? 6. Medication history: Name of medication Frequency of use , Month? , Month? ,

b, c. d. 7. Any immediate family members with asthma? Parents 8. Any family members who smoke? Father 9. Do you use Peak Flow meters at this time? 10. Have you ever had a Lung function test? , Mother ,Brothers , Brother ,Sisters , Sister _

= -~onary Testing: ~E-R FVC

FEVt

FEV1/FVC

FEF25-75

12

A P P E N D I X III SEVERITY OF ASTHMA and ASSOCIATED SYMPTOMS I, Introduction

Patient Name: Medical Record No:

Person completing this form

Date:
. Patient: D, parent/guardian

P ease rate the following symptoms by marking the lines according to severity: II. Severity of Asthma Symptoms None 0 1 Cough Wheeze Chest tightness Exercise tolerance Total Asthma Symptoms Unbearable 10 _ _

III. Total Assessment of Symptoms Please keep in mind your previous responses regarding your individual symptoms, please rate your overall symptoms using the following scale: 0 Key to Symptoms: 1<-mild->3 0= 1 -3 = 4-6 = 7-9 = 10 = 4<moderate-->6 7severe- >9 1 2 3 4 5 6 7 8 9 10

None Mild - signs and symptoms alleady present but minimal awareness; easily tolerated Moderate - Definite awareness of signs and symptoms which is bothersome but tolerable Severe - Sign/symptom is hard to tolerate, may cause interference with activities of daily living and/or sleep Unbearable - Can't function, can't sleep, can't work, miserable, etc.

IV. Severity Based on Quality of Life Good 0 1 General quality of life 0 = 2 3 4 5 6 7 8 9 Very Poor 10

Symptoms do not interfere with quality of life

1 -3 = Miid - trivial or insigniiicant impact of symptoms on work, school and other activities

13

---:=

::= =-.-.--:: :esc = " " : - / e i i e n t or annoying is affected by symptoms at work, school, :- :_ - : ere- a:: , i ss; performance at work or school d occasionally (once or twice a week): steep is disturbed significantly once a week; social or recreational activities are occasionally avoided because of less enjoyment of these activities.

7-9 = Severe-significant. troublesome or disturbing impact on work, school or sleep; efficiency of performance at work or school is adversely affected to a significant degree or on a daily basis: work or school days missed because of symptoms and or physician visits; sleep is disturbed significantly twice weekly or more; social and, or recreational activities often avoided and enjoyment of activities diminished significantly 10 = Very severe - sleep disturbance most nights; symptoms significantly impair work or school performance as well as social and/or recreational activities V. (A) Past Medications (including alternative medications) that you have used in the past and how effective were they? 1} Asthma Not Effective Very Effective

2) Other

(B) Present Medications 1) Asthma Not Effective Very Effective

2) Other

14

APPENDIX IV
References: 1. Horwrtz RJ. 3^sse WW; Inflammation and asthma. Clin Chest Med 1995;16:583620 2. Heimlich HJ. Hoffmann KA, Canestri FR: Food-Choking and Drowning Deaths Prevented by External Subdiaphragmatic Compression. Ann Thoracic Surg 1975; 20(2):188-195 3. Heimlich HJ, Patrick EA; The Heimlich maneuver - Best technique for saving any choking victim's life. Postgrad Med 1990; 87(6): 38-53 4. mech of Heimlich - kinetic energy 5. anecdotal reports in recent years 6. Koop CE: The Heimlich maneuver. J US Pub Health Serv 1985; 100(6): 557

7. National Center for Health Statistics: National Health Interview Survey, 1994, DHHS Pub. No. (PHS) 95-1521 (Hyattsville, MD: National Center for Health Statistics, 1995 8. Weiss KB, Gergen PJ, and Hodgson TA: An Economic Evaluation of asthma in the United States. N Eng J Med 1992; 326:862-866 9. Kay AB: Asthma and inflammation. J Allergy Clin Immunol 1991 ;87:893-911 10. studies showing minimal intrapulmonary pressure increase

15

The Protocol

Subject: Date: From: To:

The Protocol T e. 22 Jan 2002 10:40:55 -0500 Charles H. Pierce" <charles@piercel.net> Henry J. Heimlich. MD" <hekalich@iglou.com>

Her.ry, Erie, we have discussed almost each time I have been there for the need to make this protocol as scientific as possible and I am sure you have sensed my mild concerns about having no controls and relying on "historic" controls. The scientific community demands this especially for something that is new. It seems that the literature is full of studies proving that one just cannot compare one year with the next especially in kids. Add to that the 30% placebo response seen in most asthma studies and I think (thought) we had a problem with selling what we now have to any credible group. After discussing the concept with some of the group that sees asthma patients at the Cincinnati Children's I now am convinced that we have to be very rigorous scientifically and devise a control group where the parent does "something" (other then the HMM). The reason for this is that there is a clear "healing" factor in touch by a parent of almost any condition. One of the concerns is that the parent will want this to work so bad that they will encourage the reduction of medications without any real basis. We could indirectly be responsible for someone getting into trouble no matter how much we "Believe " that the procedure works, For this reason, I am in the process of revising what we have to control for factors such as the unsteady course of the disease in the pediatric population, parental touch and involvement, and other factors that are known to be operative such as race. Whereas this will make the protocol larger and more difficult to follow, it is the only way that we will be able to get the involvement of the scientific community so that the procedure can be taken seriously. It may mean that the number of patients will have to increase and will certainly mean that the two groups will have to be matched as to several factors. Incidentally, Dr. Michelle Lierl was one of the group with whom I spoke. She seemed particularly dubious which suggests that if she is involved in the Rotary Camp for Asthmatics at Camp Allyn that she would absolutely not allow this to be taught - unless we can convince her otherwise. Bit of a purist but to date she sees no evidence why this would work and is a bit miffed at the anecdotal approach. Sorry for the length of this note but wanted to get this on the table so when I return from Munich next Wednesday, we can get started in earnest. Do recommend that we look into the rules for applying to the NIH alternative medicine section for funding. Best regards, Charles.

Charles H. Pierce, MSc, MD, PhD Associate Director, Clinical Trials Office Children's Hospital Medical Center of Cincinnati Phone - 513 681 4084 Email address: Personal Web site: Consultant Web site: Fax - 513 681 4094 Charles@Piercel.net http://Dr.Pierce 1.net www.pmci.org

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1/22/02 11:02 AM

D I S T R I C T

# 6 6 7 0

ROTARYNEWS
DISTRICT GOVERNOR. TOM POWELL MARCH, 2002

HOST CLUBS/FAMILIES NEEDED GROUP STUDY EXCHANGE We are planning for two incoming GSE teams this year and are now looking for Host Clubs and Host Families for both teams. The first will be here for the month of April and will be visiting from District #9100 in Africa. The second team will be here for the month of May and will be visiting from District #4720 in Brazil. Please contact your Club leaders and let them know of your interest in hosting, or contact Dave Sunderland at 937-233-0741 or email: suiulerdapaflaol.com ANOTHER CONNECTION IS MADE

CLUB RANKINGS FOUNDATION GIVING Here is the report on Club rankings for giving to The Rotary International Foundation from July 1, 2001 through January 31, 2002: TOTAL ANNUAL GIVING: l.OAKWOOD-$13,895 2. WILMINGTON - $6,475 3. PIQUA - 5,000 PER CAPITA GIVING: l.OAKWOOD-$120.83 2. MT. STERLING - $10938 3. NEW CARLISLE - $91.51 Congratulations to these Rotary Clubs and to the Rotarians for their investment in the work of our Rotary International Foundation!

Rotarian Maria Herminia of the San Antonio de Padus Rotary Club (Argentina) recently came to visit her son, a foreign exchange student in Washington Court House. Maria asked the Rotary Club of Washington CH to partner in a project in rural San Antonio at a school for children with disabilities. The Rotarians at Washington CH generously matched the amount raised by Maria's club. With a fund match from Rotary, the school has had building repairs, fresh paint and has purchased a new computer. This partnership will be ongoing for both Clubs.

MATCHING GRANT APPROVALS The District Allocations Committee has recently approved three Matching Grants that will have a positive impact on people's lives. The Rotary Club of Bellefontaine has partnered with the Rotary Club of West Chester for a project to equip an orphanage in Romania. The Rotary Club of Mason-Deerfield has been approved for a project in Paso Real, Nicaragua for a feeding station to feed 200 people at least one meal a day. The Rotary Club of Blue Ash/Montgomery is doing a project in Las Flores, Nicaragua creating a vocational school to teach people carpentry and sewing. In all three cases, Rotarians from our District will be traveling to these locations. We congratulate these Rotary Clubs for reaching beyond the walls of their community!

KETTERING CLUB MOVES The Kettering Rotary Club has changed its meeting place to the Presidential Banquet Center off of David Road in Kettering. The meeting time remains 11:30 on Wednesdays.

BUMPER STICKER GEMS My karma ran over your dogma. When you do a good deed, get a receipt in case heaven is like the IRS. It's lonely at the top, but you eat better. The weather is here, wish you were beautiful. Smile - it's the second best thing you can do with your lips. I came, I saw, I did a little shopping. If money could talk, it would say "goodbye." Honk if you love cheeses. Who cares who's on board? If it's too loud, you're too old. This is not an abandoned vehicle. We're staying together for the sake of the cats. Wink, I'll do the rest. So many pedestrians, so little time.

ROTARY EDUCATIONAL CORNER THE DISTRICT CONFERENCE Unfortunately, most Rotarians have never attended a District Conference and have not experienced one of the most enjoyable and rewarding privileges of being a Rotarian. A District Conference is for all club members and their spouses, not just the club officers and committee members. The purpose of the District Conference is to share fun and fellowship, hear inspirational speakers, enjoy entertainment and to have discussions on matters that makes being a Rotarian even more meaningful. One of the added benefits of attending is the opportunity to become better acquainted with members in an informal and fun setting. Lasting friendships are sure to grow from the District Conference experience. Please mark your calendar for the weekend of May 17th19th and send in your registration and reservation now.

ASTHMA IN THE CARD3BEAN The Rotary Club of Cincinnati has begun a project aimed at resolving the high mortality and morbidity rate from asthma medical problems in the Caribbean countries. The incidence and death rate there is more than twice the rate of the U.S. and Canada. The yearly average is more than 12,000 Emergency Room visits to treat patients in an asthmatic crisis. Cincinnati Rotarians Dr. Henry Heimlich and Dr. Charles Pierce are spearheading the project. They are looking to form partnerships with other Rotary Clubs in our District. Please contact Dr. Pierce at 513-6814084 or via email at: charles(q),pierce.net

DISTRICT CONFERENCE You should have just received your packet in the mail covering the District Conference that will be held May 17th - 19* at the Marriott Griffin Gate Resort in Lexington, KY. This promises to be a wonderful event and a great way to spend the weekend. If you have not yet received a Registration packet, please contact your Club President or Assistant District Governor. Your prompt response will assure your reservation.

Visit our District Website at: www.rotary6670.org for all kinds of interesting information

R. I. CONVENTION 2002 BARCELONA, SPAIN For more information you can visit the web at: www.ri.convention.bcn2002.org

mailbox:///C|/WINDOWS/App!ication%20Data/Mozllla/Profiles/de...

Subject: Our WCS grant application From: "Charles H. Pierce" <charles@piercel.net> Date: Tue. 16 Apr 2002 22:40:10 -0400 To: "Henry J. Heimlich, MD" <heimlich@iglou.com> CC: "Bob McElroy" <Bob@mediasign.com>, "Ute Papke" <UteMunic@one.net>, "JohnNeuhart" <JohnN5@fiise.net>, "Tom Powell, DG 6670" <tapco3@aol.com>
Hank, It was a great trip to Barbados. The best news was that the Directors of the Rotary Club of Barbados South has voted to commit $5,000 US to the project and Dr, St. John, who is the chairperson of the Department of Pediatrics of the Queen Elizabeth Hospital is very interested in doing the study on the "Heimlich Maneuver for Asthma". This means that we have a chance to do this project this Rotary year. Will be applying to our foundation for part of the rest and hope you can help with the rest from your sources. I am excited about working with this closed and well defined population where the problem of asthma and deaths from asthma is astronomically high. The timing was interesting because that Club in conjunction with the Red Cross of Barbados has put together some posters on life saving maneuvers of which one is (of course) yours. Brought them back to show you this week. They were most interested in the use of the maneuver for drowning and asthma and told me they were planning on making up at least another poster to include these. As you know, I gave a public lecture to asthma patients and the Asthma Association arranged for me to be on "Morning Barbados" TV program giving me a chance to mention the method for asthma to a national audience. At the lecture, it was also well received so we will see what comes of this. They were most pleased and interested in your interest and willingness in coming down and are thinking of a high level reception and a large public lecture. We can discuss this as things progress. Many thanks for your encouragement and see you Thursday. Charles. PS: Have attached a current draft of the proposed WCS project. final but close to it. C Charles H. Pierce, MSc, MD, PhD 5563 Regimental Place Cincinnati, Ohio 45239 Fh-r.e - 513 681 4084 pUersonat W e b ^ e , Consultant Web site: Fax - 513 681 4094 JJzzHfIerce^ne www.pmci.org Best regards, This is not

I of I

4/17/02 8:30 A M

Original Message Subject: Re: protocol and funding Date: Fri, 19 Apr 2002 17:29:34 -0400 Fr:::,: "Henry J. Heimlich" .-eimlichhhqlou.com> To: Charles@Pierce1.net -ear Dr. Pierce, Sorry we didn't meet Thursday. I'm glad your trip to Barbados went well. I was uncertain if you got my previous message regarding NIH fundirg, so I will repeat it here. -ere is the link to the funding page: http://r..cam. nih.gov/f:/research/gjj Ideldnes/ After reviewing the type of funding available, I think the R21 grant is the one we're looking for ( http::/nccam. r i: i >; ;v/fi/research/c|Uidelines/r21grants.html ) . : . Also, attached is an initial draft of the procedures for the study. Feel free to change them. Dr. Heimlich has a meeting on Thursday morning, which he could not get ;ed. If you still wish to meet with me and discuss these things, please let me know. look forward to hearing from you. Eric Spletzer, PhD The Heimlich Institute

mailbox:///C - W[NDOWS/Appiication[,020DataMozillaProfiles def...

Subject: Re: Our WCS grant application From: 1MB Papke <utemunic@one.net> Date: SaL 20 Apr 2002 08:10:15 -0700 T: "Charles H. Pierce" <charles@piercel.net>, "Henry J. Heimlich. MD" <heimlich a iglou.com> CC: "Bob McElrov" <Bob a mediasien.com>, "John Neuhart" <JohnN5'aruse.net>. "Tom Powell. DG6670"<tapco3aaol.com> "
_

Thanks for the copy. You have been very busy indeed. car. dc - helf facilitate this. i - - jrea; weekend. Best wishes I r i g i n a . ] Message

Let me know what I

mailbox:///Cj.'WINDOWS/Appiicaiion%00Data/MoziUa^>rofiles/def...

Subject: Re: protocol and funding From: Dr. Charles Pierce" <charles@piercel.net> Date: Mon. 22 Apr 2002 01:12:48 -0000 To: Henry J. Heimlich" <heimlich@iglou.com>
Ha.i:.- Z- = ii prob_erns and w i i l be away all n e c t week. Soory t h a t I did not ce- - talk to you e a r l i e r . c Grant i d e a s o u n d s l i k e a p l a n . W i l l you downloa - . fi_-s ar.ci ^ e t us l o o k a t t h e s e a f t e r t h e 2 8 t h . :s Thanks, Charlees

mai!box:///C|AVINDOWS/Application%20Data/Mozilla/Profi]es/def...

Subject: Re: HM for asthma intro From: "Charts Pierce" <charles^piercel.net> Date: MOIL 22 Jul 2002 22:25:16 -0400 To: "Heniy J. Heimlich" <heimlich@iglou.eom>
--._ ::.;::':;rd:ed the Introduction you sent as you sent it and also *d see 11.) what I got back from the statistics department. Have attached the updated Protocol and, in addition, the full text of what Judy _--,-E==r. ser.t. v ^ , , ,.,-; i n ^ + - ^ +-K^<- ,-,v-^ t a l l / K ^ o <-,-, i-,i/n place as ,,^ are dealing You will note that more talk has to take ^ 1 - , ^ ^ - ^ we ^^-^ ^ ^ ^ T 4 .-,,with an unpredictable condition. ?~. having tth eTO Opprpre aa IIInfmed CCConnt dddument aad ttt IRB Mltline (required at the CCHMC). Will pass these on when they are ready. This sure is a long process, would like t- ge n with it but guess we will just have to be patient. Best, Charles. Zharles H. Pierce, MSc, MD, rhD Associate Director, Clinical Trills sffice ri innati Children's Hospital Medical Center 6814094 Personal S i t i l http://Dr.Piercel.net Consultant Site: www.pmci.org Original Message Fro: "Henry J. Heimlich" <heimlich@iglou.com> _ : : ' rr.srles@piercel.net> Sent. Monday, July 22, 2002 11:12 AM Subject: HM for asthma intro See attached.

1 of J

7/23/02 9:00 A M

A Prospective Randomized Controlled Study on the Utility of Using a Modified Heimiich Maneuver (HMM) compared to a Modified Chest Massage (CMM) as an adjunct In the Management of Mild to Moderate Asthma in Children

Protocol 080

This document is a confidential communication. The confidential information is provided to you for your review for purposes of evaluation. By accepting this document, you agree that the information contained herein will not be disclosed to others without written authority of Cincinnati Children's Hospital Medical Center except for the Institutional Review Board

<lnvestigator> <Title and Departmentt The Cincinnati Children's Hospital Medical Center Cincinnati, Ohio

22 July 2002

CONFIDENTIAL

Introduction According to the National Institute of Allergy and Infectious Diseases of the National Institutes of Health, more than 17 million Americans suffer from asthma.1. More than 5000 Amer.cans die annually (an average of 14 persons a day) during acute asthma attacks.2,3 A disproportionate number of the deaths occur in children. The annual cost of asthma is estimated to be over 12 billion dollars and it remains the number one cause of missed days at school.4 Asthma is, unquestionably, a worldwide problem with significant morbidity and mortality despite the availability of many therapies. Asthma attacks consist of prolonged spells of dyspnea and shortness of breath that can be fatal. The air passages in the lungs of asthmatics are chronically swollen and inflamed.5,6 Mucus fills the airway and, when the bronchi constrict, acts as a valve, i.e., when the asthmatic breathes in, air is drawn past the mucus; on exhaling, mucous plugs clog narrowed airways and air cannot get out. Trapped air distends the lungs, making both inhalation and exhalation difficult. The term "attack" refers, in this document, to a sudden increase in these symptoms. Anecdotal reports of Heimlich maneuvers having a beneficial effect in asthma have appeared in recent years.7. Asthmatics have reported that an acute attack appears to stop when the Heimlich maneuver is used, resulting in the victim being able to breathe normally following the procedure. When the Heimlich maneuver is used prophylactically, a reduction in the number of attacks and a general improvement, including a lessening need for medications, has been reported. This concept has not been tested and is the basis of the present study. To explain these reports, the function of the Heimlich maneuver must be considered. The Heimlich maneuver consists of pressing on the upper abdomen, which has the effect of elevating the diaphragm. The upward movement of the diaphragm diminishes the volume of the chest cavity, thereby compressing the lungs uniformly. This results in a flow of air out of the alveoli through the tracheobronchial tree toward the mouth. obstruction.8 The airflow transmits kinetic energy to foreign substances, solid (food) or liquid (water), dislodging the Tests on ten volunteers demonstrated the Heimlich maneuver expels a volume of 940 cc (0.94 L) of air from the lungs in approximately 1/4 of a second. The average flow rate is 205 liters per minute.8 This airflow was considered to be sufficient to carry foreign substances out of the airway. Similar application of Heimlich maneuver to drowning victims causes water to be expelled from the airways, which flows out of the mouth.

 5 a :o-"mon misconception that expulsion of a foreign substance is the result of --eased intrapulmonary pressure. On the contrary, studies show there is minimal intrapulmonary pressure increase.8. The physical principle that enables the Maneuver to expel foreign substances from the airway is energy. Kinetic energy of the airflow, the energy of motion, is transmitted to a foreign object ejecting it from the airway.9,10 The kinetic energy provided by airflow is equally effective whether the foreign object is large enough to completely obstruct the airway, or is a small enough to only partially obstruct the airway. Fluid can be considered as a obstructing foreign substance, and is also readily expelled by the Heimlich maneuver.

As a working hypothesis, the anecdotal observations reported by asthmatics may partly be explained by considering mucus, which impedes or prevents exhalation of air in an asthma attack, to be analogous to foreign substances blocking small airways. Mucous plugs are semi-liquid material, lying somewhere between a food object and water in their properties. It is postulated, therefore, that the Heimlich maneuver uses the asthmatic's trapped air to expel the mucous plugs from the airway, allowing the victim to breathe normally. Since mucus is a relatively light, mobile substance, it is anticipated that the Heimlich maneuver can be done more gently and achieve the same results. This is referred to as a modified Heimlich maneuver (HMM). In 1985, Dr. C. Everett Koop, then Surgeon General of the United States, declared, "The Heimlich Maneuver is safe, effective, and easily mastered by the average person. It can be performed on children and even on one's self."11 Since the HHM is identical to the Heimlich maneuver in form and function, although performed more gently, it is anticipated to be equally safe. Asthma patients can, therefore, treat their own attacks or have someone else perform the HMM on them. A confounding factor in the proposed study is the physical contact inherent in using the HMM. That touch has an impact on "healing", in general, is not disputed. Studies have confirmed the value of touch in treating disease12, which is beyond the placebo effect.13. One of the adjuncts believed to improve a child's response to her/his condition if not the condition itself is parental involvement and the concept of "touch." What is unknown is the effect of "touch" and manipulation on the condition of asthma. It has been shown that intercostal muscle fatigue due to increased expiratory effort required in asthma is associated with the asthmatic process and that the increase in the functional residual capacity in asthma is influenced by the persistent inspiratory intercostal and

accessory muscle activity during expiration.8 That this leads to muscle fatigue and is the cause of chest discomfort is surmised. Since "touch" can take many forms, brief massage of the intercostal muscles of the back (designated herein as CMM) has the potential to reieve the discomfort and also supply ""ouch" "o pattents wiih asthma. It is proposed to study the effect of the HMM on the course of an asthmatic over a period of 1 year. Two forms of physical touch (HMM and CMM) will be applied under the same circumstances in matched control subjects with mild to moderate asthma to evaluate and neutralize the possible "placebo" effect of "touch."

2. Study Objective / Significance To determine the role of the Modified Heimlich Maneuver (HMM) compared to a prescribed massage of the intercostal muscles (CMM) in reducing the frequency of attacks and reducing the requirement for rescue medications in Mild Persistent and Moderate asthma by the following: 2.1 2.2 2.3 2.4 Use of the HMM / CMM to relieve the symptoms of an acute asthmatic attack. Use of the HMM / CMM prophylactically to reduce the frequency of asthma attacks. To assess the change in the patient's physician's use of medications following regular HMM/CMM use. To assess the ease of teaching asthmatics to use the HMM on themselves and/or the ease of teaching parents/guardians in the use of the HMM or CMM on their children.

3. Summary of Study Design / Research Plan 3.1 Overview: 3.1.1 Referred patients will be assessed as to the severity of their symptoms of asthma and the number of times in the prior 12 months that they have had what they call an "attack" of their asthma The patient is then to be screened to insure that their history and present condition comply with the Inclusion / Exclusion criteria established Where applicable, meaning that the patient has the psychomotor skills and can be taught the procedure, a pulmonary function test will be performed. Each patient will also be instructed regarding to completion of the diary and the performance of peak expiratory flows (PEFR) with the peak flow meter. Patients will be matched as possible for age, height, weight, and race and randomized to receive either the HMM or the CMM approach as an adjunct to their physicians management of their condition. Each patient and the patients parents or guardian, when applicable, will be taught how and when to perform the modified Heimlich maneuver (HMM) or the

3.1.2

3.1.3

3.1.4

3.1.5

chest wall massage (CMM) so that it is clear that these procedures can be done in a correct and consistent manner. 3.1 6 Each patient/parent will be given a diary and instructions as to how it is to be completed and the reasoning behind the questions asked. The patient will be encouraged to share this with her/his primary care giver. Each patient will be asked to perform a PEFR determination before and after a HMM / CMM twice a week on non-consecutive days. It will be recommended that at least one of these be an early morning event. Each patient will be asked, in addition, to perform the HMM / CMM whenever they sense that their condition is worsening to the point of becoming an "Attack of asthma". Again, PEFR determinations before and after the HMM / CMM should be done and recorded if possible. The patient will be instructed to follow the Asthma Action Plan recommended by her/his personal physician without delay but with the following modifications: When feasible, perform (or have performed) the HMM / CMM when an "attack" or worsening of symptoms is developing and record this in the diary. When the inhaler medication is prescribed "pm" or as "rescue therapy" and is needed, the patient or parent is asked to perform the HMM / CMM first with a PEFR before and after rf this can be done. In every instance, it is recommended that a PEFR be done prior to and after the event (taking their medication or morning HMM / CMM) or an exacerbation of the symptoms of asthma.

3.1.7

3.1.8

3.1.9

3.2

Flow sheet of study:

Screening M1 M2 M3 M4 M6 M8 M10 M12 Final*

Event
Informed Consent Inclusion/Exclusion criteria History / demographics Complete physical exam Randomization Pulmonary Function Testing 1 Peak Flow Rate (PEFR)2 Procedure conduct assessed Diary training / Evaluation Clinical severity score 3 Safety Labs (Chem.CBC, UA) Adverse Events

X X X X X X1 X2 X X X3 X X

X X X X X

X X X X X

X X X X X

X X X X X

X X X X X X

X X X X X

X X X X X

X X X X X X

X X X X

* The "final visit" will be within 1 month of the 12 month visit or at the time of that visit if appropriate. 1 Pulmonary function will be performed on patients demonstrating the psychomotor skills required to perform the test correctly 2 Peak flow rates (PEFR) will be determined at the study visits by those with the skills to perform the procedure as demonstration that the patient knows and is comfortable with the procedure 3 The clinical severity score will be determined using the analog scales as per appendix III

3.3

Questions to be answered: Are the adjunctive modalities effective in modifying or treating asthmatic symptoms and is there a difference between the two groups

3.3.1

Is HMM or CMM an effective procedure for the emergency relief of the symptoms of an attack (acute exacerbation) of the symptoms of asthma? Is HMM or CMM an effective temporary measure for the relief of the symptoms and improvement in pulmonary function (PEFR) in patients with asthma? Does HMM or CMM reduce the number of acute attacks of asthma from that which the patient had experienced in the 6 months prior to the study and in the first two study visits? Does HMM or CMM reduce the reliance on regular or rescue medications? Does HMM or CMM reduce the need for prn medications? Does HMM or CMM enable the patient's physician to reduce the medical regimen? Does the use of HMM or CMM reduce the number of missed school days? Does the use of HMM or CMM reduce the number of ED visits

3.3.2

3.3.3

3.3.4 3.3.5 3.3.6

3.3.7 3.3.8

4. Investigator and Facilities 4.1 Principal Investigator Department of Pediatrics Cincinnati Children's Hospital medical Center 5. Subject Selection 5.1 Patients Forty-Eight patients from the asthma clinics who meet the criteria of mild persistent or moderate Asthma (Appendix I) and who voluntarily consent or assent (with parental consent) to the therapy will be used in this study. There will be twenty-Four in each group 5.2 Inclusion Criteria 5.2.1 Patients with a documented and well established history of asthma requiring regular medical therapy of any type Diagnosis of Mild Persistent asthma or Moderate asthma according to the accepted criteria for this diagnosis (Appendix I) Patients of all racial and ethnic backgrounds and of both sexes who are greater than 5 years of age but less that 16 years of age. In general good health except for the diagnosis of bronchial asthma.

5.2.2

5.2.3

5.2.4

5.2.5

Have the psychomotor skills to learn and perform pulmonary function testing and/or peak flow rate measurements. Willing to keep a diary of medication use and PEFR determinations as recommended. Have no medically or clinically significant illness of the lungs or abdominal organs which in the view of the Principal Investigator might place the patient at any risk Patients who voluntarily assent to be in this study and whose parents are willing to give permission for their child to be in this study

5.2.6

5.2.7

5.2.8

5.3

Exclusion Criteria 5.3.1 History of clinically significant renal, hepatic, endocrine, oncologic, cardiovascular disease, or any other condition, which in the opinion of the Investigator, would jeopardize the safety of the patient or impact on the validity of the study results History of severe, continuous or intractable asthma History of smoking, Chronic bronchitis, emphysema or Cystic Fibrosis or any other pulmonary disease Recent surgery especially abdominal and thoracic surgery History of conditions where the HMM is contraindicated such as ulcers, abdominal hernias, diaphragmatic hernias, artificial heart valves, abdominal aneurysm and pregnancy. History of any condition where the CMM would be contraindicated such as a skin condition or an inability to position oneself to receive the massage Unable or unwilling to give voluntary informed consent / assent or whose parents do not freely consent for their child to participate in this study.

5.3.2 5.3.3

5.3.4 5.3.5

5.3.6

5.3.7

6.

Screening procedures The Principal Investigator or her/his designee will assess the following screening procedures at the time of screening: 6.1 Medical History A complete medical history, including a detailed list of medications taken (Drug dose, frequency of use, start and stop date) for all medications taken since the diagnosis of asthma was made. In addition, other prescription medication used in the month prior to the start of the study. For females of childbearing potential, the birth control methods used will be assessed.

The documentation of a twelve month history of asthma requiring the use of asthma medications prescnbed on a regular or prn basis and used appropriately by the patient will be determined prior to proceeding to the next step. 5.2 Physical Examination 6.2.1 6.2.2 Height (in inches) and weight (in pounds). Vital signs while seated (respiratory rate, heart rate, blood pressure and temperature). Pulmonary function tests including FVC, FEV,, FEF 25-75, and the various calculations made from these tests to be done on patients possessing the psychomotor skills required for a standard PFT. Peak Flow rate testing (PEFR) using a Wrights Flowmeter plus PEFR using the device the patient will use while ambulatory (with those patients possessing sufficient skills to perform the provedue)

6.2.3

6.2.4

6.3

Clinical Laboratory tests: Results of laboratory tests taken within 3 months of the initial visit or at the initial visit are to be assessed and those beyond the reference ranges accepted for the study only if the Investigator determines that there is no risk to the patient should they have the HMM or CMM procedure done as per the protocol. 6.3.1 Hematology: Hemoglobin, Hematocrit, WBC, differential eosinophil count, RBC, platelet count including an

6.3.2

Serum Chemistry: Alkaline phosphatase, ALT, AST, LDH, Total bilirubin, Urea nitrogen, creatinine, glucose, total protein, and electrolytes (Na, K, Cl) Urinalysis: Macroscopic (dipstick), pH, specific gravity. Microscopic examination done if protein, nitrates or blood are present on the macroscopic exam Serum pregnancy test in female patients of childbearing potential

6.3.3

6.3.4 6.4

Randomization Patients will be randomized into the therapeutic modality group except that the second patient of the matched pair would receive the available adjunctive modality. The objective being to have at least two patients receiving each modality as closely matched for height, weight, age and race as possible.

6.5

Informed Consent All prospective patients will have the study explained by a member of the research team. The nature of the HMM or the CMM procedure will be clearly explained along with potential hazards and possible adverse reactions that could be encountered. Prior to the initiation of the study, acknowledgement of the receipt of this information and the subject's freely tendered offer to participate will be obtained in writing from each subject in the study. Those patients under the age of consent and over the age

of 6 will voluntarily assent to the study under the same circumstances and their parent or legal guardian will sign the consent form.

7. Prescribed Medications 7.1 Current medications will be documented as to name, dose, frequency and duration of therapy: 7.1.1 The patient will provide assurance that they understand and take their asthma medications correctly. Additional concomitant medications will also be documented and recorded.

7.1.2

8. Study Conduct 8.1 Subjects will be followed monthly 8.2 Visit Procedures 8.2.1 On each visit the patient or parent will complete the "clinical Severity" questionnaire, and a brief questionnaire to affirm that the inclusion / exclusion criteria have not been compromised. In addition, each patient will undergo a brief assessment and be questioned about any adverse events since the last visit Each patient will be asked to demonstrate her/his ability to perform the Peak Flow measurements. Patients will do or have done a HMM or CMM with a PEFR before and after. This is to reinforce the correct technique for the procedure. The diary of each patient will be reviewed for accuracy and completeness.

8.2.2

8.2.3

8.2.4

8.2.5

8.3 Dietary / Meals The subjects will be asked to maintain their normal diet and eating habits including their normal coffee/caffeine consumption during the study period. 8.4 Drug Administration All subjects will take the medications prescribed by their treating physician. 8.5 Safety Assessments 8.5.1 Vital signs (Blood Pressure, heart rate and temperature) will be monitored on each of the 12 visits (4 pre-dose visits, 5 dosing visits, and 3 post dose visits). Adverse Events will be monitored throughout the study. Subjects will be instructed to inform the study physician and/or the study nurse of any untoward, unusual or adverse events that have occurred since the preceding visit.

8.5.2

9. Adverse Events 9.1 AlI adverse events occurring during this study will be recorded on the case report form provided. The investigator will review each event and assess its relationship to study events as to whether the event is unrelated, unlikely to be related, possibly related, probably related, or almost certainly related to the study procedure. 9.2 Each sign, symptom, or other adverse event will be graded on a 3-point severity (mild, moderate, or severe) and will be recorded as to the date and time of onset, time relationship to the injection of the test agent, the duration of the event and the outcome of each event. This information will also be recorded on the case report form. The definitions for rating severity will be the following: Mild Easily tolerated and does not interfere with daily activity Moderate -Interferes with daily activity but subject still able to function Severe - Incapacitating and requires medical intervention 9.3 Serious Adverse Events: If any of the above adverse events are "serious" as defined by the FDA CFR: 21, special procedures will be followed. All serious Adverse Events (SAE's) will immediately be reported by telephone to the sponsor, followed by a written report within 5 calendar days, whether or not the SAE is deemed study related. All SAE reporting will adhere to the FDA reporting regulations. The IRB will also be notified concerning any SAE. The definition 1. 2. 3. 4. 5. of a Serious Adverse Event (SAE) is the following Death Life threatening events Events which are permanently disabling or incapacitating Events requiring hospitalization or prolonged hospitalization Any congenital anomaly, cancer, or drug overdose

9.4 Adverse Events, whether serious or non-serious, will be followed to their resolution regardless of whether the subjects are still participating in the study. Where appropriate, medical tests and examinations will be performed to document the resolution of the event(s). The outcome may be classified as recovered, persists (a chronic condition is diagnosed), died, or lost to follow-up.

10. Removal of subjects from the Study 10.1 Freedom to withdraw: All subjects and their legal guardian (when applicable) will be advised that they are free to withdraw from the study at any time. The Investigator may remove a subject from this study if he feels this action is in the best interest of the subject. When a subject withdraws from the study, all of the safety data normally required at the end of the study should be obtained it possible. 10.2 Adverse Events: Subjects experiencing adverse reactions should be followed until the reaction has resolved. The investigator will administer appropriate supportive and/or definitive therapy throughout the study or insure that the patients physician has been notified and she/he agrees to manage the event. 10.3 will be replaced Replacing Subjects: Subjects withdrawing or removed from the study

10

11. Pharmacokineticand Statistical methods The purpose of this proposal is to assess the effectiveness of the Modified Heimlich Maneuver (HMM) and the effectiveness of prescribed massage of the intercostal muscles (CMM) in reducing the number of attacks in children with mild or moderate asthma. The two primary endpoints are to compare the number of attacks in the past 12 months to the number of attacks in the 12 months after learning one of the techniques and also to compare the two methods. For the first endpoint, each method will be analyzed by using a paired t-test. An effect size is the difference in the pre value minus the post value divided by the standard deviation. If the difference between the two values is large relevant to the standard deviation, the effect size is large. For this study the decision was made that the difference needed to be large before the reduction would have clinical meaning. Therefore, the effect size was set at 0.6. For a two-sided test, level of significance of 0.05, and a power of 80%, 24 children are required. This means that 48 children would be randomized to one of two groups, HHM or CMM. If the two groups are compared with this sample size an effect size of 0.85 with 82% power. Changes in all clinical and biochemical markers will be summarized using descriptive statistics. In addition, a longitudinal assessment of the PFT's, Medication requirements and number and duration of asthma attacks will be made.

12. Study Report 12.1 Case report Forms will be provided for each subject. The investigator will assure that all entries onto these forms is complete and accurate. 12.2 Clinical Report will be submitted to the sponsor at the completion of the study. This report will include a description of the clinical conduct of the study, subject demographics, adverse event listings and the notice of the IRB approval.

13. General 13.1 Disclosure: All members of the Investigators staff have signed confidentiality agreements. All information provided to the investigator dealing with the study and information obtained during the course of the study will be regarded as confidential. 13.2 Protocol deviations / Amendments: Deviations from this protocol will not be permitted, except as a medical emergency as determined by the Investigator. If deviations are required to protect the subject, the Investigator will notify the sponsor immediately, and submit documentation to the IRB within 10 working days The Investigator can initiate amendments to the protocol. If agreement is reached concerning the need for a modification, a formal amendment should be made to the protocol. The IRB must approve all revisions and/or amendments to this protocol in writing.

11

13.3 Institutional Review Board: This protocol, informed consent, assent f c m and any amendments to the protocol will be reviewed by the IRB prior to initiation. The study will not be initiated without the approval of the IRB, whose operations must be in compliance with CFR 56; Title 21. Written notice that the protocol and informed consent / assent forms have been reviewed and approved by the IRB will be submitted to the Investigator and the Sponsor prior to study initiation. 13.4 Study Termination: The Investigator reserves the right to discontinue this study for safety reasons at any time. This is in collaboration with the sponsor 13.5 Study Records: All records and documents pertaining to the study will be maintained by the Investigator, and will be available for inspection by the sponsor or the Food and Drug Administration at any time.

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APPENDIX I ASTHMA SEVERITY GUIDELINES

MILD Intermittent FEV, or PEFR > 80% of predicted FEF variability < 20% Exacerbation's are brief Symptoms < 2x1 week Nighttime symptoms < 2x1 month asymptomatic between exacerbations

MILD Persistent FEVT or PEFR > 80% predicted FEF variability between 20% and 30% Exacerbations may affect activity Symptoms > 2 x / w e e k BUT < 1x/day Nighttime symptoms > 2x1 month medication use prn

MODERATE Persistent FEVT and PEFR > 60% and < 80% predicted FEF variability > 30% Exacerbations > 2x/ week and activity is affected Symptoms are daily Nighttime symptoms > 1 xl week Require daily use of short acting beta agonists

SEVERE Persistent FEVT and PEFR < 60% predicted FEF variability 30% Exacerbations frequent Symptoms are continuous Nighttime symptoms frequent Activity is limited by the disease

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APPENDIX II Adjunctive Therapy in Asthma Physician Record Name of Patient: rate of Examination: Height Weight: / / Race: Black Physician: Age: White , Orrental Sex: M , Hispanic ,F , Other r

Historical data: 1. Age when fist diagnosed with asthma? 2. Number of Emergency room visits for asthma in the last 12 months? 3. Number of "attacks" of asthma in a week" 4. Number of visits to your physician in the last year? 5. Number of time you awake with asthma symptoms in a week? 6. Medication history: Name of medication a. b.
C.

, Month?

, Month?

Frequency of use

d. 7. Any immediate family members with asthma? Parents 8. Any family members who smoke? Father 9. Do you use Peak Flow meters at this time? 10. Have you ever had a Lung function test? , Mother Brothers , Brother , Sisters Sister _

Pulmonary Testing: PEFR FVC

FEV1

FEVi/FVC

FEF25-75

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APPENDIX III ASTHMA SYMPTOM SEVERITY QUESTIONNAIRE I. Introduction

Patient Name:
Medical Record No:
Person completing this form
D

Date:
. Patient:D, parent/guardian

ease rate the following symptoms by marking the lines according to severity. Symptoms None 0 1 Unbearable 10

ii Severity of Asthma

Cough Wheeze

Chest tightness
Exercise tolerance Total Asthma Symptoms

III. Total Assessment of Symptoms Please keep in mind your previous responses regarding your individual symptoms, please rate your overall symptoms using the following scale:

0
Key to Symptoms:

1
1<

2
mild

3
>3

10

4<moderate->6

7<severe->9

0 = 1-3 = 4-6 = 7-9 = 10 =

None Mild - signs and symptoms already present but minimal awareness; easily tolerated Moderate - Definite awareness of signs and symptoms which is bothersome but tolerable Severe - Sign/symptom is hard to tolerate, may cause interference with activities of daily living and/or sleep Unbearable - Can't function, can't sleep, can't work, miserable, etc.

IV. Severity Based on Quality of Life Good Very Poor

0 1
General quality of li1e D = -3 =

10

Symptoms do not interfere with quality of life Mild - trivial or insignificant impact of symptoms on workk school and other activities

15

4-6 =

Moderate - noticeable, inconvenient or annoying is affected by symptoms at work, school, or curing other activities; performance at work or school d occasionally (once or twice a week): sleep is disturbed significantly once a week; social or recreational activities are occasionally avoided because of less enjoyment of these activities.

7-9 = Severe - significant, troublesome or disturbing impact on work, school or sleep; efficiency of performance at work or school is adversely affected to a significant degree or on a daily basis; work or school days missed because of symptoms and/or physician visits; sleep is disturbed significantly twice weekly or more; social and/or recreational activities often avoided and enjoyment of activities diminished significantly 10 = Very severe - sleep disturbance most nights; symptoms significantly impair work or school performance as well as social and/or recreational activities V. (A) Past Medications (including alternative medications) that you have used in the past and how effective were they? 1) Asthma Not Effective Very Effective

2 Other

(B) Present Medications 1) Asthma Not Effective Very Effective

2 Other

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APPENDIX IV A. Heimlich maneuver for asthma (HMM) described: The Self-Administered Heimlich Maneuver for Asthma (Should be practiced under physician's observation to ensure technique is correctly understood by participant) Method: Make a fist. Place the thumb side of the fist on the midline of your abdomen, halfway between bottom tip of the sternum and your navel. (Never press against the ribs.) Grasp your fist with your other hand. Breathe normally. Press the fist into your abdomen with smooth but firm upward pressure at the start of exhalation. You should experience exhalation of air and may cough up mucus. Repeat process twice more. Should abdominal discomfort occur and persist, see a physician immediately.

The Heimlich Maneuver for Asthma (Should be practiced under physician's observation to ensure technique is correctly understood by participant) Method: Make a fist. Place the thumb side of the fist on the midline of the patient's abdomen, halfway between bottom tip of the sternum and the navel. (Never press against the ribs.) Grasp your fist with your other hand. Subject should breathe normally. Press the fist into the subject's abdomen with smooth but firm upward pressure at the start of exhalation. Subject should experience exhalation of air and may cough up mucus. Repeat process twice more. Should abdominal discomfort occur and persist, see a physician immediately.

B. Modified Chest Massage (CMM) procedure described: The Inter-Costal Massage Method (Should be practiced under physician's observation to ensure technique is correctly understood by participant) Method: Position yourself behind the subject (either seated or standing). Start from the bottom of the rib cage and work your way up to the bottom of the shoulder blades. Using the fingertips of each hand gently, but firmly stroke outward from the spine, parallel to the ribs, to the outer limits of the shoulder blades. Repeat process twice more.

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APPENDIX V References: I. National Center for Health Statistics: National Health Interview Survey, 1994, DHHS Pub. No. (PHS) 95-1521 (Hyattsville, MD: National Center for Health Statistics, '23 2 CDC. MMWR Report: 47(47); 1022-1025, December 04, 1998 3. CDC. National Center for Health Statistics Fact sheet of 5 October 2001 found at vwAv.cdc.gov/nchs/products/pubs/pubd/hestats/asthma/asthma.htm. 4. Weiss KB, Gergen PJ, and Hodgson TA: An Economic Evaluation of asthma in the United States. N Eng J Med 1992; 326:862-866 5. Horwitz RJ, Busse WW; Inflammation and asthma. Clin Chest Med 1995;16:583620 6. Kay AB: Asthma and inflammation. J Allergy Clin Immunol 1991 ;87:893-911 7. Heimlich HJ, Hoffmann KA, Canestri FR: Food-Choking and Drowning Deaths Prevented by External Subdiaphragmatic Compression. Ann Thoracic Surg 1975; 20(2):188-195 8. Martin J, Powell E, Shore S, Emrich J, Engel LA. The role of respiratory muscles in the hyperinflation of bronchial asthma. Am Rev Respir Dis 1983 Mar 121(3) 441-47 9. Heimlich HJ, Patrick EA; The Heimlich maneuver - Best technique for saving any choking victim's life. Postgrad Med 1990; 87(6): 38-53 10. Heimlich, HJ, Heimlich, J. How the Heimlich Maneuver Helps Asthma Victims. Allergy Hotline 1997;6(2):1,5 I I . Koop CE: The Heimlich maneuver. J US Pub Health Serv Public Health Reports. 1985; 100(6): 557 12. Winstead-Fry P, Kijek J. An integrative review and meta-analysis of therapeutic touch research. Altern Ther Health Med 1999 Nov; 5(6): 58-67 13. Keller E, BzdekVM. Effects of therapeutic touch on tension headache pain. Nurs Res 1986 Mar-Apr;35(2) 101-06

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Original Message From: "Charles Edwards" <cedwards@snnbeach.net> To: <chaarls3pi^r 1 ,::.et> Sent: Sunday, September 08, 2002 3:32 PM Subject: Communication re: shipment and project

Dear Charles We have just returned from 2 weeks in the USA, one being spent organising business matters and settling in son Andre at the U of Michigan at Ann Arbor where he enrolled to study Act. Science. I have read your e-mails to Livvy. and sent an e-mail to him requesting an idea of their intentions. As of last month, he changed jobs and commenced

mailbox:///C

WrNDOWS/Application%20Data/Mozilla/Profiles/def...

full time employment with the University as a locturer and is no longer working as Polyclinic Consultant. I am interested from the point of view of whether the supplies will be coming, i.e not prying into the Rotary's [direct] business. One of the 3 paeditricians at my office is also an allergist and is exceedingly interested in doing the Heimlich manoevre study jointly with me. We have drawn up a pilot protocol. It would have to be approved by the Ministry of Health's Ethics committee. It would be most delightful to meet Dr Heimlich. I will await further correspondence with yourself and Livvy as to whether the Rotary S will accept to do the project and accept the container with appropriate finance and shipping arrangements etc. Anne.

mailbox:///C|/WINDOWS/Applicat

Subject: Re: Communication re: shipment and project From: "Charles Pierce" <charles@piercel .net> Date: Mon, 9 Sep 2002 15:06:55 -0400 To: "Charles Edwards" <cedwards@sunbeach.net> CC: "Henry J. Heimlich, MD" <heimlich@iglou.com>, "Ute Papke" <utemunic@one.net>
Thank you for your note. Yes, South remains slow at responding. Since I wrote that, I have spoken to the good Dr. Forde on the phone and have sent the inventory list to the current director of Community Service. What I have asked for is only some help to get the materials (Boxes) from Miami to Barbados. Our budget for World Community Service projects is not as it should be. We still may be able to get help but do not know yet for sure. There is always the way it came last year but the Louisville Club was very demanding in red tape if you recall. If South cannot get help from BIWI or someone, we can still go through the Louisville club One of the things I asked was if they wanted and needed what we have to send. This is why I enclosed the inventory list and also why I copied you. Livy assured me that the material was wanted. I ask you the same question and, in addition, to help me add more items to complete the second pallet. Can you give me a "wish list" of supplies, equipment etc that would be of great help / need and are welcome. This material is quite separate from the World Community Service (WCS) project also sent a few months ago which had new equipment for aerosol therapy for each hospital ward and the community clinics. This WCS project also included equipment (Spirometers etc) for the asthma study using the Heimlich maneuver. Incidentally, I am pleased that you remain interested in this study and will be glad to assist you with the protocol details, ICF or whatever else. This stuff is what I do at the Cincinnati Children's at this time. Talk to you again. Best regards, Charles.

************************************************************* Charles H. Pierce, MSc, MD, PhD Associate Director, Clinical Trials Office &

Phone: 513 681 4084, Fax 513 681 4094 Email: Charles^: ercel.net Personal slte: htup://Dr.Piercel.net Consultant Site: www.pmc1.org
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Subject: Asthma Study in Barbados From: "Charles Pierce" <charles@piercel.net> Date: Mon, 9 Sep 2002 14:35:34 -0400 To: "Henry J. Heimlich, MD" <heimlich@iglou.com> Henry, Just heard from Anne St. John, who is the head of Pediatrics at the Queen Elizabeth Hospital in Bridgetown, Barbados. Her note was in response to a note I sent to Dr. Livi Forde who is this years President at the Rotary Club of Barbados South about the stuff we have for them at our Reach program warehouse. We have two pallets of medical equipment mostly pediatric stuff. She is interested in getting it but "South" is slow in responding in general. What she went on to say was" "One of the 3 paeditricians at my office is also an allergist and is exceedingly interested in doing the Heimlich manoevre study jointly with me. We have drawn up a pilot protocol. It would have to be approved by the Ministry of Health's Ethics committee. It would be most delightful to meet Dr Heimlich." I had again mentioned the WCS project which has been in their hands and was approved by "South's" last years board. In that project we included the draft protocol which I send directly to Dr. St. John. She and I met last March and she was interested and was going to look for some funding help for a coordinator type nurse. I told her that there might be enough money in the project to help but that I needed "South's" portion to request our districts matching funds etc. In my note to Dr. Forde, I again mentioned your willingness to come down there to give a talk or two which, because of your name / fame / reputation could be a fund raiser for them. Talk to you about this again. Charles. ************************************************************* Charles H. Pierce, MSc, MD, PhD Associate Director, Clinical Trials Office & Chairman, Human Research Compliance Committee Cincinnati Children's Hospital Medical Center Phone: 513 681 4084, Fax 513 681 4094 Email: Charles@Pierce1.net Personal Site: http://Dr.Pierce1.net Consultant Site: www.pmci.org *************************************************************

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subject: Heimlich Maneuver study From: "Charles Pierce" <charles@piercel.net> Date: Mon. 16 Dec 2002 21:23:53 -0500 To: Henry J. Heimlich, MD \(Henry J. Heimlich, MD\)" <heimlich@iglou.com>
Hank, Have heard from Anne St. John, MD who is the head of the Department of Pediatrics at the Queen E izabeth Hospital in Barbados. . I do not know what will happen to the WCS Matching grant application to help asthma in Barbados but Anne told me that (and I quote) "one of the three paeds at my office is also an allergist and is exceedingly interested in doing the Heimlich Maneuver study jointly with me." "We have drawn up a pilot protocol." She will have top get it approved by the Ministry of health's ethics committee which I assume is under way. She also would be "delighted" to meet you when you (we) go down there. Wonder if a Carl Miller grant request would be in order? Hmmmm. I will ask her for a copy of the protocol. Maybe I can help her by getting an informed consent drafted as we have someone who does that in our office. Heard that you met one of my friends recently. Dr. Sander Vinks is just an excellent scientist / pharmacokineticist / Clinical Pharmacologist. Talk to you soon. Best as always, Charles ************************************************************** Charles H. Pierce, MD, PhD V. P. North American Medical Affairs Harrison Clinical Research Group Email: Charles.Pierce@Harrison-cro.com Phone: 888 604 7476 Web Site: www.HarrisonClinical.com Associate Director, Clinical Trails Office Cincinnati Childrens Hospital Medical Center Professor, Pharmaceutical Sciences University of Cincinnati College of Pharmacy 5563 Regimental Place Cincinnati, Ohio 45239 Phone: 513 681 4084 Fax: 513 681 4094 Email: Charles@Pierce1.net URL: http://Dr.Pierce1.net *************************************************************

-.;-]

12/17/02 8:24 AM

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Subject: A favor From: "Charles Pierce" <Charles.Pierce@cchmc.org> Date: Mon, 24 Mar 2003 10:59:41 -0500 To: "Henry J. Heimlich, MD" <heimlich@iglou.com>
Hank, Have just found out that Dr. Walson, as my supervisor, is unable to have his letter to the Medical staff of the CCHMC couut. Would you be wililng to write a arief note regarding what tou kkow. Obvvously, ,ou would not nave observed me in practice but perhaps could comment on those personal attributes with which you are familiar. The letter is to the Cincinnati Children's medical staff office so that I may officially be on staff now that I have an Ohio medical license. I have attached a C-V, a short narrative Bio and the letter Dr. Sallee sent. This later will give you the address to which the letter goes Thanks, Charles

Charles H. Pierce, MD, PhD Associate Director, Clinical Trails Office Cincinnati Childrens Hospital Medical Center Professor, Pharmaceutical Sciences University of Cincinnati College of Pharmacy

saggar

Phone: 513 681 4084 or 636 0395

*************************************************

1 o: :

3/24/03 12:39 PM

April 2, 2003

HEIMUCH INSTITUTE
311 STRAIGHT STREET CINCINNATI OHIO 45219 513-559-2391 FAX 513-559-2403 heimlich@iglou.com
www.heirrtichinstitute.ofg

Michelle Stultz, RN, CMSC, CPCS Director, Medical Staff Office Cincinnati Children's Hospital Medical Center 3333 Burnet Avenue Cincinnati, OH 45229 Re: Charles H. Pierce, M.D., Ph.D. Dear Ms. Stultz, I wish to strongly recommend that Dr. Pierce be appointed to the medical staff of Cincinnati Children's Hospital Medical Center . Since 1999,1 have had the pleasure of knowing Dr. Pierce professionally and personally. We first met as fellow Rotarians, where I soon learned his character can be measured by his volunteer work. He is involved in a Rotary program sending medical supplies and equipment to underprivileged countries. Charles' dedication is evident by the fact that he and his wife traveled to Nepal to determine what medical supplies were needed. He then arranged for two huge containers of them to be sent to Nepal, His expertise in the field of asthma is well established, as is his interest and knowledge of that condition. This is apparent in the list of invited presentations in his Curriculum Vitae. Dr. Pierce's position as Associate Director of the Clinical Trials office of your hospital indicates his reputation in other fields of medicine, as well. I highly endorse Dr. Charles H. Pierce as a member of your staff. He will surely bring honor to your institution. Please feel free to contact me if you desire further information.

Benefiting Humanity Through Health and Peace

President

Affiliated with Deaconeessssociations Inc.

-Original Messagee From: M. Anne St. John [maiito:mastj@sunbeach.net] Sent: Wednesday, June 04, 2003 9:53 PM To: Charles Pierce Cc: Livingston Forde; basilgf@caribnet.net Subject: Shipment Dear Charles The good news. The shipment has been located, however there is a large backlog of items to be cleared by the QEH's Supplies Dept. I have been told that since the QEH has been "on its own" after Ap 1st, and under a board of management, the Supplies Dep't has to clear its own items and has become overwhelmed with additional duties and responsibilities. The duty and charges for storage of the shipment are to the tune of $ 40,000. However a letter requesting a waiver will be sent by the QEH. I will let you know when the pallets actually arrive on the premises. Incidentally permission has come through for the Heimlich study to be done. Dr Stephen Feanny--a Paed, and allergist has been very interested in doing the study with me. We have identified a research nurse who is willing and has experience in doing paed. asthma studies. We just need to identify and source a spirometer. She has agreed to $400 bds [$200] per week to see and follow the patients. We thought that it was better to have a control gropu so we will have a total of 30 study and 30 control. We plan to commence the practical study in the end of July. Did you heard anything more from Rotary South on a financial commitment? How would this fit in with a visit from Dr Heimlich and other plans you

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6/5/03 10:02 AM

mailbox:///C|/WINDOWS/Application%20Data/Mozilla/Profiles/defau... had?

Regards Anne.

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Subject: FW: Shipment From: "Charles Pierce" <charles@piercel.net> Date: Thu, 5 Jim 2003 09:01:03 -0400 To: "Henry J. Heimlich, MD \(HenryJ. Heimlich, MD\)" <heimlich@iglou.com>
Hank, This is for your information. This is great news for the study as it has now passed through and been approved by the Barbados IRB. What she is referring to is a WCS grant I proposed many months ago which has not been followed up on by the Rotary Club of Barbados South. In that grant, I had included a KoKo spirometer and other equipment for the study. These grants, as you know, do not pay for people. If only we could get them a spirometer. I am puzzled and surprised by that turn of events as I know many members of that club personally and the current president is not only a friend but a physician who I know personally favors the project. This group has pushed "procrastination" to a new level. Have attached the grant request as a reminder. I think you have seen this before. Best regards, Charles ********************************************** Charles H. Pierce, MD, PhD Phone: 513 681 4084 or 636 0395 Email: Charles@Pierce1.net URL: http://Dr.Pierce1.net *********************************************

Original Message From: M. Anne St. John [mailto:mastj@sunbeach.net] Sent: Tuesday, June 17, 2003 9:33 PM To: Charles Pierce Subject: Spirometer Dear Charles I have met with the research nurse and Stephen Feanny and we plan to begin out study in mid July latest August 1st week. With his wide experience with asthma and testing in children (worked at the Hosp. For Sick Children in Toronto) , Stephen prefers the Koko Spirometer. However acquisition of the Spirometer is still a challenge. I have a few dollars left from a previous research project which could go towards to Koko Spirometer. I have not heard anything from Livi. The container has still not been cleared [ I'm pressurising them daily] , however we have a stock of Wright P F meters in the department which can be used. Would it be too much trouble to ask you to find out how much would it be to purchase and have a Koko Spirometer sent here by Fedex? Even a used one would be acceptable at this stage. Regards Anne.

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Original Message From: M. Anne St. John [mailto:maatj@susbeach.net] Sent: Tuesday, June 17, 2003 9:35 PM To: Charles Pierce Subject: Visit Dear Charles I agree with you that Dr Heimlich's visit would be better planned for towards the end of the study i.e next year so as not to influence patient's results. Anne.

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Subject: RE: Spirometer From: "Charles Pierce" <charles@piercel.net> Date: Wed, 18 Jun 2003 11:16:49-0400 To: "'M. Anne St. John"' <mastj@sunbeach.net> CC: "Livi Forde, MB, DM " <DocLAForde@hotmail.com>, "Henry Fraser, MD, PhD" <HFraser@sunbeach.net>, "Henry J. Heimlich, MD" <heimlich@iglou.com>, "Ute Papke <Utemunich@aol.com>
Anne, Pleased to hear that the Asthma study employing the modified Heimlich maneuver is on track - even if the shipment to the QEH sent 4 months ago is not. Hmmmm, Murphy's law is even valid in Barbados. We will look into finding and shipping a another. I am sorry that South has not responded We have the offer of some help from the Heimlich that our club or district can fill in the rest. attached? spirometer one way or or appears willing to help. Institute and it may be Should we proceed on the

I am very familiar with the KoKo but only the adult versions. Are these appropriate for a Pediatric population? Should we look into the pediatric version? It may be that Flow data from kids will be adequate to demonstrate the improvement in these patients. The main variables will be number of ED visits, attacks, hospitalizations and things like that. What do you think? Hope the shipment comes through soon. ********************************************** Charles H. Pierce, MD, PhD Phone: 513 681 4084 or 636 0395 Email: C h a r l e s @ P i e r c e l . n e t URL: ht tp = /7Dr". PTePceTTnet *********************************************
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Best regards,

Charles

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Subject: FW: Visit From: "Charles Pierce" <charles@piercel .net> Date: Wed, 18 Jim 2003 10:52:54 -0400 To: "Henry J. Heimlich, MD \(Henry J. Heimlich, MD\)" <heimlich@iglou.com>
Hank, For your information and the reply to my message on this topic which I copied you - I think ********************************************** Charles H. Pierce, MD, PhD Phone: 513 681 4084 or 636 0395 Email: Charles@Piercel.net URL: httpT/'/Dr.Piercel.net *********************************************

Original Message From: M. Anne St. John

[mailto:mastj@sunbeach.net]

Dear Charles I am writing to update you on the progress of our collaborative study. We have had a little hiccup in recruiting the number of patients (60 total [with controls] rather then 30 for study only). The statistician is to meet with us next week when she returns, I had given her the protocol to study and give an opinion. The only outstanding matter is the matter of funds to pay the research assistant/nurse--Mrs Howard. She is ideal and experienced in this type of research and has worked with the Barbados Asthma research Study in the past. My co-researcher Paed. Allergist & Immunologist Stephen Feanny has commenced her briefing and training. I do have a small amount of funds in a research account which I can borrow until it can be replaced. That would carry for a few weeks. However it is lodged in a hospital A/C and may prove difficult to mobilise for this purpose--knowing the bureaucracy. Can you tell me what arrangement can be made for sending the money here to pay the research Assistant? We estimate a cost of US $150 per session i.e per month. There may be a little more for miscellaneous e.g stationery, mouthpieces, etc. I can incorporate some of the blood tests as "routine" bloods, since patients are eligible to have some bloods done "free" once they come to the QEH. This will save on money. Regards Anne.

FW: Financing

Subject: FW: Financing From: "CPiercel" <charles@piercel.net> Date: Sat, 12 Jul 2003 20:51:37 -0400 To: "Henry J. Heimlich, MD" <heimlich@iglou.com>
Hank, Do you have any ideas on how we could help them? Charles ********************************************** Charles H. Pierce, MD, PhD Phone: 513 681 4084 Email: Charles@Piercel.net URL: http://Dr.Piercel.net Talk to you,

*****T^t^^^^^^^^*******************

Original Message From: M. Anne St. John [mailto:mastjO'unbeach.net] Sent: Monday, July 21, 2003 9:04 P M To: Charles Pierce Subject: Details needed Dear Charles We almost have everything ready to go and will begin in mid August. The research assistant/ nurse had located the patients and arrangements have been made for them to come on dates in Aug. for the initiation of 1). We are curious about the described the "modified Heimlich Manuevre" mentioned in the protocol. What exactly is the modification? We need to know asap. 2) What about the funding which was mentioned from your end? It is needed to pay the research assistant. She has agreed to work for very small stipend per session. Regards Anne.

RE: Details needed

Subject: RE: Details needed From: "Charles Pierce" <charles@piercel.net> Date: Mon, 21 Jul 2003 21:42:24 -0400 To: "M. Anne St. john"' <mastj@sunbeach.net> CC: "Henry J. Heimlicti, MD" <heimlich@iglou.com>
Anne, We are excited that you are close to starting. The "modified" Heimlich is described in the Appendix of our study for up here. Will attache this appendix. You may note that the "modification" is only that it is performed with less vigor. It is done slower but not less forceful or complete Regarding some funding, what was mentioned earlier was that we may be able to come up with what was thought to be part of the money for the PFT equipment. As you were fortunate (Lucky you said) to be able to find a KoKo I let this slip. I wilj speak_to_smme_of_the_gang up here and_jsee_ if_ w_e. -CafmoE-heTp-a bit-but^one of the rules of Rotary WCS grants and such is that personnel are not included. Easier to get money for equipment and supplies than for people like nurses. From your and my point of view as researchers, this doesn't make a lot of sense. I will see if I can get some for this project. That said, however, I will see what we can do. Will you remind me again how much is needed per visit and for the whole study? Thanks. Did the statistician come up with a number and did you decide on how to handle the controls? Best, Have you received the supplies and goods? Charles Is the material helpful?

**********************************************
Charles H. P i e r c e , MD, PhD

Phone: 513 681 4084 Fax: 513 681 4094 Email: C h a r l e s @ P i e r c e l . n e t - -URL-T h t t p - T / T P r T P i e r c e l . n f t ~ *********************************************

Original Message From: M, Anne St. John [mailto:nastj?sunbeach.net] Sent: Wednesday, July 23, 2003 5:58 PM To: Charles Pierce Subject: Re: Details needed Dear Charles I have calculated that we would need to have USD $200 per month to complete the study. That would total 13 X 200= USD $2600. The supplies which arrived are being issued to the various areas. The QEH's supplies officer has opened a number of the boxes and issued items to where I indicated that they should go. I will update you when everyone has received their respective items. Regards Anne.

R . : r v . : n-.eded

Subject: RE: Details needed From: "Charles Pierce" <charles@piercel.net> Date: Wed, 23 Jul 2003 20:53:30 -0400 To: "M. Anne St. John'" <mastj@sunbeach.net> CC: Henry J. Heimlich, MD" <heimlich@iglou.com> C e r t a i n l y no harm i s done by a s k i n g . Would you send me an e l e c t r o n i c copy of the p r o t o c o l you had approved so we can include i t in our r e q u e s t . As Dr. Heimlich i s a well known and well r e s p e c t e d member of our c l u b , we may have a chance seeing as the amount i s not insurmountable. Hank and I w i l l d i s c u s s t h i s with our clubs "funding people" and we w i l l see if t h i s i s p o s s i b l e . Best r e g a r d s , Charles
********************************************** Charles H. Pierce, MD, PhD Phone: 513 681 4084 Fax: 513 681 4094 Email: Charles@Piereel.net URL: http://Dr.Piercel.net

^^^^U********************************

FW: Details "eeded

Subject: FW: Details needed From: "Charles Pierce" <charles@piercel.net> Date: Wed, 23 Jul 2003 20:48:07 -0400 To: "Henry J. Heimlich, MD" <heimlich@iglou.com> Hank, The amount needed to do our study for a year seems hardly think. Thanks, Charles

********************************************** Charles H. Pierce, MD, PhD Phone: 513 681 4084 Fax: 513 681 4094 Email: Charles@Piercel.net URL: http://Dr.Piercel.net ********^************************************

RE: Details needed

Subject: RE: Details needed From: "Charles Pierce" <charles@piercel.net> Date: Thu, 24 Jul 2003 14:54:35 -0400 To: '"M. Anne St. John"' <mastj@sunbeach.net> CC: "Henry J. Heimlich, MD" <heimlich@iglou.com>, "Ute Papke " <Utemunich@aol.com> Anne, I have some really good news. Spoke to the chair of our allocations committee and the club has funds for this type of project. He implied that all I have to do is put in the request. He is one of my favorite guys in the club and this may be a factor but who cares. I will need to complete a grant request form which he is sending me this afternoon. Is there any involvement of the Rotary Club of Barbados South? This is not essential but just wondering. Need the copy of your study so I can either include it as an attachment or talk about it knowingly. Also need to know if there is anything else we should add. $2,600 US is not very much and I think that if I can make the case that we can get a bit more. Do you have spacers? Peak Flow meters? Diaries? ? I will apply for these funds without Dr. Heimlich at his suggestion as we do not want there to appear to be any conflict of interest seeing as the study bears his name. Hank again stated that his institute is willing to help if there is some needed item of device that will make the study easier for you. Best regards, Charles ********************************************** Charles H. Pierce, MD, PhD Phone: 513 681 4084 Fax: 513 681 4094 Email: Charles@Piercel.net URL: http://Dr.Piercel.net **********************-^^********************

Original Message From: M. Anne St. John [mailto:mastj@sunbeach.net] Sent: Thursday, July 24, 2003 8:56 PM To: Charles Pierce Subject: Re: Details of study Dear Charles It seems that your "strings" and connections are always good ones. I have cleared the matter of numbers with the statistician. She says that the 30 in each group is fine. We have looked into the costing in more detail and decided that a Max of $ UDS 5000 would be just fine to cover all expenses. I have not had any more input or communication from Rotary South re interest/ assisting with the project. The presidency changed recently, and Livi seemed relieved , especially since he had a mammoth task on hand and got his wish of accepting the first set of women to be inducted into his club--a first for B/dos. We are photocopying asthma diaries to be distributed. That would save on printing costs. I have attached the final draft protocol which is being used and respond with your comments. Regards Anne.

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A Prospective Historic Controlled Study on the Utility of Using The "Heimlich Maneuver for Asthma" (HMM) as an adjunct In the Management of Asthma in Children and Young Adults

This document is a confidential communication of the Department of Pediatrics of the Queen Elizabeth Hospital, Bridgetown, Barbados, Wl. The information contained herein will not be disclosed to others without written authority of the Department of Pediatrics except for the Institutional Review Board

Anne St.John, MB. BS. FRCPC, FAA Department of Pediatrics, Queen Elizabeth Hospital and Stephen Feanny MB. BS, FRCPC Paediatric Allergist, Queen Elizabeth Hospital Bridgetown, Barbados, West Indies

20 July 2003.

1. Introduction The problem of asthma on the island of Barbados is one of major proportions costing the Health Service an inordinate amount of money. The yearly average is more than 12,000 Emergency Room visits to treat patients in an asthmatic crisis and an eye-popping and rather alarming 12 (one per month) deaths. This figure is staggeringly high compared to that of North America especially when "emergency" treatment (via simple aerosol) or the "Heimlich Maneuver for Asthma" could and should be available or used either at home for the severe asthmatic or at local community clinics. Asthma is a worldwide problem of increasingly importance with an extremely high prevalence on the island nation of Barbados, especially in the Paediatric population with associated deaths. Deaths should be totally preventable, which is the reason for this project. Asthma is unique as a medical condition, in that it is both an episodic illness and a chronic one requiring long-term care and stabilization. During the episodic asthmatic attacks patients experience airway hunger, anxiety and are desperate for immediate relief. They then seek immediate medical care at the Asthma Bay of the Queen Elizabeth Hospital. This facility is open 24 hours a day and patients are allowed to enter the Bay once they inform the triage nurse of their problem. It is available free of cost to all citizens of Barbados. Over the years, however, there has been a tremendous rise in the number of patients seeking care at this Asthma Bay. In 1978 there were 2,642 patients and this rose to 9,781 in 1998. This four-fold rise needs not only an explanation but a management plan that will reduce a number of visits. In trying to seek why certain patients are more susceptible to asthma than others, Barbados has an ongoing collaborative study on the Genetics of Asthma with Johns Hopkins Allergy and Asthma Institute in the United States (Naidu, Barnes et al). It is expected that this study will assist in identifying genes that are specifically linked with asthma. At the same time, however, a better system of asthma care has to be offered to the national population suffering from this condition. A recent survey (Salazar, Naidu) done in the Asthma Bay showed that after an acute attack and treatment in the Asthma Bay only 38% of patients reported to have follow up treatment by their primary care physician. Just as striking from the survey was that 20% of these patients had two (2) attacks within the last 3 months, 17% three (3) attacks, 8% four (4) attacks, 7% five (5) attacks and 5% greater than six (6) attacks within the last 3 months. This should be no surprise with the current inadequate follow up care mentioned above. Asthma attacks, which consist of prolonged spells of dyspnea and shortness of breath that can be fatal, occur when muscles surrounding the airways contract, narrowing the air passages, the linings of which are chronically swollen and inflamed 1 Mucus fills the airway and acts as a valve, i.e., when the asthmatic breathes in, the airway opens up and air slides around mucous plugs. On exhaling, mucous plugs clog narrowed airways and air cannot get out. Trapped air distends the lungs, making both inhalation and exhalation difficult. The term "attack" refers,

in this document, to a rather sudden increase in the symptoms we know as "Asthma". The "Heimlich Maneuver for Asthma" consists of applying pressure to the upper abdomen, which has the effect of pressing the diaphragm upward. The upward movement of the diaphragm diminishes the volume of the chest cavity, thereby compressing the lungs uniformly, resulting in a flow of air out of the alveoli through the tracheobronchia! tree toward the mouth. The airflow transmits kinetic energy to foreign substances, solid or liquid (food, water, mucus), dislodging the obstruction.2 Tests on ten volunteers demonstrated the Heimlich maneuver expels a volume of 940 cc (0.94 L) of air from the lungs in approximately 1/4 of a second. The average flow rate is 205 liters per minute.2 This airflow was considered to be sufficient to carry foreign substances out of the airway, and this has proven to be accurate. Similar application of Heimlich maneuver to drowning victims causes a flow of water from the lungs, which gushes out of the mouth. The physical principle that enables the Maneuver to expel foreign substances from the airway is energy, not pressure. Extensive studies show there is minimal intrapulmonary pressure increase. Kinetic energy of the airflow, the energy of motion, is transmitted to a foreign substance ejecting it from the airway.3 Kinetic energy is defined as the energy of a body or system with respect to the motion of the body or of the particles in the system. Airflow from the lungs to the mouth, as created by compression of the lungs, is a form of kinetic energy. The kinetic energy provided by airflow is equally effective whether the foreign substance is large enough to obstruct the airway or is a small object or fluid such as water or mucous. Anecdotal reports of Heimlich maneuvers having a beneficial effect in asthma have appeared in recent years.4 Asthmatics report acute attacks stop immediately after the Heimlich maneuver is used. The victim is reportedly able to breathe normally. When the Heimlich maneuver is used prophylactically, there is a reported reduction in the number of attacks, and a general improvement including a lessening need for medications. As a working hypothesis, these observations are explainable by considering mucous, which prevent exhalation in an asthma attack, to be analogous to foreign bodies blocking small airways. Application of the Heimlich maneuver to an asthmatic expels trapped air, which generates airflow that expels the mucus, allowing the victim to breathe. Mucous plugs are semi-liquid, smaller and lighter than a food object, which causes choking. It is postulated, therefore, that the "Heimlich Maneuver for Asthma" (HMM), performed in a slow and steady manner, will clear the airway and end the asthma attack. In 1985, Dr. C. Everett Koop, then Surgeon General of the United States, advised, "The Heimlich Maneuver is safe, effective, and easily mastered by the average person. It can be performed on children and even on one's self."5 Asthma patients can, therefore, treat their own attacks or have someone else perform the HMM on them. The maneuver is to be done more gently on asthma patients, particularly children, than on choking or drowning victims.

To determine whether the "Heimlich Maneuver for Asthma" (HMM) has a significant and/or lasting effect on asthma requires a careful prospective study. The modification of the universally accepted Heimlich maneuver to be used in the present study is that pressing on the upper abdomen be done in a slow steady manner.

2. Study Objective / Significance To determine the role of the "Heimlich Maneuver for Asthma" (HMM), which is a modification of the usual maneuver only in being done with less vigor, in breaking an attack, reducing the frequency of attacks and reducing the requirement for rescue medications in asthma by the following: 2.1 2.2 2.3 2.4 Use of the HMM to relieve the symptoms of an acute asthmatic attack. Use of the HMM prophylactically to reduce the frequency of asthma attacks . To assess the change in the patient's physician use of medications following regular HMM use. To assess the ease of teaching asthmatics to use the HMM on themselves and/or the ease of teaching parents/guardians in the use of the HMM

3. Summary of Study Design / Research Plan 3.1 Overview: Referred patients will be assessed as to the severity of their symptoms of asthma and the number of times in the prior 6 months that they have had what they call an "attack" of their asthma 3.1.2 The patient is then to be screened to insure that their history and present condition comply with the Inclusion / Exclusion criteria established 3.1.3 Where applicable, meaning that the patient has the psychomotor skills and can be taught the procedure, a pulmonary function test will be performed using a standard spirometer. Each patient will also be instructed regarding to completion of the diary and the performance of peak flows with the provided peak flow meters 3.1.4 Each patient and the patient's parents or guardian, when applicable, will be taught how and when to perform the "Heimlich Maneuver for Asthma" (HMM) so that it is clear that this procedure can be done in a correct manner. ' " 3.1.5 Each patient will be given a diary and instructions as to how it is to be completed and the reasoning behind the questions asked. The patient will be encouraged to share this with her/his primary care giver. 3.1.6 Each patient will be asked to perform a Peak flow determination before and after a HMM twice a week on non-consecutive days. It will be recommended that at least one of these be an early morning event. 3.1.7 The patient will be instructed to follow the Asthma Action Plan recommended by her/his personal physician without delay but with the following modifications: When feasible, perform (or have performed) the HMM when an "attack" or worsening of symptoms is developing and recording this in the diary. When the inhaler medication is prescribed "prn" or as "rescue therapy" and is needed, the patient or parent is asked to perform the HMM first with a PFR before and after if this can be done. 3.1.1

3.2
Event

Flow sheet of study:

Screening M1 M2 M3 M4 M6 M8 M10 M12 Final*

Informed Consent Inclusion/Exclusion criteria History/demographics Complete physical exam Pulmonary Function Testing 1 Peak Flow Rate (PEFR) * Diary training / Evaluation Clinical severity score J Safety Labs (Chem,CBC, UA) Adverse Events

X X X X X1 X2 X

xa
X X

X X X X

X X X X

X X X X

X X X X

X X X X X

X X X X

X X X X

X X X X X

X X X X X X

* The "final visit" will be within 1 month of fhe ffnal visit 1 Pulmonary function will be performed on patients demonstrating the psychomotor skills required to perform the test correctly. 2 Peak flow rates (PEFR) will be determined at the study visits as demonstration that the patient knows and is comfortable with the procedure 3 The clinical severity score will be determined using the analog scales as per appendix II 3.3 Questions to be answered: 3.3.1 3.3.2 3.3.3 Is HMM an effective procedure for the emergency relief of the symptoms of an attack (acute exacerbation) of the symptoms of asthma? Is HMM an effective temporary measure for the relief of the symptoms and improvement in pulmonary function (PEFR) in patients with asthma? Does HMM reduce the number of acute attacks of asthma from that which the patient had experienced in the 6 months prior to the study and in the first two study visits? Does HMM reduce the reliance on regular or rescue medications? Does HMM reduce the need for prn medications? Does HMM enable the patient's physician to reduce the medical regimen? Does the use of HMM reduce the number of missed school days? Does the use of HMM reduce the number of ED visits _,

3.3.4 3.3.5 3.3.6 3.3.7 3.3.8

4. Investigator and Facilities 4.1 Principal Investigator: Anne St. John, MB, BS, FRCPC, FAAP Department of Pediatrics Associate Lecturer, Shool of Clinical Medicine and Research Queen Elizabeth Hospital, Bridgetown, Barbados

5. Subject Selection 5.1 Patients

60 patients with 30 to serve as controls who meet the criteria of moderate persistent up to severe asthma and who/ whose parents voluntarily give written consent to the therapy will be used in this study 5.2 Inclusion Criteria 5.2.1 Patients with a minimum of a six month history of asthma requiring regular medical therapy of any type Diagnosis of Mild Persistent asthma to Severe asthma according to the accepted criteria for this diagnosis (Appendix II) Patients greater than 6 years of age but less that 16 years of age of either sex In general good health except for the diagnosis of bronchial asthma. Have the psychomotor skills to learn and perform pulmonary function testing and/or peak flow rate measurements. Willing to keep a diary of medication use and PEFR determinations as recommended. Have no medically or clinically significant illness of the lungs or abdominal organs which in the view of the Principal Investigator might place the patient at any risk Patients who voluntarily assent to be on this study and whose parents will consent for their child to be on this study

5.2.2

5.2.3

5.2.4 5.2.5

5.2.6

5.2.7

5.2.8 5.3

Exclusion Criteria 5.3.1 History of clinically significant renal, hepatic, endocrine, oncologic, cardiovascular disease, or any other condition, which in the opinion of the Investigator, would jeopardize the safety of the patient or impact on the validity of the study results History of severe, continuous or intractable asthma History of smoking, Chronic bronchitis, emphysema or Cystic Fibrosis or any other pulmonary disease Recent surgery especially abdominal and thoracic surgery History of conditions where the HMM is contraindicated such as ulcers, abdominal hernias, diaphragmatic hernias, artificial heart valves, abdominal aneurysm and pregnancy. Unable or unwilling to give voluntary informed consent / assent or whose parents do not freely consent for their child to participate in this study.

5.3.2 5.3.3

5.3.4 5.3.5

5.3.6

Screening procedures

The Principal Investigator or her/his designee will assess the following screening procedures at the time of screening: 6.1 Medical History A complete medical history, including a detailed list of medications taken (Drug dose, frequency of use, start and stop date) for all medications taken since the diagnosis of asthma was made. In addition, other prescription medication used in the month prior to the start of the study. For females of child bearing potential, the birth control methods used will be assessed. The documentation of a minimum of a six month history of asthma requiring the use of asthma medications prescribed on a regular or pm basis and used appropriately by the patient will be determined prior to proceeding to the next step. 6.2 Physical Examination 6.2.1 6.2.2 Height (in cm) and weight (in Kg). Vital signs while seated (respiratory rate, heart rate, blood pressure and temperature). Pulmonary function tests including FVC, FEV1; FEF 25-75, and the various calculations made from these tests to be done on patients posing the psychomotor skills required for a standard PFT. Peak Flow rate testing (PEFR) using a Wrights Flowmeter plus PEFR using the device the patient will use while ambulatory

6.2.3

6.2.4

6.3

Clinical Laboratory tests: Results of laboratory tests are to be assessed at the investigators option and those beyond the reference ranges accepted for the study only if the Investigator determines that there is no risk to the patient should they have the HMM procedure done as per the protocol. 6.3.1 Hematology: Hemoglobin, Hematocrit, WBC, differential eosinophil count, RBC, platelet count including an

6.3.2

Serum Chemistry: Alkaline phosphatase, ALT, AST, LDH, Total bilirubin, Urea nitrogen, creatinine, glucose, total protein, and electrolytes'(Na, K, Cl) Urinalysis: Macroscopic (dipstick), pH, specific gravity. Microscopic examination done if protein, nitrates or blood are present on the macroscopic exam Serum pregnancy test in female patients of childbearing potential

6.3.3

6.3.4

6.4

Informed Consent All prospective patients will have the study explained by a member of the research team. The nature of the HMM procedure will also be explained along with potential hazards and possible adverse reactions.

Prior to the initiation of the study, acknowledgement of the receipt of this information and the subjects freely tendered offer to participate will be obtained in writing from each subject in the study. Those patients under the age of consent and over the age of 6 will voluntarily assent to the study under the same circumstances and their parent or legal guardian will sign the consent form indicating that they have given permission for their child to be on the study. 7. Prescribed Medications 7.1 Current medications will be documented as to name, dose, frequency and duration of therapy: 7.1.1 The patient will provide assurance that they understand and take their asthma medications correctly. Additional concomitant medications will also be documented and recorded.

7.1.2

8. Study Conduct 8.1 Subject Assignment 8.1.1 Subjects will be placed on the study after random selection after A & E visits from the A & E database and parent/guardians agree to consider being in the study.

8.2 Visit Procedures At the initial visit the HMM and protocol w ill be explained to study patients and baseline bloods and parameters will be taken. At the inital visit control patients will be briefed without the HMM being discussed. 8.2.1 On each visit the patient or parent will complete the "clinical Severity" questionnaire, and a brief questionnaire to affirm that the inclusion / exclusion criteria have not been compromised. In addition, each patient will undergo a brief assessment and be questioned about any adverse events since the last visit Each patient will be asked to demonstrate her/his ability to perform the Peak Flow measurements. The diary of each patient will be reviewed for accuracy and completeness.

8.2.2 8.2.3 8.2.4

8.3 Dietary / Meals The subjects will be asked to maintain their normal diet and eating habits including their normal cola/coffee/caffeine consumption during the study period. 8.4 Drug Administration All subjects will take their medications as prescribed by their primary physician as prescribed and required. 8.5 Safety Assessments 8.5.1 Vital signs (Blood Pressure, heart rate and temperature) will be monitored on each of the 12 visits

8.5.2

Adverse Events will be monitored throughout the study. Subjects will be instructed to inform the study physician and/or the study nurse of any untoward, unusual or adverse events that have occurred since the preceding visit.

9. Adverse Events 9.1 All adverse events occurring during this study will be recorded on the case report form provided. The investigator will review each event and assess its relationship to study events as to whether the event is unrelated, unlikely to be related, possibly related, probably related, or almost certainly related to the study procedure. 9.2 Each sign, symptom, or other adverse event will be graded on a 3-point severity (mild, moderate, or severe) and will be recorded as to the date and time of onset, time relationship to the injection of the test agent, the duration of the event and the outcome of each event. This information will also be recorded on the case report form. 9.3 The definitions for rating severity will be the following: Mild Moderate Severe Easily tolerated and does not interfere with daily activity Interferes with daily activity but subject still able to function Incapacitating and requires medical intervention

9.4 Serious Adverse Events: If any of the above adverse events are "serious" as defined by the FDA CFR: 21, special procedures will be followed. All serious Adverse Events (SAE's) will immediately be reported by telephone to the sponsor, followed by a written report within 5 calendar days, whether or not the SAE is deemed study related. All SAE reporting will adhere to the FDA reporting regulations. The IRB will also be notified concerning any SAE. 9.5 The definition of a Serious Adverse Event (SAE) is the following 1. Death 2. Life threatening events 3. Events which are permanently disabling or incapacitating 4. Events requiring hospitalization or prolonged hospitalization 5. Any congenital anomaly, cancer, or drug overdose 9.6 Adverse Events, whether serious or non-serious, will be followed to their resolution regardless of whether the subjects are still participating in the study. Where appropriate, medical tests and examinations will be performed to document the resolution of the event(s). The outcome may be classified as recovered, persists (a chronic condition is diagnosed), died, or lost to follow-up.

10. Removal of subjects from the Study 10.1 Freedom to withdraw: All subjects and their legal guardian (when applicable) will be advised that they are free to withdraw from the study at any time. The Investigator may remove a subject from this study if he feels this action is in the best interest of the subject. When a subject withdraws from the study, all of the safety data normally required at the end of the study should be obtained it possible.

10.2 Adverse Events: Subjects experiencing adverse reactions should be followed until the reaction has resolved. The investigator will administer appropriate supportive and/or definitive therapy throughout the study or insure that the patients physician has been notified and she/he agrees to manage the event. 10.3 Replacing Subjects: Subjects withdrawing or removed from the study for any reason will be replaced 11. Pharmacokinetic and Statistical methods Changes in all clinical and biochemical markers will be summarized using descriptive statistics. In addition, a longitudinal assessment of the PFT's, Peak flow measurements, Medication requirements and number and duration of asthma attacks will be made.

12. Study Report 12.1 Case report Forms will be provided for each subject. The investigator will assure that all entries onto these forms is complete and accurate. 13. General 13.1 Protocol deviations / Amendments: Deviations from this protocol will not be permitted, except as a medical emergency as determined by the Investigator. If deviations are required to protect the subject, the Investigator will notify the sponsor immediately, and submit documentation to the IRB within 10 working days The Investigator can initiate amendments to the protocol. If agreement is reached concerning the need for a modification, a formal amendment should be made to the protocol. The IRB must approve all revisions and/or amendments to this protocol in writing. 13.2 Institutional Review Board: This protocol, informed consent, assent form, and any amendments to the protocol will be reviewed by the IRB prior to initiation. The study will not be initiated without the approval of the IRB, whose operations must be in compliance with CFR 56; Title 21. Written notice that the protocol and informed consent / assent forms* have been reviewed and approved by the IRB will be submitted to the Investigator and the Sponsor prior to study initiation. 13.3 Study Termination: The Investigator resen/es the right to discontinue this study for safety reasons at any time. This is in collaboration with the sponsor 13.4 Study Records: All records and documents pertaining to the study will be maintained by the Investigator, and will be available for inspection by the sponsor or the Food and Drug Administration at any time.

10

10.2 Adverse Events: Subjects experiencing adverse reactions should be followed until the reaction has resolved. The investigator will administer appropriate supportive and/or definitive therapy throughout the study or insure that the patients physician has been notified and she/he agrees to manage the event. 10.3 Replacing Subjects: Subjects withdrawing or removed from the study for any reason will be replaced 11. Pharmacokinetic and Statistical methods Changes in all clinical and biochemical markers will be summarized using descriptive statistics. In addition, a longitudinal assessment of the PFT's, Peak flow measurements, Medication requirements and number and duration of asthma attacks will be made.

12. Study Report 12.1 Case report Forms will be provided for each subject. The investigator will assure that all entries onto these forms is complete and accurate. 13. General 13.1 Protocol deviations / Amendments: Deviations from this protocol will not be permitted, except as a medical emergency as determined by the Investigator. If deviations are required to protect the subject, the Investigator will notify the sponsor immediately, and submit documentation to the IRB within 10 working days The Investigator can initiate amendments to the protocol. If agreement is reached concerning the need for a modification, a formal amendment should be made to the protocol. The IRB must approve all revisions and/or amendments to this protocol in writing. 13.2 Institutional Review Board: This protocol, informed consent, assent form, and any amendments to the protocol will be reviewed by the IRB prior to initiation. The study will not be initiated without the approval of the IRB, whose operations must be in compliance with CFR 56; Title 21. Written notice that the protocol and informed consent / assent form! have been reviewed and approved by the IRB will be submitted to the Investigator and the Sponsor prior to study initiation. 13.3 Study Termination: The Investigator reserves the right to discontinue this study for safety reasons at any time. This is in collaboration with the sponsor 13.4 Study Records: All records and documents pertaining to the study will be maintained by the investigator, and will be available for inspection by the sponsor or the Food and Drug Administration at any time.

10

APPENDIX I
Clinical Characteristics of Asthma MILD Intermittent FEV1 or PEFR > 80% of predicted FEF variability < 20% Exacerbation's are brief Symptoms < 2x1 week Nighttime symptoms < 2x/ month asymptomatic between exacerbations

MILD Persistent FEV! or PEFR > 80% predicted FEF variability between 20% and 30% Exacerbations may affect activity Symptoms > 2x1 week BUT < 1x/ day Nighttime symptoms > 2x1 month medication use prn

MODERATE Persistent FEV, and PEFR > 60% and < 80% predicted FEF variability > 30% Exacerbations > 2x1 week and activity is affected Symptoms are daily Nighttime symptoms > 1x/week Require daily use of short acting beta agonists SEVERE Persistent F E ^ and PEFR < 60% predicted FEF variability 30% Exacerbations frequent Symptoms are continuous Nighttime symptoms frequent Activity is limited by the disease

11

APPENDIX II
"Heimlich Maneuver for Asthma" Physician Record Name of Patient: Date of Examination: _ Height: Weight: / / Race: Black Hospital # Physician: Age: White Sex: M Oriental Other ,F DOB:

Historical data: 1. Age when fist diagnosed with asthma? 2. Number of Emergency room visits for asthma in the last 12 months? 3. Number of "attacks" of asthma in a week" 4. Number of visits to your physician in the last year? 5. Number of time you awake with asthma symptoms in a week? 6. Medication history: Name of medication a. b. c. Frequency of use Month? , Month?

7. Any immediate family members with asthma? Parents. 8. Any family members who smoke? Father 9. Do you use Peak Flow meters at this time? 10. Have you ever had a Lung function test? Pulmonary Testing: PEFR FVC , Mother,

., Brothers , Brother

, Sisters, ,Sister

FEVi

FEWFVC

FEF25-75

12

APPENDIX 11 1
SEVERITY OF ASTHMA and ASSOCIATED SYMPTOMS I. Introduction

Patient Name: Medical Record No:

Person completing this form

Date:
. Patient:D, parent/guardian

Please rate the following symptoms by marking the lines according to severity: II. Severity of Asthma Symptoms None 0 1 Cough Wheeze Chest tightness Exercise tolerance Total Asthma Symptoms Unbearable 10

III. Total Assessment of Symptoms Please keep in mind your previous responses regarding your individual symptoms, please rate your overall symptoms using the following scale:

0 1
Key to Symptoms:

10

1<mild>3

4<---moderate-->6

7<severe->9

0=

None

1 -3 = Mild - signs and symptoms alleady present but minimal awareness; easily tolerated 4-6 = Moderate - Definite awareness of signs and symptoms which is bothersome but tolerable 7-9 = Severe - Sign/symptom is hard to tolerate, may cause interference with activities of daily living and/or sleep 10 = Unbearable - Can't function, can't sleep, can't work, miserable, etc. IV. Severity Based on Quality of Life Good 0 1 Genera! quality of life ~ 0 = 2 ~ 3 4 5 6 7 8 9 Very Poor 10

Symptoms do not interfere with quality of life

1-3 = Mild - trivial or insignificant impact of symptoms on work, school and other activities

13

4-6 =

Moderate - noticeable, inconvenient or annoying is affected by symptoms at work, school, or during other activities; performance at work or school d occasionally (once or twice a week); sleep is disturbed significantly once a week; social or recreational activities are occasionally avoided because of less enjoyment of these activities.

7-9 = Severe - significant, troublesome or disturbing impact on work, school or sleep; efficiency of performance at work or school is adversely affected to a significant degree or on a daily basis; work or school days missed because of symptoms and/or physician visits; sleep is disturbed significantly twice weekly or more; social and/or recreational activities often avoided and enjoyment of activities diminished significantly 10 = Very severe - sleep disturbance most nights; symptoms significantly impair work or school performance as well as social and/or recreational activities

V. (A) Past Medications (including alternative medications) that you have used in the past and how effective were they? 1) Asthma Not Effective Very Effective

2) Other

(B) Present Medications 1) Asthma Not Effective Very Effective

2) Other

14

APPENDIX V
References: 1. Horwitz RJ, Busse WW; Inflammation and asthma. Clin Chest Med 1995;16:583620 2. Heimlich HJ, Patrick EA; The Heimlich maneuver - Best technique for saving any choking victim's life. Postgrad Med 1990; 87(6): 38-53 3. Heimlich HJ, Hoffmann KA, Canestri FR: Food-Choking and Drowning Deaths Prevented by External Subdiaphragmatic Compression. Ann Thoracic Surg 1975; 20(2):188-195 4. Heimlick, HJ, Heimlich, J. How the Heimlich Maneuver helps Asthma Victims. Allergy Hotline, 1997; 6(2): 1,5 5. Koop CE: The Heimlich maneuver. J US Pub Health Serv 1985; 100(6): 557

15

Study Budget

Principal Investigator: Anne St. John, MB, BS Study Coordinator Study Title: Heimlich Maneuver for Asthma Sponsor: Investigator Initiated Study ID STUDY BUDGET
Admhiisfrative Charges (A) # of Units, Cost/Unit $ 1,500.00 1 $ 3,000.00 1 $ 2,000.00 0 $ 1,500.00 I 0 $ 4,000.00 $ 500.00 0 $ 1,200.00 0 $ 1,000.00 0 0 $ 500.00 $ 1,500.00 0 Administration Costs Subtotal Overhead (20%) Total Start Up Costs EventCqst " . 35.00 75.00 20.00 20.00 100.00 50.00 100.00 15.00 12.00 125.00 145.00 Total Cost^ 1,500.00 3.000.00 1,500.00

Study Start-Up (protocol rev., Contract,recruit.Adv.)

Principal Investigator charge Study Manager charge ERB Preparation/Submission ** DSMB fees per review and teleconference ** Amendment Fee (if required) ** SAE resolution / handling +* Audits (FDA or Sponsor) ** Add-on procedure ** Study Cancellation by Sponsor **

S $

s
$ $ $ $ $ $

s
S $ $
v

6,000.00 1,200.00 7,200.00

Screening Process Patient Accrual Informed Consent process Inclusion/Exclusion Criteria Vital signs (BP, HR, Temp) Physical Exam Pulmonary function baseline testing Biochemistry profile Hematology profile Urinalysis Urine drug screen HIV, HBV, HCV

(B) $ $ $ $ $ $ $ $ $ $ $

1 of Units
1 1 1 1 1 1 1 1 1 0 0

>Iotal;<M:^'''
35.00 75.00 20.00 20.00 100.00 50.00 100.00 15.00 12.00

$ S $ $ $ $ $ $ $

s
$ S $ $ $ $ $ $ $ 30.00 25.00 20.00 30.00 . 125.00 15.00 300.00 120.00

Treatment / Follow-up (C) Visit / unit fee PFT / Peak Flow measuring and recording Vital Signs Brief Physical Exam Safety Labs (Chem, CBC, Urinalysis) Diary check and assessment Adverse Events Subject compensation - $10.00 per visit x 12)

# of times $ 30.00 1 $ 25.00 1 $ 20.00 1 S 30.00 1 S 125.00 1 $ 15.00 1 $ 50.00 6 $ 120.00 1 0 $ Screening (B) / Treatment(C>Subtotal Overhead (20%)

s
$ ,VY'-'1,0*2tfog" $, \ 218.4Xt: ,$;:,.. s / . T,3i;a^0H 60

. , :

' . ' ' .

- . '

, -

. .

: .

>

":-

' :

' : : ' (

- ^

1 ;

' '

>

, , TfTAL

#.

; n^mm?

TOTAL, ADMINISTRATIVE COSTS (A) ;$ ,;,: 6s000iOO TOTAL SCRFEN1NG/FOLLOW-UP (B. C) $ -,(5,520^0 TOTAL DIRECTCOSTS :s ;; 7f,s2o OVERtfRs. *S . i^,3(J4.(J0TOTAL .S 85,824.00 **-Items tobelnvoicedasrequifledTiiicliAsfrirna Study BWqet-Barbados-xIs . ' "

RE: Details of study

Subject: RE: Details of study From: "Charles Pierce" <charles@piercel.net> Date: Fri, 25 Jul 2003 11:12:54 -0400 To: "'M. Anne St. John'" <mastj@sunbeach.net> CC: "Henry J. Heimlich, MD" <heimlich@iglou.com> Anne, Many thanks for the quick reply. Is the attached basically correct and can you add to the list of "costs" covered by you. Even those that are SOC (standard of care). Good looking Protocol (R) Best, Charles

********************************************** Charles H. Pierce, MD, PhD Phone: 513 681 4084 Fax: 513 681 4094 Email: Charles@Piereel.net URL: http://Dr.Piercel.net

^^***************** ^L*^***************

Grant

Subject: Grant From: "Charles Pierce" <cpiercel@cinci.rr.com> Date: Mon, 25 Aug 2003 12:35:43 -0400 To: "Anne St John, MD" <mastj@sunbeach.net> CC: "Livi Forde, MB, DM " <DocLAForde@hotmail.com>, "Henry J. Heimlich, MD" <heimlich@iglou.com>

Anne, Sorry for the delay but I have had more than a full plate. Now I am down to the crunch. The chair of the allocations committee tells me that we have the money and he is sure that I will get what I want. The only problem is that he needs the form almost immediately now (Of course I have procrastinated a tad). Have attached the form I will be using and have spoken to the chair Gust now) about what not to be concerned with. OK, you will be the Applicant (1) so I will need a complete Address (2) The QEH will be the organization (3). Lets put a date of organization (4) that is real. For 5, I can do this but would appreciate your comments regarding B and C. 6, 7 are Not applicable (N/A) For 8, it might be nice to list the hospital director or even the board if this is easily available. 9 will be you as chair of Pediatrics. 10 is N/A. 11 will be referred to the protocol. 12, 13 and 14 are N/A and I will be writing cover letter and signing the form on your behalf. The cover letter (which I will send in advance to you and Livi for approval, comments etc) will indicate the reason for the study and all that good stuff. I would like to involve "South" somehow maybe by indicating that they are supporting this study in some way. Certainly they will be the beneficiaries of Dr. Heimlich's visit which he again spoke to me about. He remains keen to come down there. I am excited about this as it will give me a chance to come down again also. I think you can count on this if you can borrow till this gets settled. Hope you can get this back to me this week. Best, Charles
*:*********************************************

Charles H Pierce, MD, PhD --one: 513 681 4084 rax: 513 6814094 Email: Charles@Pierce1.net URL: http://Dr.Pierce1.net
n * * i ************************* ***************

wi:

8/25/03 1:41PM

J
CHARLES H. PIERCE, MSC, M D , PIERCE ONE CONSULTING PHD

5563 REGIMENTAL
CINCINNATI, OHIO

PLACE

45239

Owen J. Wrassman, Chair Allocations Committee Rotary Foundation of Cincinnati 441 Vine Street, Suite 2112 Cincinnati, Ohio 45202 Dear Owen

18 September 2003

Find attached the completed "Grant Application" for needed funds to allow the completion of the study entitled: A Prospective Historic Controlled Study on the Utility of Using The "Heimlich Maneuver for Asthma" (HMM) as an Adjunct in The Management of Asthma in Children and Young Adults You can imagine the difficulty we have had in finding a qualified location and Principal Investigator for this important study. The problem has been funding as the study does not involve pharmaceutical agents thus making support difficult at best - no matter how important or serious the disease and the intervention to be scientifically assessed. A great deal of credit goes to Dr. Anne St. John who has seen the need for this study to be completed and has managed to get covered most of the costs for the conduct of this study. The supporting documentation and attached items are the following: Breakdown of the needed funding for study conduct Special quotation of a refurbished PFT unit for this project Why study asthma and why studying asthma in Barbados is critical How the Heimlich Maneuver Helps Asthma Victims - the reason for a need for a controlled / scientific study 5. The actual study protocol with has been approved by the Barbados 1RB 6. The total study budget It is my view that this Rotary club's involvement in this study, which will allow it to go forward, will be most significant. In the end, if the study documents the anecdotal evidence that the "Heimlich Maneuver for Asthma" we will have supported a procedure that will benefit children the world over. Yours in Rdtary, 1. 2. 3. 4.

ROTARY FOUNDATION OF CINCINNATI 441 Vine Street, suite 2112 Cincinnati, Ohio 45202 Grant Application

Exact name of applicant: Anne St John, MB, BS, FRCP(C), FAA. Department of Paediatrics, Principal Investigator 2. Address of applicant: Queen Elizabeth Hospital Martindale's Rd, St Michael Barbados, West Indies

Nature of applicant organization (i.e., nonprofit corporation, trust, informal organization, etc.): Queen Elizabeth Hospital, Barbados, West Indies 4. 5. Date organized: 1930

Please provide the following: A. B. Amount requested: $5,800.00

Estimated number of children who will benefit from the program: Literally hundreds of thousands The Potential benefit from the results of a well controlled study on the benefits of the "Heimlich Maneuver for Asthma" is tremendous. On the Island Nation of Barbados alone the incidence of cases and the death rate is more that twice that of the US. It is similarly high throughout the Caribbean. Hard to put a number but a conservative estimate would be many hundreds of thousands of children and more adults throughout North America would benefit. On the study in question, there will be 60 children over the age of 6 years who will immediately benefit but the results will be of great benefit to children as well as all persons with asthma in Barbados and the Caribbean. Once published, the benefit has the potential to be worldwide.

C.

Purpose of the Grant (to include goals, objectives, and expected results) The study in question will educate patients (and their families) who have asthma about how to improve their lung function without drugs by the application of a more gentle Heimlich maneuver with the goal of decreasing the number of asthmatic attacks thus improving the quality of their life by preventing the need to go to the hospital for aerosol therapy and by breaking attacks. Breaking or stopping an "attack" of asthma which is an episode of acute bronchospasm will have an immediate effect in reducing the death rate from this condition. Please see the attached study protocol entitled "A Prospective Historic Controlled Study on the Utility of Using The 'Heimlich Maneuver for Asthma' (HMM) as an adjunct In the Management of Asthma in Children and Young Adults" which has ethics committee approval and is about to be underway at the Queen Elizabeth Hospital in Barbados. The expected results are to decrease the number of 1) deaths from asthma, 2) asthmatic attacks, and 3) visits to the hospital ED (asthma bay) for aerosol therapy.

6.

Give the amount of total grant funds received for the most current previous year available. Detail where these funds came from, (i.e. government grants, private foundations, private individual donors). Attach a copy of the most recent annual report or tax return if available. The total study cost is estimated to be in the range of $ 85,000.00 US of which all but about $ 15,000.00 has been procured through Government, Hospital and Department funds. Some of the costs will be made up by physician donated time. The costs above do not include Pulmonary Function equipment, Peak Flow meters and the cost of the diaries themselves

7.

State the amount of your current assets as of your last year-end. A. B.

N/A N/A

Provide a breakdown of restricted amounts and unrestricted amounts.

Provide a breakdown of how the restricted amounts are to be spent and how the non-restricted funds are to be spent N/A

8.

Please list the name(s) and address(es) of applicant's governing board. Mr. Andrew Watson, Director Queen Elizabeth Hospital

9.

Who (name, address and telephone number) will administer the giant applied for? Anne St. John, MB, BS, Chair, Department of Paediatrics Queen Elizabeth Hospital, Martindale's Rd, St. Michael, Barbados Phone: 246 436 6450

10.

Has the applicant or any of the persons named in 8 or 9 ever been a member of the Rotary Club of Cincinnati or an organization that applied for or received a grant from the Rotary Foundation of Cincinnati. No A. If yes, please provide the details thereof.

11.

Describe and attach a copy of the instrument that sets forth the purpose and described the applicant's activities: Please see attached study Protocol and full study budget

12.

Has the applicant received a ruling or determination letter from the Internal Revenue Service recognizing its exempt status under IRC 501(c)(3)? If yes, attach a copy. N/A Has the applicant filed a notice pursuant to IRC 508(b) requesting recognition that it is not a private foundation and that it is not a publicly supported charity as defined in 170(b)(l)(A)(6) or 509(a)(2) as more further described in Rev Proc 89-23? N/A A. B. If yes, when filed? If granted, when granted. Attach a copy. Has the applicant received any notice from the IRS that its notice or statement has failed to establish that applicant is not a private foundation, an operating foundation, or a publicly supported charity as the case may be? Attach any IRS determination letters relative to private foundation status.

13.

C. 14.

Control will exist if the private foundation, together with its disqualified persons, by aggregating votes or positions of authority may require the grantee to perform (or prevent the grantee from performing) any actions, which significantly affect the grantee's operations. Is the applicant controlled by the above private foundation? No

The undersigned hereby certifies that the foregoing information is correct to the best of my knowledge arid information.

Signature

Name: Address:

Charles H Pierce, MD, PhD 5563 Regimental Place Cincinnati. Ohio 45239

Telephone Number: Date of Application:

513 6814084 25 August 2003

A Prospective Historic Controlled Study on the Utility of Using The "Heimlich Maneuver for Asthma" (HMM) as an adjunct in the Management of Asthma in Children and young Adults

Additional Funds Needed*

Research assistant/ nurse @ $3007month x 12 months

Part-time help really needed for this study

3,600.00 1,100.00 900.00 200.00 5,800.00

Spirometer (refurbished per Spirometrics quote)

A greatly reduced price arranged by C. H. Pierce, MD

Peak Flow meters

45 @ $20.00

15 supplied by The Rotary Club of Barbados South

Secretarial (Stationery/Copying/typing etc)

Total

Other costs including Investigator time, Statistician, Pulmonary Function equipment, laboratory needs, clinic time and supplies supported by grants from various sources including the Department of Pediatrics of the Queen Elizabeth Hospital of Barbados, The Rotary Club of Barbados South, and the Government of Barbados. At no cost to the study, Dr. Heimlich has consented and volunteered to travel to Barbados as a guest of the Rotary Club of Barbados South for a public lecture and a medical lecture. It will be the first time that Barbados will have had the-honor of hosting this world famous man on the island.

irometrics
22 Shaker Road, P.O. Box 680 Gray, ME 04039 Contact: Wanda Cyr Tel: 800-767-0004 ext 218 Fax: 207-657-4123

Barbados Quotation
Date: 6/11/03 Quote#:DQ3628 Bill To Pierce One Consulting/Clinic 5563 Regimental PI Cincinnati, OH 45239 Attn. Charles Pierce, MD Fax: 513-681-4094 Tel: 513-681-4084 Ship To **Please advise if different than Bill To**

Ship Via UPS Ground-Unless otherwise specified

Payment Terms Credit Card or Net 30 Days (Upon Credit Approval)

Shipping Terms: F.O.B. Gray, Maine USA Delivery: 2 - 5 Days ARO OPTION# 1 Quantity Item Description Direct Package Price $1,100.00 Extended Price

1Ea

Refurbished LTE

FlowmateLTE Spirometer - Refurbished Package

Includes: ***6 Month Warranty Parts & Labor*** 2-Muuthpiece/Filter (#2175) 1 - Syringe Adapter (#16056) 1 - Operation's Manual (#M2500LTE) Instructional In-service Video

$1,100.00

lEa 1Bx lEa lEa lPk

2125 2175 3326 3355 2110

3L Calibration Syringe Mouthpiece/Filter (Box of 50) HP Desk-jet Printer Printer Cable Nose Clips (Pkg of 100) Subtotal: Shipping and Handling are prepaid and added at time of purchase.

Included Included Included Included Included $1,100.00

(D
Research Study: The Heimlich Maneuver in the Management and Prevention of Asthma Why Study Asthma in BARBADOS
Why Asthma? Of all the conditions affecting children and adults, asthma stands almost alone by the fact that, despite adequate therapy, the incidence and prevalence and death rate is increasing - almost around the world. Some of the noteworthy facts include the following: Asthma is the 6th most common chronic disease in the USA, affecting more than 5% of the US population. Over 14,600,000 Americans have this condition called asthma of which a disproportionate number (4,800,000) are children. The prevalence has increased more that 60% in the last decade and, alarmingly, there has been a greater than 70% increase in children. The death rate from asthma has increased greater than the increase in numbers would predict. Presently there are 3,500-4,500 deaths each year from this condition. (2.0 /100,000) Asthma is the number one cause of missed school in the US causing a staggering 10,000,000 missed school days a year. The economic costs are impressive: 6,800,000+ doctors office visits a year 1,000,000+ emergency room visits a year 430,000+ hospital admissions a year with 4+ days in hospital TOTAL COST > $12,400,000,000 in the US per year

Why Barbados? This island nation has a surprising problem with asthma with an incidence more than twice that of North America. The death rate of 4.5 /100,000 is more than twice that of the US. One would not normally think that a tropical island that is known more as a vacation spot and which enjoys year round temperatures in the 70's and 80's and an almost continuous warm breeze would be afflicted with asthma. Certainly, the reason is not pollution, as some have blamed for the increase in the US. This is a project designed with the expectation and intention of having a significant, durable and sustainable impact on the unacceptably high mortality and morbidity from a medical problem (Asthma) in children in Barbados.

Barbados is a small, stable, and well-educated (highest literacy in the Western Hemisphere) island Country in the Caribbean with a population of about 266,000 persons. Although a noted vacation spot, the island and its people can ill afford the morbidity and mortality from a sometimes preventable and often easily treatable disease. Far too many young children die each year. The incidence and death rate from asthma has been shown to be more than twice that of the U.S. or Canada. The yearly average is more than 12,000 Emergency Room visits to treat patients in an asthmatic crisis and an eye-popping and rather alarming 12 deaths a year (one per month). This figure is staggeringly high compared to that of North America especially when "emergency" treatment (via simple aerosol) or the "Heimlich Maneuver for Asthma" could and should be available or used either at home for the severe asthmatic or at local community clinics. Cincinnati has about one death a year from asthma. Asthma is a worldwide problem of increasingly importance but nowhere is it so prevalent and deadly as in the island nation of Barbados. These deaths should be totally preventable which is the reason for this study at this time, which is intended to "make a difference".

* Jane Murray Heimlich

How the Heimlich Maneuver Helps Asthma Victims

Heimlich, HJ, Heimlich, J.How the Heimlich Maneuver Helps Asthma Victims; Allergy Hotline 1997; 6(2): 1-2 (reprinted with permission of the author) {Editor's Note: Dr. Henry Heimlich, a Cincinnati physician, is the famed inventor of the Heimlich Manewser and his wife, Jane, is the author of "What Your Physician Won't Tell You". The following article was especially written for Allergy Hotline.) At a conference five years ago, a woman raised her hand and related an unexpected incident. "My sister is an asthmatic," she said. "One day when I was visiting, she suddenly couldn't breathe and was turning blue. The only emergency measure I knew was the Heimlich Maneuver. I did it -- she immediately took a deep breath -- and recovered.d Soon after that, I received a letter from the mother of a four-year-old girl describing the onset of an asthma attack. In this case, the attack was so severe the child could not even inhale her medication. "I was about to rush her to the emergency room, but I knew there wasn't time." Almost instinctively, she performed the maneuver and the child began breathing normally. To understand the effectiveness of the maneuver in asthma, let's take a quick look at what happens during an asthma attack. Asthma attacks, which consist of prolonged spells of wheezing and shortness of breath that can be fatal, occur when muscles surrounding the airway contract, narrowing the air passages, the linings of which are chronically swollen and inflamed. Mucus fills the airway and acts as a valve, i.e., when the asthmatic breathes in, the airway opens up and air slides around the mucous plugs. On exhaling, mucous plugs clog narrowed airways and the air cannot get out. Trapped stale air distends the lungs, making both inhalation and exhalation difficult. Pushing up on the diaphragm with the Heimlich maneuver compresses the lungs, expelling trapped air and the flow carries away mucous plugs, thus clearing the airway and ending the asthma attack. The Heimlich Maneuver is *best known for saving choking victims. Since I introduced it in 1974, more than 50,000 lives have been saved by its use in the United States alone. In performing the maneuver, you press up on the diaphragm, which compresses the lungs, causing a flow of air that expels a choking object that is blocking the airway. More recently, the maneuver has been shown to save the lives of drowning victims. For 35 years, the use of mouth-to-mouth for treating drowning has been a tragic error. You cannot get air into water-filled lugns. Administering pressure on the diaphragm jump starts breathing. The maneuver in drowning is recommended by the National Pool and Water Park Assn. (Ellis and Associates), which certifies lifeguards to use it as the first step in treating drowning victims.

Our job now is to spread the word about using the maneuver in asthma. There is no time to waste. According to the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (NIK), more than 15 million Americans suffer from asthma. Fourteen Americans die during asthma attacks every day, exceeding 5,000 deaths each year. Last year, 22 children died of asthma attacks in one New York City hospital emergency room, despite the availability of endotracheal intubation, a procedure wrought with complications. There is evidence that the Heimlich Maneuver can also prevent an asthma attack from occurring. Studies show that performing the maneuver on a regular basis keeps the lungs free of mucus. Asthmatics have been taught to perform the maneuver on themselves and mothers perform it on their children several times each week. (Frequency depends on the severity and the number of attacks each patient's experiences.) Reports of patients, ranging from age four to an 82-year-old physician, say that the maneuver not only prevents an asthma attack but even wheezing does not occur. At present, physicians in different parts of the country are teaching asthma patients to use the maneuver prophylactically, as well as in an emergency. As more asthmatics learn about this technique, it will reduce the need for asthma drugs, which are not only costly but can cause deadly reactions. When performed on asthmatics, the Heimlich Maneuver (done 2 to 4 times or until the attack subsides) need only be done very gently because you are expelling air and mucus, not a solid choking object or water. If you use the Maneuver to overcome or prevent an asthma attack, please share your experiences with us at the Heimlich Institute.

Reprinted with permission of Henry J Heimlich, MD with the addendum that since this article there have been many similar reports and at this time studies are underway to answer the question "Does the 'Heimlich Maneuver for Asthma' have an impact on asthma including severity, number of attacks, Emergency room visits, use of prescribed medications, missed days of school, and deaths due to asthma?"

INCOME BUDGET Rotary Club of Cincinnati - Club 17 District 6670 Other Rotary Clubs in District 6670 Rotary Club of Barbados South District 6670 Matching funds (possible $20,000) Total $ 10,000.00 5,000.00 10,000.00 15,000.00 $40,000.00

EXPENSE BUDGET Equipment for Hospital and Clinic use: Aerosol machines (Pari ProNeb) 48 @ $80.00 each (for hospital wards and community clinics) Reusable Aerosol Nebulizers (Pari LC Star 500@ $9.95) (Pari LC Pediatric with mask 300@ $8.45) Devices for the Asthma Association of Barbados: Peak Flow meters (Mini-Wright - 500 adult, 250 pediatric @ 11.00 Spacer devices (ACE Aerosol Cloud Enhancer -1,200@ $5.50) (ACE MDI spacer with pediatric mask - 500@ $11.00) Equipment for the Department of Pediatrics Asthma study: Pulmonary Data Service's KoKo spirometers (2) and other Supplies for the "Heimlich Maneuver for Asthma" project Total 3,840.00 4,975.00 2,535.00

7,550.00 6,600.00 5,500.00

9,050.00 $40,000.00

The Asthma Association of Barbados will distribute the Peak Flow meters and spacers. This is a respected and active voluntary community organization. This organization will be of value in disseminating the therapeutic aids as well as publicizing the study on the benefit of the "Heimlich Maneuver for Asthma". Probably because Asthma is the leading cause of missed school days in the world (and also in Barbados), the eventual training of teachers and/or guidance councilors, as well as parents, in the performance of the "Heimlich Maneuver for Asthma" would be an excellent long-range benefit from this project. Barbados has 139 schools (84 Primary, 22 Secondary, 26 Private and 7 "special needs").

WORLD COMMUNITY SERVICE PROJECT ASTHMA in the Caribbean

Sponsored By: Cincinnati Rotary Club - Club 17 (District 6670) Cincinnati, Ohio, USA Rotary Club of Barbados South (District 7030) Bridgetown, Barbados, WEST INDIES Description: This is a project designed with the expectation and intention of having a significant, durable and sustainable impact on the unacceptably high mortality and morbidity from a medical problem (Asthma) in Barbados. Barbados is a small, stable, and well-educated (highest literacy in the Western Hemisphere) island Country in the Caribbean with a population of about 266,000 persons. Although a noted vacation spot, the island and its people can ill afford the morbidity and mortality from a sometimes preventable and often easily treatable disease. Far too many young children die each year. The incidence and death rate from asthma has been shown to be more than twice that of the U.S. or Canada. The yearly average is more than 12,000 Emergency Room visits to treat patients in an asthmatic crisis and an eye-popping and rather alarming 12 deaths a year (one per month). This figure is staggeringly high compared to that of North America especially when "emergency" treatment (via simple aerosol) or the "Heimlich Maneuver for Asthma" could and should be available or used either at home for the severe asthmatic or at local community clinics. Asthma is a worldwide problem of increasingly importance but nowhere is it so prevalent and deadly as in the island nation of Barbados. These deaths should be totally preventable which is the reason for this project, which is intended to "make a difference". This project aims to provide the three components (education, research, and material goods) of the triad important to have a lasting impact on any health problem. Education: Education of the islands Physicians, Nurses, and the population with the condition is the essential foundation to not only treat but to prevent Asthma. Also, education of the life-saving benefits of emptying the lungs of mucus, which the research project will demonstrate. Material Goods: Equipment in the form of aerosol therapy devices, spacers and peak flow meters to be used in hospital wards, community Clinics, local practicing physicians, and severe asthmatics. One of the goals is to supply 40+ Nebulizers and associated equipment for the community clinics. This will,

surely, markedly decrease the death rate along with decreasing the number of hospital visits, which are definitely more expensive and time consuming. Research project support: Very little beats objective evidence that even the simplest procedure works than the results from a study carried out by respected members of the medical profession. Part of this project will be to support such a study on the effectiveness of the "Heimlich Maneuver for Asthma" by documenting the patients condition before and after this procedure and recording the change in frequency of needed medicines or trips to the emergency department or lowering of the death rate. Status: The project is not currently operating but was developed when a Rotarian physician was preparing for a lecture he was invited to present on the subject of "Asthma" for the Department of Medicine and Clinical Pharmacology at the Queen Elisabeth Hospital in Bridgetown, Barbados. He became aware of the increased local problem that, although well known to the physicians of Barbados, was not being resolved. Discussions with the hospital's chest physician (Dr. Timothy C. Roach), the director of the Emergency Room (Dr. Raana P. Naidu), and the chairperson of the Department of Pediatrics (Dr. Anne St John), confirmed that almost no aerosol machines or pulmonary function machines were available other than at the hospital's emergency room due to their very high cost in Barbados. It was also determined that many asthmatics were not using their medications properly and few used spacer devices which greatly increase the amount of medicine reaching the lungs. Both education and these supplies are considered essential for the successful management of asthma and are clearly needed on the island. Clearly, the addition of the possibility of saving lives, lessening the need for expensive medications was an important consideration in this project. The additional research project, which is very likely to demonstrate that the simple application of the "Heimilch Maneuver for Asthma" greatly reduces the need for hospital visits and prevents deaths will be the frosting. Club Participation: The Rotary Club of Cincinnati and other interested Clubs in District 6670. We would purchase the aerosol machines and delivery devices (Tubing and masks), peak flow meters, spacer devices, Pulmonary function machines and arrange for these items to be shipped to Barbados. The Rotary Club of Barbados South will arrange for clearance of customs and will arrange for the distribution of this equipment, which will be at the Queen Elizabeth Hospital or wherever needed, with the help of the Asthma Association of Barbados. The Respiratory Unit of the Queen Elizabeth Hrspital would own the equipment and the Asthma Association would own the patient aid devices.. Other Agencies: The Asthma Association of Barbados has agreed to organize

publicity and to distribute the aerosol devices, peak flow meters and the spacers. Distribution will be free according to need. This Association has also agreed to assist in the educational aspects of this project. The Government of Barbados would be expected to waive duty and facilitate the clearance of customs as these devices and equipment as it will be owned by the Hospital, which is part of the government. International Needs: Money -. The major rationale is so that all the islands asthmatics are reasonably close to, or have available, this type of simple and highly effective emergency therapy. In addition, the money to help start the research into a procedure that may really make a difference in both the morbidity and mortality of asthma in Barbados and the Caribbean. The cost of the machines is $70.00 each (A minimum of 48 are required, which is $3,360.00). That of the re-usable nebulizers and masks is $9.95 for the adult and $8.45 for the pediatric units, (see attached) Shipping costs are not part of this request as it is expected that they will be allowed as baggage or shipped at a carriers expense or otherwise paid for. The cost of the peak flow meters has been arranged at $10.00, which is reduced from the usual cost of $29.95 for the adult device, and $19.95 for the pediatric device. (See attached budget). Volunteers - From the Rotary Club of Barbados South working with the Department of Pediatrics, the Respiratory Unit of the Queen Elizabeth Hospital, and the Asthma Association of Barbados will place and maintain the equipment so that it is available when and where needed. Contact: Henry J. Heimlich, MD or Charles H Pierce, MD, PhD Rotary Club of Cincinnati - Club 17 441 Vine Street, Suite 2112 Cincinnati, Ohio 45202 Phone 513 421 1080

Approved:

John Neuhart, President Rotary Club of Cincinnati - Club 17

Date"

Thomas A Powell ,

Date

District Governor, District 6670

MARTINDALES

ROAD,

ST. MICHAEL,

BARBADOS

TEL. 6450 FAX. 5374

2003. 09. 18

246-436246-429-

The President Rotary Club of Cincinnati. Dear President On behalf of the Paediatric Unit of the Queen Elizabeth Hospital, I am writing to express sincere gratitude for the shipment of numerous boxes containing medical equipment and related items, which arrived on the island of Barbados in March, 2003. I ws advised by Dr Charles Pierce that the donation was facilitated through the Rotary Club of Cincinnati. The supplies which were received have been distributed to the Paediatric Unit, and other beneficiary areas of the hospital of the Queen Elizabeth Hospital where children will benefit. These include the operating Theatre, Orthopaedic Ward, Cardiovascular Services,Surgical and Medical Intensive Care Units, and the Barbados Asthma Association. The equipment and supplies will go a long way in continuing to enable an underprivileged segment of the population of Barbados to benefit from the donation as part of the Rotary Club of Cincinnati's REACH PROJECT. In particular, I would like to thank Dr Charles Pierce who liased with me, arranged the packing, coordinated and facilitated the shipping arrangements. Once again, he has master-mined and completed what" only be described as a truly sterling effort. Sincerely yours M. Anne St John M. Anne St John MB. BS (UWI) FRCPC FAAP Consultant Paediatrician

Wf

Original Message From: M. Anne St. John [mailto:mastj@sunbeach.net] Sent: Monday, September 22, 2003 8:45 PM To: Charles Pierce Subject: Donation :ROTARY REACH PROJECT Dear Charles At last, I have managed to distribute/ get all of the items which you sent to the various locations within and outside of the QEH --except for the Barbados Asthma Assoc. , which is to be collected by Rosie Pollard. I would like to thank you especially and all of those involved for the sterling effort which will, continue to enable a segment of the (less fortunate) population of Barbados to benefit from the donation of medical equipment and related items, as part of the Rotary Club of Cincinnati's WCS and REACH PROJECT. I have sent an attachment to the President of your Rotary Club which I would like you to deliver. I hope that this letter will meet with your approval. Yesterday, we did the month 1 follow-up of the "Heimlich Maneuver for Asthma" study. I am hoping that the parent and patient compliance will last for all of the visits. Regards Anne .

9/24/03 8:09 A M

I: o:: _ : : I IO A H.V REACH PROJECT -

Subject: Donation : ROTARY REACH PROJECT From: "Charles Pierce" <cpiercel@cinci.rr.com> Date: Tue, 23 Sep 2003 16:18:54 -0400 To: " M e Almquist" <AlmquistA@NKU.edu>, "Ute Papke " <Utemunich@aol.com> CC: "Ron Molen" <RMolen@ohiomasonichome.org>, "Bob McElroy" <bob@mediasign.com>, "Henry J. Heimlich, MD" <heimlich@iglou.com>
Hi, Can anyone open the attached letter? And then send it back to me? So we can get it to President Bill et al. Thanks,, CHP ******************************************** Charles H Pierce, MD, PhD Phone: 513 681 4084 Fax: 513 681 4094 Email: CharlesOPiercel.net URL: httpr/TbrTpT^rceTTnet *********************************************

FW: Supplies

Fmn: "Oorfes P i r o * <cpicicc I igcinci rr.com> Date; Tut 23 Sep 2003 12:28:20 -0400 To- 'Lie Pipk= " <Ottrr.^ich 5 aoI.com>, "Arae Almquist" <AJmquistA@NKU.edu>, "Ron Molen" <RMolen@ohiomasonicliome.org>, "Bob McElroy" <bob@rnediasign.com> T h i s v s s f o r t h e box specifically s e n t no the Asthma Association : V r - - : ' - . : wr<o : . r : : ~ contact with most asth 1 t i c s on the island. This is a voluntary Association and the work they do to help this problem among the poorest of the population is indeed laudatory. This lady, R c s i e Poliard is ar.d has been the mainstay in terms of dedication and t i n e spentWhat we se:v: tnem was a good supply of spacers and a couple of aeroaol cevices. The first great, iy increase the effectiveness of the inhaler **yoe asthma medications. This is to the point that most of us treating asthma state quite clearly that to not use a spacer is to not treat oneself optimally and almost guarantee failure. In this regard, this Association does outstanding work. This lady has been very helpful in finding patients for the Study on the utility of the "Heimlich Maneuver for Asthma" which is now just underway on the island. Best, Charles Charles H Pierce, MD, Phi

original Message F m , Rosita Pollard [ . i , to;RAPr/. lard.,cem raltaank nrg. t,b] , Sent: Tuesday, September 23, 2003 11:42 AM To: charl&a^piorccl.net Subject! Supplies Dr. Pierce, '-.any, many thanks for the box of supplies. We really appreciate your kindniss and consideration. Thanks for remembering the Asthma Association. We are still making available spacing devices and peak flow meters if cne become a member of the Association, and we held a raffle for the box which contained the videotape, book, A/C and PFM. We received a donation recently from Scotia Insurance - a used computer, a TV and VCR, Here is proof that the box was received. ; _ . the best!, Rosie .:

Fax
HEIMLICH INSTITUTE
311 STRAIGHT STREET CINCINNATI OHIO 45219 513-559-2391 FAX 513-559-2403 heirniicli@iyiou.com
www.heirrJichiristitute.org

Name: Fax: Phone: From: Date: Subject: Pages:

Charles Pierce 681-4094 981-4084 Eric G. Spletzer September 24, 2003 Anne St. John attached letter 2

Comments: Hi, This letter looks great. Unfortunately, this was the best we could do in opening it. (I think she has letterhead images imbedded in the document that are giving us problems opening it.) Do you know if she's working with a Windows or Mac system? Eric

Benefiting Humanity Through

- -

Affiliated with Deaconess Associations Inc.

Original Message From: M.Anne St.John [mailto:mast3@sunbeach.net] Sent: Monday, November 10o 2003 7=48 PM To: Charles Pierce Subject: study Dear Charles I am writing to give you an update on the progress of the asthma study. We completed the 3rd f/u visit on Sat and have 60 patients enrolled. However there's one hiccup--- I now owe the research nurse/assistant for 2 sessions which we have completed and have promised to pay her as soon as those promised funds arrive. Any further feedback on this? The cheque should be made payable to : The QEH, Paediatric Department Asthma research Study The information has been keyed on to a database by the same research nurse/assistant which the statistician at the Chronic Disease Unit which is a research centre (opp. to the QEH) where Henry Fraser is the Professor. Regards Anne.

RE: study

Subject: RE: study From: "Charles Pierce" <cpiercel@cinci.rr.com> Date: Thu, 13 Nov 2003 12:08:09 -0500 To: "'M.Anne St.john"' <mastj@sunbeach.net> CC: "Henry J. Heimlich, MD" <heimlich@iglou.com> Anne, Just back from a meeting that had me away for a week. I have been puzzled at the "radio silence" from our Club. I was told that we would get funds some time ago and there has been one delay followed by another. I have had a call in to the chairman (Owen Wrassman) since I got back. He has just returned my call (as I was writing this)and we were approved for $3,000 US which he has asked for the address etc. He will probably send it early next week. He may call you to confirm the addresses which I gave him. I am going out of town again today but trust Owen to take care of this. It is not what we asked for but I am told it is the maximum they give from this fund. An option is that we reapply next July or we get help from another source. Henry, have you an ideas for a couple thousand? Or less? Best regards, Charles PS; My personal regards to Henry Fraser when you see him ********************************************** Charles H Pierce, MD, PhD Phone: 513 681 4084 Fax: 513 681 4094 Email: CharlesQPiercel.net URL: http://DrTpier~cel.net * * * * * * * * * ^ ^ * * * * * * * * * * * *********************

Original Message From: M. Anne St. John [mailto:mastj-3suTibeach.net] Sent: Friday, November 14, 2003 7:21 AM To: Charles Pierce Subject: Re: study Dear Charles Thanks for all of your help. It would be a pity to have to discontinue the study now. We have been analysing (on a continuing basis) some of the data which we have collected to date. The statistician (whom I begged to assist... no funds available for this) has asked whether the statistics of the study which H. H used in adults could be sent for her to get some ideas re numbers etc. Please attend to this asap. regards On Thursday, November 13, 2003, at 01:08 PM, Charles Pierce wrote:

Original Message From: Wrassman, Owen [mailto:OWrassman3rwbaird-com] Sent: Wednesday, November i 9 , 2 003~4':52 " PM To: 'CharlesCTLcel.net' SubjectT Allotationi Charles sorry that I haven't advised you about the allocations committee, since we spoke last. The meeting that I was to speak to Richard LaJeunnesse about expediting your application, became very complicated and it was not appropriate to pursue it that night. I will see Richard tonight @ bowling and also tomorrow at the Trade Fair. I will try to get this done. You will understand later when I explain all the circumstances, that there is a possibility that the allocation my not occur until Dec 4th...I'11 speak to you when you return owen Owen J Wrassman First Vice President - Investments Robert W Baird & Co. Inc. 25 Crestview Hills Mall Road Crestview Hills, KY 41017 Direct: 859-485-3709 Toll Free: 877-792-7595 Fax: 859-426-3450 Cell: 513-678-0595

RE: Allocations

Subject: RE: Allocations From: "Charles Pierce" <cpiercel@cinci.rr.com> Date: Wed, 19Nov 2003 21:11:44-0500 To: '"Wrassman, Owen"' <OWrassman@rwbaird.com> CC: "Henry J. Heimlich, MD" <heimlich@iglou.com> Owen, What will be will be. We will just have to wait but I hope not too long as this important study did get started on the thought that we would be able to help at least a bit. As you have seen, this project will benefit literally millions of children and adults with asthma if it demonstrates that the Heimlich maneuver for asthma reduces attacks of asthma and deaths. It is Wednesday evening and I am back but leave Thursday morning for NYC for a day. I assume that you have the information to send the check when it is approved. Thanks a bunch for your help. Best regards, Charles ********************************************** Charles H Pierce, MD, PhD Phone: 513 681 4084 Fax: 513 681 4094 Email: CharlesOPiercel.net URL: http://Dr.Piercel.net *********************************************

RE: Any news?

Subject: RE: Any news? From: "Charles Pierce" <cpiercel@cinci.rr.com> Date: Tue, 25 Nov 2003 21:07:54 -0500 To: '"M.Anne St.john"' <mastj@sunbeach.net> CC: "Henry J. Heimlich, MD" <heimlich@iglou.com>, "Owen Wrassman" <owen.wrassman@ubspw.com> Anne, I have not but I am in Montreal at this time and for this week. I had heard that the amount I gave you had been approved but was awaiting a signature or two. Red tape - I do not like it very much. I will try to find out some answers this week but have expected Owen Wrassman to be in contact with you directly. I believe he has all the information and addresses. Best regards and we are very pleased to hear that the study has started. Charles ********************************************** Charles H Pierce, MD, PhD Phone: 513 681 4084 Fax: 513 681 4094 Email: CharlesOPiercel.net URL : http://Dr.Piercel_.net *********************************************

Original Message From: M.Anne St.John [mailto:mastjSsunbeach.net] Sent: Tuesday, November 25, 2003 5:31 AM To: Charles Pierce Subject: Any news? Dear Charles I have nit received any correspondence from the Rotary Unit there. Any news on the donation for the study? Regards Anne.

FW: study

Subject: FW: study From: "Charles Pierce" <cpiercel@cinci.rr.com> Date: Thu, 27 Nov 2003 20:51:59 -0500 To: "Henry J. Heimlich, MD" <heimlich@iglou.com> Henry, I do not know what to do about this and I am in Montreal as I write t h i a . Would you c a l l Owen Wrassman and see what gives. Could you find something to send her while we are waiting? Actually, she needs a bit more than Owen says we are getting so if we want this study to go on, I think she needs some help. Will call you next week when I am back. Best, Charles ********************************************** Charles H Pi prce* MD PhD Phone: 513 681 4084 , Fax: 513 681 4094 Email: Charles@Pe_rcel.net URL: http . //Dr.Piercel.net *********************************************

HEIMLICH INSTITUTE
311 STRAIGHT STREET CINCINNATI OHIO 45219 513-559-2391 FAX 513-559-2403 heimlich@iglou.com
www.heifrfchinsrrt ule.org

December 3, 2003

Anne St. John, M.D. Queen Elizabeth Hospital Martindales Road Chnst Church Barbados, W.I. Dear Dr. St. John: The enclosed Heimlich Institute Foundation check is to help continue the asthma research study. I am aware additional funds will be coming from Rotary. Should you have any questions regarding the basis of the use of the Heimlich maneuver to prevent asthma attacks, please do not hesitate to contact me. I look forward to learning the results of the study as your work progresses.

Henry J. President

(ch, M.D., ScD

end.

Benefiting Humanity

INTERNATIONAL EXPRESS AIRBILL- For Information Call 1-800-ABX-INTL- (1-800-229-4685)

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aa Study

^Subject: Help for the Asthma Study From: "Charles Pierce" <cpiercel@cinci.rr.com> Date: Wed, 3 Dec 2003 12:28:21 -0500 To: "Henry J. Heimlich, MD" <heimlich@iglou.com>

Hank, Wow, that is just great news. The $1,000.00 will be a big help while waiting for the Rotary Red tape. The total of $4,000.00 while not as much as needed will go a long way to completing the study. Dr. Anne St. John recently told me that "The cheque should be made payable to : The QEH, Paediatric Department - Asthma research Study". The address of the Queen Elizabeth Hospital is QEH, Martindales Road, Christ Church, Barbados, W.I.. The letter should be addressed to the attention of Andrew Watson, Executive Director of the QEH. " Mall is slow there so I wouldrecommend sendmgit a fast way. As to results, I would imagine that this would not be known until the blinding is opened at the end. It will be interesting to learn the ease of learning and acceptability of the technique by the parents and the evidence that this led to better control and less trips to the Emergency department. Let alone the reduction of "attacks". Glad to be back but Montreal was a good experience and it was actually fun being a doctor again. See you at the meeting on Thursday. Kind regards, Charles

**********************************************

Charles H Pierce, MD, PhD Phone: 513 681 4084 Fax: 513 6814094 Email: Charles@Pierce1.net

."ILWSlgg.

-----Original MessageFrom: M. Anne St John [mailto:mastj@sunbeach.net] Sent: Wednesday, May 05, 2004 9:54 PM To: Charles Pierce Cc: paediatrics@sunbeach.net Subject: Re: Rotary Grant

Dear Charles My profound apologies, I did receive both cheques and sent thank you letters to both parties- Dr Heimlich and the President Rotary Club of Cincinnati and the address from whence the cheque and letter had been sent. I had thought that you would be notified about the thank you letter, however that was my error, I will have the secretary of Paeds. here send you a copy of the letter. In fact, we will be doing a follow-up visits for the parents this Sat. We are almost at the end

I of 2

5/6/04 10:54 AM

RE: Rotary Grant

of the study. At this stage, many of the patients have had to be cajoled to attend f/u visits. The data has been collated on a database, and so far we have been using the CDRC's statistician for "free assistance". Regards, Anne.

On Wednesday, May 5, 2004, at 08:49 PM, Charles Pierce wrote: Anne, Have not heard from you and I am worried that you did not receive the $2,500.00 sent to you from the Rotary Club. I will go back in my Email files if you tell me that you did not get this money. I understand you received the $1,000 from the Heimlich Institute. Let me know if we have to try to find out what happened. I and we are excited to hear news of the study and any indication that the procedure works the way it theoretically does. Interestingly, I read a short note (Now I cannot find the reference) that "forced complete expiration" is beneficial for asthma patients. Sounds like what you are doing only that group did not identify the procedure with "Heimlich" and his maneuver. Best, Charles

RE: Rotary Grant

Subject: RE: Rotary Granl From: "Charles Pierce" <cpierce]@cinci.rr.com> Date: Thu, 6 May 2004 10:39:25 -0400 To: "'M. Anne St. John'" <mastj@sunbeach.net> CC: <paediarrics@sunbeach.net>, "Henry J. Heimlich, MD" <heimlich@iglou.com>

Anne, Hmmmmm, well there was a lapse in communication on our part. No one told me except I knew you received the grant earlier from the Heimlich Institute. Have copied Dr. Heimlich to keep him in the loop on the study so we can plan to come down to Barbados in the future. We know well how difficult it is to get follow-up study visits especially if things are going well or the study is long (as in this case). We are very interested in your impression (and later in the results) of the study and the procedure. Incidentally, I have heard again of others in the US independently suggesting "gentle but forceful expelling of air by chest compression" / "Forced complete expiration" as being of benefit to asthmatics. They do not call it the "Heimlich maneuver for asthma" but it sure sounds like this is what is being suggested. Interesting. Yours appears to be the first "research study" which looks at this procedure prospectively. Dare I hope that the results are favorable to the initial questions asked in the study? Best and kind regards, Charles
**********************************************

Charles H Pierce, MD, PhD, FCP, CPI Phone: 513 681 4084, 513 708 8233 (cell) Fax: 513 6814094 Email: Charles@Pierce1.net URL: http://Dr.Piercec.net
*********************************************

A61:015

THE QUEEN ELIZABETH HOSPITAL

MARTINDALES ROAD, ST. MICHAEL, BARBADOS

Our Ref:

Your Ref:

Telegraphic Address: Genhos Tel. PABX. (246) 436-6450 Fax: (246) 429-5374

Dale:

2004-05-11

Dr Henry Heimlich The Heimlich Institute 311 Straight Street Cincinnati OHIO 45219 Dear Dr Heimlich It is with a great deal of embarrassment that I learnt from Charles Pierce that you have not receive my letter of acknowledgement of your generous donation of $1000 USD towards our Asthma study in children using the Heimlich Manoeuvre at the Queen Elizabeth Hospital. I am writing to thank you for your kindness, interest and generosity in the study. Of course Charles Pierce has played a significant role and influenced myself and co researcher Dr Stephen Feanny (Paediatric Allergist) in doing the study. We look forward to your visit later in the year and will send you the results as soon as all data has been collated and analysed. Sincerely

Dr M A St John Consultant Paediatrician cc Dr Charles Pierce

DIVIDER

Celebration of 50 years of health research in the Caribbean

5tfh Annual CHRC Council and Scientific Meetings

Rovanel's Resort
rrogramme

Wednesday, April 20, 2005

ML Irvine Bay Hotel 9:00 a.m. 50th Annual CHRC Council Meeting Chairman: Sir Neville Nicholls, Chairman, CHRC

Rovanel's Resort

9:00 a.m.

Caribbean Association of Nephrologists

and Urologists (CANU)

Thursday, April 21, 2005 Sessionl

Ballroom A 8:00 0,m.

Opening
Chairperson:: DTSimeon andD Picou

Feature Lecture I: CHRC: Past, Present and Future Prof. Henry Fraser

(O - I)

8:45 a.m

Influence of Mother Child Interaciions on the Development of Low Birth Weight Term (LBW-T) and Normal Birth Weight (NBW) Toddlers SM Chang. TD Wachs, SP Walker. JMeeks Gardner Prevalence ofPeeh ypertension and Us Relationship to other risk factors for Cardiovascular disease in Jamaica TS Ferguson. N Younger, MK Tulloch-Reid. MBIxiwrence Wright. D Ashley. RJ Wilks Risk of stroke in sickle cell disease: the Sickle Cell Unit (SCU) experience 1992-2002 MMoosang. TEForrester. IHambleton. CA McKenzie. MReid Seroprevalence ofSexually Transmitted Infections among Accepted and Deferred Blood donors in Jamaica.

(O -2)

9:00 a.m.

(O

3)

9:15 a.m

(O

4)

9:30a. m.

CA Powell. SP Walker, $MChang, SMGrantham-McGregor (O 45) 11:30 a.m. Psychosodal, cognitive and sodo-demographic factors associated with under- and over- weight among 11-22 year old Jamaican children MJackson. MSamms-Vaughan. D Ashley Dietary habits and the indigenous diet of the Turks and Caicos IslandsImplicaiions for island-specific nutrition intervention TEMaitland Adolescent Obesity, Disproportionately Affects Girls in Barbados P Gaskin. H Broome. C Alert. B Griffith. H Eraser An assessment of frutt and vegetable intakes in Caribbean: the fourcountry study DDRamdath. P Johnson. R Young, P Trotter. FJ Henry LUNCH

(O

46)

11:45 a.m.

(Q-47)

12 noon

(O - 48)

12:15 p.m.

12:30p.m..

Session 6b Ballroom B (Q-49)

Concurrent

Clinical Studies II Chairperson:: A Patrick and A Frankson

11:00 a.m.

Utilisation of the Heimlich Maneuver as an adjunct in the Management of Asthma in Paediatric Patients: A Prospective Study SFeanny. MA St. John, P Howard Risk factors in asthmaiic children visiting the emergency room in Central and East Tr'uudady JReemaul, A Sharma. F Mohammed. S Bootoor. A Panday. A Ramdass, Mlvey. LMPinto Pereim Small babies on small islands: Care and outcome of premature infants in Antigua 1990 to 1999 TC Martin. B Smart. P Hansen. L LoveII-Robert, V Francis. Fetal Macrosomia: Prevalence and Associated Factors in Barbados. G Barrow, A Carter Prevalence ofCOPD in acute medical patients in Trinidad RHarrinarine. VAbiraj. A Ah. NLacki. NMahabir. VRamouiar. C PoonKing, TSeemungal Gender differences in coping responses and beliefs about infertility between Afro-Caribbean mv, and women undergoing In Vitro ' Fertilisaiion AMPot linger. C McKenzie. JFredericks. VDacosta, S Wvnter. D Everett. Y Walters Stroke following snake bites by the Fer-deLance' Bothrops lanceolatus in Martiniqu:: a report of 3 recent strokes

0-50)

11:15 a.m.

(O 51) (G-52)

11:30 a.m.. 11:45a.m.

(0-53)

12noon

(G-54)

12:15 p.m.

(0-55)

12:30 p.m.

Session 6b-Concurrent

Clinical Studies II
Chairpersons: AL Patrick and A Frankson

(O - 49) Utilization of the Heimlich Manoeuvre as an adjunct in the management of asthma in paediatric patients: a prospective study SFeanny, MA St John, P Howard Department of Paediatrics, Queen Elizabeth Hospital, Barbados Objective: The objective of the present study was to determine the usefulness of a modified Heimlich Manoeuvre for treatment of asthma in Barbados. Materials and Methods: Subjects were randomly selected from the Accident and Emergency database and studied prospectively between August 2002 and July 2003. Written consent was obtained from parents for participa tion of patients. Screening included history, present condi tion, and fulfilling inclusion/exclusion criteria, with physi cal examination and lung function tests according to the study protocol. Results: The study population consisted of 67 patients aged 6-16 years with a control group of 34 patients and a study group of 33 patients. Spirometry values for the study group showed progressive improvement in FEV (17.85%) and PEFR (30.8%), which was statistically significant. Changes in the control group readings of 6.75% and 13% respectively were not statistically significant. All symp tom scores improved: 75% for exercise tolerance and 28% for quality of life scores in the study group was (statistically significant) contrasting with total asthma scores of 37% and 0% changes in the quality of life scores in the control group. Improved spirometry and symptom scores were consistent for the study group but fluctuated in the control group. No adverse effects were reported. Conclusion: This study has provided data to support the potential benefits of the modified Heimlich Manoeuvre as adjunctive therapy for asthma, with a consistent improve ment in objective parameters of spirometry, subjective symptom scores and quality of life assessment.

(O - 50) Risk factors in asthmatic children visiting the emergency room in Central and East Trinidad JReemau,, A Sharma,FMohammed, S Bootoor A Panday, A Ramdass, MIvey; LMPinto Pereira Faculty of Medical Sciences, The University of the West Indies, Caribbean Epidemiology Centre, Trinidad and Tobago Objective: To investigate risk factors associated with acute asthma in children presenting to the Emergency Room (ER) in Central and East Trinidad. Design and Methods: A cross-sectional study inter viewing consenting parents/guardians of 300 patients on a pilot-tested questionnaire to explore risk factors for re peated visits to the ER was completed in children # 16 years attending paediatric asthma clinics at three primary care health facilities. Results: The male/female ratio was 1.8:1, mean age was 8.2 ( 3.63) years and 72.3% (217) patients had suffered the first asthma attack before three years. An inverse rela tionship exists between the age of the first asthma attack (p < 0.01) and presenting age of the child (p < 0.01) with the number of emergency visits in the previous 12 months. Dust triggered wheezing most frequently Repeated ER use in the past 12 months W3s associated with smoke (p < 0 025s) pets (vt < 0 025ss odours (vt < < 005s) and inhaled corticosteroids (ICS) and P2 agonist metered dose inhaler
(MT)T^ In < 0 05 s ! Children appH 1-5 year<; i n d 6 - 1 2 y e a r s

were more likelv to et attacS^n the d r v ^ l r a i n v season r^ctivelWni0oS5^ TreataentcSian^waTS S ^ ^ v S v e t l ^ f f i O y S n ^ S h e ^ Conclusions: Dust frequently triggers wheezing and repeat ER visits in children are associated with pets, odours, smoke and ICS with 02 MDI. Education of parents/guardians of asthmatic children to identify and avoid triggers for wheezing and learn efficient MDI use is recommended. The early onset of asthma in children and age-related climatic changes needs to be explored.

West Indian Med J 2005; 54 (Suppl. 2): 45

Guyana Health Information Digest

Volume 6, Number 1, June 2005 Compilers Wallis Best Plummer, PhD Omar Khan, BSc,DipEd. Curtis La FleurM.D. M.Sc FUNDED BY: The Dreyfus Health Foundation 205 East 64 t h Street, Suite 404 New York, NY 10021

THE GUYANA HEALTH INFORMATION DIGEST (G.H.I.D.) is a publication of the Communication for Better Health (CBH) section of the University of Guyana / University of Texas Medical Branch at Galveston / Dreyfus Health Foundation (UG/UTMB/DHF) Collaborative Health Development Projects.

June 2005 Communication for Better Health Faculty of Health Sciences University of Guyana Tuykeyen Campus, Georgetown. I S S N : 1021 - 7525

0.47; CI 0.30, 0.75). Anxiety/depressive symptoms (OR 0.64; CI< 0.45,0.92) were associated with lower risk of overweight. Obesity was associated with social problems (OR 1.90; CT, L16,3.11) and lower in girls m households with more persons < 18 years (OR, 0.28; 0.09,0.83). Conclusions: Psychosocial problems are associated with overweight and obesity in young adolescents in Jamaica and should lie considered in overweight prevention and treatment programmes.

[Source:

West Indian Medical Journal Vol 54 (Suppl 2), 2005 no.O-45 p. 43]

ADOLESCENT OBESITY, DISPROPORTIONATELY AFFECTS GIRLS IN BARBADOS

P Gaskin, H Broome, (' Alan, B Griffith, HS Fraser School of Clinical Medicine and Research, The University of the West Indies, Cave HillCampus and Chronic Research Centre, TA1RI, UWI, Cave HillCampus, Wellness Clinic, Queen's College Barbado Disease

Objective: To describe the prevalence of overweight and obesity and their association with physical activity (PA); to examine associations of wdight status defined by BMI cut-points with perceptions of body size and diet quality Design and Methods: A cross-sectional study conducted in Barbados in a cohort of 164 boys and 236 girls, 11-16-year old school children, gathered to study physical education practices. Results: Overweight (15% boys, 17% girls) and obesity (7% boys, 12% girls) levels were high. Maternal obesity predicted weight status such that reporting an obese mother increased the odds of being overweight by 5.3 (95% CI: 2.7, 10.5). Physical activity was inversely associated with BMI and weight status, however levels were low, with 50% of girls reporting no sti-uctured physical activity. Most subjects reported some recreational physiccal activity but this was not associated with BMI and did not differ by weight status. Overweight subjects tended to misclassify themselves as normal weight. Conclusions: Our findings indicate that Barbadian adolescent girls are more affected by the emerging obesity epidemic, a pattern also seen in adults This suggests that gender specific cultural factors are promoting female adiposity with a strong contribution of maternal obesity, which may be explained by perinatal and other intergenerational effects. These observations highlight the urgent need for prevalence studies and for description of cultural and other barriers to physical activity.

[Source: West IndianMedicalJoumal

Vol 5-1 (Suppl 2), 2005 no.O-47 p. 44 j .

UTILIZATION OF THE HEIMLICH MANOEUVRE AS AN ADJUNCT IN THE MANAGEMENT OF ASTHMA IN PAEDIATRIC PATIENTS: A PROSPECTIVE STUDY
^ ^ ^ _ ^ _ - _ ^ _ f c SFeanny, A St John, P Howard Department of Paediatrics, Queen Elizabeth Hospital, Barbados

Objective: The objective of the present study was to determine the usefulness of a modified Heimhch Manoeuvre for treatment of asthma in Barbados. Materials and Methods: Subjects were randomly selected from the Accident and Emergency database and studied prospectively between August 2002 and July 2003. Written consent was obtained from parents for participation of parents. Screening included history, present condition, and fulfilling inclusion/exclusion criteria, with physical examination and lung function tests according to the study protocol. Results: The study population consisted of 67 patients aged 6-16 years with a control group of 34 patients and a study group of 33 patients. Spirometry values for the study group showed progressive improvement in FfiV (17.85%) and PfiFR (30.8%), which was statistically significant. Changes in the control group readings of 6.75% and 13% respectively were not statistically significant' All symptoms scores improved: 75% for exercise tolerance and 28% for quality of life scores in the study group was (statistically significant) contrasting with total asthma scores of 37% and 0% changes in the quality of life scores in the control groun Improved spiromeliv and svmptom scores were consistent for die study group but fluctuated in the control group. No adverse elTects were reported. Conclusion: This study lias provided data to support the potential benefits of the modified Heimhch Manoeuvre as adjunctive therapy for asthma, with a consistent improvement in objective parameters of spirometry, subjective symptom scores and quality oflife assessment.

DIVIDER

Reference

Subject: Reference From: 'Ossfcs Pierce" <cpiercei geinci.rr.com> Daie W l 14 Apr 2004 15:01:23 -0400 To: 'Hemy J. Heimlich, MD"<heimlich@iglou.com>

Hank, Sorry to bother you in the middle of your move but thanks for your willingness to be one of my references to be on staff at the Deaconess Hospital. Have attached my latest : - . _ :z vatch you up on what i havo beei doing Best regards, ChaIleo
r-r-r-rwr-xxxxic* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * *

Charles H Pierce, MD, PhD, FCP, CPI 5563 Regimental Place C-ncinnati, chio u523o Phone: Fax: Email: URL: 513 681 4084 513 6814094 Charles@Pierce1.net http://Dr.Pierce1.net

*********************************************

i V

UfeU x

WU/IWL<11,JJ

iOJUV

IglUUl

HEIMLICH INSTITUTE
311 STRAIGHT STREET CINCINNATI QUO 45219 513-669-2391 FAX513-559-2403 h9rtich@iglou.com
www.hdir**lnititiit.?

MEMORANDUM
To: Tony Woods

From: Henry Heimlich, M.D. Date: September 17, 2004

Dear Tony; I truly enjoyed our meeting the other day. You mentioned your interest in establishing drug testing programs. I know Dr. Charles Pierce from the Rotary Club. One of his primary fielis is doing just that. Enclosed is his Curriculum Vitae. If you are interested, please let me know. By the way, Vic Wells is presently in Kenya.

Benefiting Humanity Through Health and Peace

Affiliated with Deaconess Associitions Inc.

Charles Harmon Pierce, MSC, MD, PhD

5563 Regimental Place Cincinnati, Ohio 45239 Dr. Pierce is presently working as an independent consultant to the pharmaceutical industry, academia, and the medical research industry. He is based in Cincinnati, Ohio, where he is professor of Pharmaceutical Science in the College of Pharmacy at the University of Cincinnati College of Medicine. He is also the V.P. of Medical Affairs for North America for Harrison Clinical Research and the Associate Director of the Clinical Trials Office at the Cincinnati Children's Hospital Medical Center. In the Medical Research industry, Dr. Pierce has worked in a management capacity and has been involved in the education of clinical investigators and other staff. One area of knowledge and expertise, emanating from his 8 years as the Medical Director and PI followed by three years as in upper management in a medical research organization, has led to the development of a manual based Clinical Investigators study program. In addition, he is frequently actively involved in courses giving the new, as well as the established clinical investigator, an understanding and appreciation of the ethical principles as well as the science of clinical research involving human subjects Dr. Pierce brings to the table practical know-how from more than 40 years of scientific research interest, activity and application. He is an innovative problem solver starting with an original work Masters thesis in 1961 through a Doctorate in Surgery/Pharmacology in 1974 and continuing throughout 24+ years in the practice of clinical medicine as a family physician and 13 years in the medical research industry. Dr Pierce has been lecturing to students, pharmaceutical representatives and practicing family physicians or specialists in clinical pharmacology (practical therapeutics) for over 26 years and has been involved (often as the course director) in many CME courses aimed at the practical aspects of therapeutic problems in the cardiovascular and pulmonary fields among others. The condition where he has had the most prolonged interest and activity and where he has had the greatest impact has been in the fields of asthma and Clinical Research GCP. As a bona fide Clinical Pharmacologist (FCP in 1974) and Board Certified Family Physician (ABFP 1977) and with more than 12 years active management experience in the medical research industry, Dr. Pierce, brings a unique experience and perspective to what he does. He is an Emeritus fellow in the American College of Clinical Pharmacology (Regent 1995-2000, Chairman of the 2001 annual meeting) and active in the American Academy of Pharmaceutical Physicians (Instigator of the Clinical Investigators Seminar series). He is on the editorial board of the Journal of Clinical Pharmacology and the Good Clinical Practice Journal and the Board of Directors of the Annapolis Center for Science Based Public Policy. Outside of his vocational interests, Charles has been an active squash player for 44 years, a committed Rotarian for 23 years, and a hobby photographer. Through this, he lists his wife, Barbara, as his greatest asset and accomplishment. For additional information, see http://Dr.Pierce1.net and www.pmci.org

DIVIDER

Michelle Stultz, RN, CMSC, CPCS, Director, Medical Staff Office Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Dear Ms Stultz, Re: Charles H. Pierce, MD, PhD This note is in support of the appointment of Dr. Pierce to the medical staff of the Cincinnati Children's Hospital Medical Center. I have known Charles since late 1999 when he visited with me in connection with his position at the Phoenix research facility. As he works with the Clinical Trials office, I see him more than a few times a week. Having known him and having reviewed hi C-V and observed him in action, I believe I can give a good appraisal of him as a scientist, educator and person. He fares very well in all categories. I have not observed him with patients but have observed his interactions with staff and would believe that he possesses what is needed to be a caring compassionate physician. I do not question his medical knowledge especially after he recently passed the SPEX exam covering all of medicine. Dr. Pierce is a regular contributor at our weekly Clinical Pharmacology meetings and it is clear that he poses a range of knowledge which would be to the continuing advantage to the CHMC. He is also an organizer as he has been the Course Director of the yearly CCHMC Clinical Research educational effort of the CTO. He has been the Associate Director of the Clinical Trials Office for a couple of years now and is needed to help increase our research output. Charles is a credit to Clinical Pharmacology and I am certain that he will be a credit to the CCHMC. Presently he is a member of the GAC and has been active helping investigators work through the intricacies of industry sponsored clinical trials Please let me know if I can be of further assistance in this matter. Sincerely,

Floyd Sallee, MD, PhD Professor of Psychiatry and Pediatrics, Director, Pharmacology Research Center Cincinnati Children's Hospital Medical Center

Celebration of 50 years of health research in the Caribbean 5tfh Annual CHRC Council and dcientific Meetings

Rovanel's Resort
April 20-23, 2005 Programme
Wednesday, April 20, 2005
ML Irvine Bay Hotel 9:00 a.m. 50th Annual CHRC Council Meeting Chairman: Sir Neville Nicholls, Chairman, CHRC

Rovanet's Resort

9:00 a.m.

Caribbean Association of Nephrologists

and Urologists

(CANU)

Thursday, April 21, 2005 Session1

Ballroom A 8:00 a. m.

Opening
Chairperson:: DTSimeon and D Picou

Feature Lecture I: CHRC: Past, Present and Future Prof. Henry Fraser

(O - I)

8:45 a.m

Influence of Mother Child Interaciions on the Development of Low Birth Weight Term (LBW-1J and Normal Birth Weight (NBW) Toddlers SM Chang. TD Wachs, SP Walker, JMeeks Gardner Prevalence ofPreh ypertensum and Us Relationship to other risk factors for Cardiovascular disease in Jamaica TS Ferguson. N Younger, MK Tulloch-Reid. MBlxmrence Wright, 1) Ashley. RJ Wilks Risk of stroke in sickle cell disease: the Sickle Cell Unit (SCU) experience 1992-2002 MMoosang. TE Forrester. IHamhleton. CA McKenzie. MReid Seroprevalence ofSexually Transmitted Infections among Accepted and Deferred Blood donors in Jamaica.

(O -2)

9:00 a.m.

(O

3)

9:15 a.m

(O

4)

9:30a, m.

7
CA Powell, SP Walker, SM Chang, SM (O 45) 11:30 a.m. Grantham-McGregor

Psychosodal, cognitive and sodo-demographic factors associated with under- and over- weight among 11-22 year old Jamaican children MJackson, MSamms-Vaughan, D Ashley Dietary habits and the indigenous diet of the Turks and Ca'icos Islands: Implications for island-specific nutrition intervention TEMaitland Adolescent Obesity, Disproportionately Affects Girls in Barbados P Gaskin, H Broome, C Alert, B Griffith, H Fraser An assessment of fruit and vegetable intakes in Caribbean: the fourcountry study DDRamdath, P Johnson, R Young, P Trotter. FJ Henry LUNCH

(O

46)

11:45 a.m.

(Q-47)

12 noon

(O - 48)

12:15 p.m.

12:30 p.m..

Session 6b Ballroom B (Q-49)

Concurrent

Clinical Studies Chairpersons:

II A Patrick and A Frankson

11:00 a.m.

Utilisation of the Heimlich Maneuver as an adjunct in the Management of Asthma in Paediatric Patients: A Prospective SFeanny. MA St. John, P Howard

Study

(O-50)

11:15 a.m.

Risk factors in asthmatic children visiting the emergency room in Central and East Trinidady JReemauL A Sharma, F Mohammed, S Bootoor, A Panday, A Ramdass, Mlvey. LMPinto Pereira Small babies on small islands: Care and outcome of premature infants in Antigua 1990 to 1999 TC Martin, B Smart, P Hamen, L LoveII-Robert, V Francis. Fetal Macrosomia: Prevalence and Associated Factors in Barbados. G Barrow, A Carter Prevalence ofCOPD in acute medical patients in Trinidad RHarhnarine. VAbiraf A All. NLacki. NMahabir. VRamoutar, PoonKing, T Seemungal

(O 51)

11:30 a.m.,

(G-52)

11:45 a.m.

(O - 53)

12noon

(0-54)

12:15 p.m.

(0-55)

12:30 p.m.

Gender differences in coping responses and beliefs about infertility between Afro-Caribbean men and women undergoing In Vitro Fertilisation AMPoitinger. C McKenzie, J Fredericks, VDacosta, S Wvnier. D Everett, Y Walters Stroke following snake bites by the Fer-deLance Bothrops lanceolatus in Martinique: a report of 3 recent strokes

Guyana Health Information Digest

Volume 6, Number 1, June 2005 Compilers Wallis Best Plummer, PhD Omar Khan, BSc.DipEd. Curtis La Fleur M.D. M.Sc FUNDED BY: The Dreyfus Health Foundation 205 East 64 t h Street, Suite 404 New York, NY 10021

THE GUYANA HEALTH INFORMATION DIGEST (G.H.I.D.) is a publication of the Communication for Better Health (CBH) section of the University of Guyana / University of Texas Medical Branch at Galveston / Dreyfus Health Foundation (UG/UTMB/DHF) Collaborative Health Development Projects.

June 2005 Communication for Better Health Faculty of Health Sciences University of Guyana Tuykeyen Campus, Georgetown. I S S N : 1021 - 7525

0.47; CI 0.30, 0.75) Anxiety/depressive symptoms (OR 0.64; CI< 0.45,0.92) were associated with lower risk of overweight. Obesity was associated with social problems (OR 1.90; CI, 1.16, 3.11) and lower in girls m households with more persons < 18 years (OR, 0.28; 0.09,0.83). Conclusions: Psychosocial problems are associated with overweight and obesity in young adolescents in Jamaica and should be considered in overweight prevention and treatment programmes.

[Source:

West Indian Medical Journal Vol 54 (Suppl 2), 2005 no.O-45 p 43]

ADOLESCENT OBESITY, DISPROPORTIONATELY AFFECTS GIRLS IN BARBADOS

P (joskin, H Broome, C Aler,, B Griffith, HS Fraser School of Clinical Medicine and Research, The University of the West Indies, Cave Hill Campus and Chronic Disease Research Centre. TMRI, UWI, Cave Hill Campus, Wellness Clinic, Queenss College Barbado Objective: To describe the prevalence of overweight and obesity and their association with physical activity (PA); to examine associations of wdight status defined by BMI cut-pomts with perceptions of body size and diet quality. Design and Methods: A cross-sectional study conducted in Barbados in a cohort of 164 boys and 236 girls, 11-16-year old school children, gathered to study physical education practices. Results: Overweight (15% boys, 17% girls) and obesity (7% boys, 12% girls) levels were high. Maternal obesity predicted weight status such that reporting an obese mother increased the odds of being overweight by 5.3 (95% CI: 2.7, 10.5). Physical activity was inversely associated with BMI and weight status, however levels were low, with 50% of girls reporting no structured physical activity. Most subjects reported some recreational physiccal activity but this was not associated with BMI and did not differ by weight status. Overweight subjects tended to misclassify themselves as normal weight. Conclusions: Our findings indicate that Barbadian adolescent girls are more affected by the emerging obesity epidemic, a pattern also seen in adults This suggests that gender specific cultural factors are promoting female adiposity with a strong contribution of maternal obesity, which may be explained by perinatal and other intergenerational effects. These observations highlight the urgent need for prevalence studies and for description of cultural and other barriers to physical activity.

[Source: West Indian Medical Journal Vol 54 (Suppl 2), 2005 no.O-47 p. 44].

UTILIZATION OF THE HEIMLICH MANOEUVRE AS AN ADJUNCT IN THE MANAGEMENT OF ASTHMA IN PAEDIATRIC PATIENTS: A PROSPECTIVE STUDY
^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ t SFeannv, MA St John, P Howard Department of Paediatrics, Queen Elizabeth Hospital, Barbados Objective: The objective of the present study was to determine the usefulness of a modified Heimlich Manoeuvre for treatment of asthma in Barbados. Materials and Methods: Subjects were randomly selected from the Accident and Emergency database and studied prospectively between August 2002 and July 2003. Written consent was obtained from parents for participation of parents. Screening included history, present condition, and fulfilling inclusion/exclusion criteria, with physical examination and lung function tests according to the study protocol. Results: The study population consisted of 67 patients aged 6-16 years with a control group of 34 patients and a study group of 33 patients. Spiromeljy values for the study group showed progressive improvement in FEV (17.85%) and PEFR (30.8%), which was statistically significant. Changes in the control group readings of 6.75% and 13% respectively were not statistically significant' All symptoms scores improved: 75% for exercise tolerance and 28% for quality of life scores in the study group was (statistically significant) contrasting with total asthma scores of 37% and 0% changes in the quality of life scores in the control group. Improved spiromclry and symptom scores were consistent for the study group but fluctuated in the control group. No adverse effects were reported Conclusion: This study has provided data to support the potential benefits of the modified Heimlich Manoeuvre as adjunctive therapy for asthma, with a consistent improvement in objective parameters of spirometry, subjective symptom scores and quality oflife assessment.