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Volume 1.

DECEMBER 2016 - FEBRUARY 2017

Editorial by Dr. Rajesh Chawla

t gives me great pleasure to present to you the second issue of Pulmonary Communications.
I have received overwhelming response appreciating this initiative of National College of
Chest Physicians (NCCP). I am grateful to you for your support and encouragement.
In this issue Dr. Rohit Sarin, Director, National Institute of TB and Respiratory Diseases,

Delhi has clarified standards of TB care in India based on the revised strategies of WHO and
RNTCP.
Read full editorial on page 2

Contents
1.

NCCP News Headlines

2. Editorial
3.

Secretary's Message

4.

Standards for TB Care in India

7.

Current Status of Non-Invasive


Ventilation in Clinical Practice

9.

NCCP News Headlines


Comprehensive Pulmonary Medicine
eCourse being launched by National
College of Chest Physicians (NCCP) in
February 2017.

Pulmonary Rehabilitation

12. NAPCON 2016

Editorial Office

12. Criticare 2017

Dr. Rajesh Chawla

13. Journal Scan

Institute of Respiratory Medicine, Critical Care and Sleep Medicine,


Indraprastha Apollo Hospitals, Gate No.-2, 2nd Floor, Room No. 1223, Sarita Vihar,
Delhi-Mathura Road, New Delhi - 110076

16. Advertisement

Mobile : +91 9810033395 drchawla@hotmail.com

We request our esteemed readers to send their valued feedback, suggestions & views at
drchawla@hotmail.com

Editorial

MDR TB. Cartridge-based Nucleic

want to stress here that Pulmonary

Acid Amplification Test (CB-NAAT)

rehabilitation is not limited to

is the preferred first diagnostic test

exercise training but is a combination

for Pulmonary TB in children and

of education, behavioral change

patients living with HIV (PLHIV).

designed to improve physical and

He also clarified that Probable TB

emotional condition of the patient

is the terminology now used for

with chronic respiratory disease and

patients with symptoms suggestive

to promote long term adherence

of

to health enhancing program. The

TB

without

confirmation

Dr. Rajesh Chawla


Editor in Chief, Pulmonary Communications
President,
National College of Chest Physicians (India)
drchawla@hotmail.com

www.nccpindia.com

t gives me great pleasure


to

present

to

you

the

second issue of Pulmonary


Communications.

have

received overwhelming response


appreciating

this

initiative

of

National College of Chest Physicians


(NCCP). I am grateful to you for
your support and encouragement.
In this issue Dr. Rohit Sarin,
Director, National Institute of TB
and Respiratory Diseases, Delhi
has clarified standards of TB care in
India based on the revised strategies
of WHO and RNTCP. In this he has
clearly mentioned the importance
of rapid molecular tests which are
emerging as the first test of choice for

microbiological

(sputum

smear

goals of pulmonary rehabilitation

microscopy, culture and molecular

include

diagnosis), but with strong clinical

burden

and other evidence (e.g. X-ray, Fine

performance

Needle Aspiration Cytology (FNAC),

increased

histopathology) may be diagnosed

activities. The other goals are to

as Probable TB. One of the major

decrease psychological symptoms

change now recommended is the

& improve health related quality of

change in treatment strategy. Initial

life. That is why one requires the help

treatment in Intensive phase for two

of respiratory physicians, exercise

months of Rifampicin Isoniazid,

physiologists respiratory therapists,

Combutol & Pyrazinamide remains

physiotherapists,

the same but Continuation phase

nutritionist, social workers, patient

includes Rifampicin, Isoniazid and

educators & occupational therapists.

Ethambutol for four months.

Resources & lack of availability of

Once again we all need to remember

heath care professionals limits most

that TB is now a notifiable disease

of the pulmonary rehabilitation

since 7th May 2012, We should

program. But in India teammates

ensure that we notify all patients to

can take up the duel responsibility or

the District Nodal Officer & make

more roles to fill the non-availability

full use of the electronic notification

of staff members.

system called NIKSHAY. So in

We will have to escalate this initiative

this article Dr. Sarin has very

as it is very much promotable,

clearly answered everything about

provided we feel very strongly for it.

standards of TB care in India.

Non-invasive Ventilation has now

Pulmonary rehabilitation is never

acquired a definite role in the

considered important to be a part

management of patients with acute

of the treatment for most of the

and

pulmonologists. Majority of the

This is predominantly being used

stress is given to pharmacotherapy.

for acute respiratory failure. There

Dr. Deepak Talwar in his article on

is now great evidence for its use in

this subject has described in detail

acute exacerbation of COPD where

the

pulmonary

this is the standard of care unless

rehabilitation. Most of the physicians

there are contraindications. The

perceive this as exercise training, I

other conditions where its role has

components

of

minimizing
&

symptom

maximizing
with

autonomy

participation

chronic

exercise
in

&

daily

psychologist,

respiratory

failure.

Pulmonary Communications A quarterly Newsletter of National College of Chest Physicians

Message

ear Colleagues,
It gives me great pleasure that the II issue of the News Letter
of NCCP(I) -- Pulmonary Communications, has been published.

The First issue, which was released in the Joint meeting of NCCP(I) and
ICS on 25-9-2016 was greatly appreciated. Dr. Rajesh Chawla deserve the
credit for taking this initiative.
The National College of Chest Physicians (India) is having joint conference
with Indian Chest Society for last 17 years - named NAPCON and this year
the venue is Hotel Hyatt, Mumbai from Nov., 24-27, 2016.
The Conference will have distinguished faculty from India and Abroad.
The scientific programme has been made meticulously and covers all
the aspects of Pulmonary Medicine with seperate sessions on Thoracic
Surgery, Imaging, Environmental diseases, Smoking, Recent advances etc.
There are 14 workshops on the first day and I am glad to inform you that
all are almost full.
This year one session on "Veterans Speak" has been added, where Veterans
in the field will be giving their experience through lecture.

Prof. S. N. Gaur

I am sure that the NAPCON_2016 will be the best opportunity to interact

Secretary,

with reputed faculty and to update your knowledge on the subject.

National College of Chest Physicians (India)


&
Director (Acting)

I welcome you all. The website of NAPCON-2016 is http://www.


napcon2016.org./

V.P. Chest Institute, University of Delhi,

I also wish you all happy reading of the news letter of NCCP(I).

Delhi-110007.

Editorial Continuous .....

been proven are acute cardiogenic

found to be associated with poor

conducted by expert faculty at

pulmonary oedema, weaning in

outcome if you delay intubation.

various medical colleges to select

COPD, acute respiratory failure

Friends, once again I request you

PG students on merit basis and

in

host.

to send in articles, case discussions

the winners have been given

Although the evidence is not very

and information about upcoming

complementary registration and

robust, but it can still be used in

conferences. We shall be happy to

travel allowance. In addition for the

some other conditions like trauma

publish it.

first time there are 15 training cum

immunocompromised

patents, mild ARDS, community


acquired Pneumonia in COPD and
acute respiratory failure in OSA so
as to prevent endotrachial intubation
in these patients. We are well aware
that this modality is very useful in
avoiding intubation in many patients
but a word of caution that we must
know when to stop NIV and when
to intubate. If you delay intubation,
it increases mortality. NIV should
not be used in ARDS Hpatient where
P/F ratio is below 150 as it has been

I take this opportunity to welcome


everyone on behalf of National
College of Chest Physicians (NCCP)
& Indian Chest Society (ICS) to

hands on experience workshops on


24th November which have been
organized at various tertiary care
hospitals across Mumbai.

the NAPCON 2016. This annual

The

conference

has

excellent

conference has very unique features.

scientific program spread over 3

First time 250 Post graduate students

days. And it has been accredited

of Pulmonary Medicine, Internal

5 credit hours by Maharashtra

Medicine and allied specialties have

Medical Council.

been awarded NAPCON-2016 PG

Looking forward to welcoming

scholarship through preconference

you all!

PG QUIZ. The PG Quiz was

Pulmonary Communications A quarterly Newsletter of National College of Chest Physicians

Standards for TB Care in India


Tuberculosis is a very common disease in
India. It is important to diagnose and treat
according to the recommended standard
of care to achieve the best results
Standard 1: Testing and screening for TB
1.

Who should be Tested for TB ?

people with cough >2 weeks, fever


>2 weeks, significant weight loss,
hemoptysis etc. and any abnormality
in chest radiograph must be evaluated
for TB. Children with persistent
fever and/or cough >2 weeks, loss of
weight / no weight gain, and/ or h/o
contact with pulmonary TB should
be evaluated for TB

2.

Which is most common symptom of


TB?

The most common symptom of


pulmonary TB is prolonged cough
that lasts longer than the cough with
most other acute lung infections. The
evidence from India suggests that
cough lasting > 2 weeks is a more
sensitive indicator for TB

3.

Who should be regularly screened


for TB?

People living with HIV (PLHIV),


malnourished,
diabetics,
cancer
patients,
patients
on
immunosuppressant or maintenance
steroid therapy, should be regularly
screened for signs and symptoms
suggestive of TB.

4.

What Is enhanced case finding?

Enhanced case finding means


maintaining a high index of
suspicion for TB in all encounters
with health provider, with proactive
exclusion of TB using the appropriate
combination of clinical queries,
radiographic or microbiologic testing.
It should be done in People living
with HIV (PLHIV), malnourished,
diabetics, cancer patients, patients
on immunosuppressants, health care
workers, slum dwellers, Prisoners
etc.

Standard 2: Diagnostic Technology


5. Which
are
the
diagnostic
technologies available for diagnosis
of TB?

diagnosis of active tuberculosis.


Standardized TST may be used as a
complimentary test in children.
7.

How many samples should be tested


for diagnosis of pulmonary TB?

Two samples (a morning sample is


better than a spot sample for detection
of mycobacteria)

Standard 3: Testing for extra-pulmonary


TB
8.

What should be kept in mind when


Extra pulmonary TB is suspected.

Appropriate specimens from the


presumed sites of involvement
must be obtained for microscopy/
culture/ CBNAAT/molecular test/
histopathology examination and
drug sensitivity testing (DST)

Which patients should be screened


as presumptive MDR

15. What is probable TB?

Patients who have failed treatment


with first line drugs, paediatric nonresponders, TB patients who are
contacts of MDR-TB (or R resistance),
TB patients who are found positive
on any follow-up sputum smear
examination
during
treatment
with first line drugs, diagnosed TB
patients with prior history of antiTB treatment, TB patients with HIV
co-infection and all presumptive TB
cases among PLHIV.

10. What are the available tests for


diagnosis of MDR-TB?

a. Rapid molecular DST (as the first


choice)-LPA or CBNAAT

b. Liquid / solid culture-DST (at


least for R and H; and at least for
Ofloxacin (O) and Kanamycin (K),
if MDR). Liquid is preferred to
solid culture.

On detection of Rifampicin and


isoniazid resistance, patient must
be offered sputum test for second
line DST using quality assured
phenotypic(Liquid or solid culture)
or genotypic (CBNAAT or LPA)
methods, wherever available

c. CBNAAT:
preferred
first
diagnostic test in children &
PLHIV

12. What is the prevalence of HIV in TB


patients in India?

What is the status of serological tests


like Tuberculin Skin Test (TST) &
Interferon Gamma Release Assay
(IGRA) in diagnosis of TB?

13. Which TB patients should be offered


counseling for HIV testing

around 5%

All TB patients with active TB should


be offered HIV counselling and
testing.

Patients with symptoms suggestive


of TB without microbiological
confirmation
(sputum
smear
microscopy, culture and molecular
diagnosis), but with strong clinical
and other evidence (e.g. X-ray, Fine
Needle Aspiration Cytology (FNAC),
histopathology) may be diagnosed as
Probable TB.

16. Which patients are likely to be


treated for Probable TB?

The probable TB may be higher


in Children, Patients with extra
pulmonary TB or PLHIV.

Standard 6: Pediatric TB
17. What are the diagnostic tools in
children who are not able to produce
sputum?

11. Which patients should undergo


diagnosis of Extensively Drug
Resistant (XDR-TB)?

Prevalence of MDR-TB of 2-3% in


new, untreated TB patients and
around 15% in previously treated TB
cases

9.

a. Microbiological confirmation on
sputum

These are not recommended for the

Standard 5: Probable TB

b. Chest Xray as screening tool

14. What is the prevalence of MDR


TB among New & Retreatment
patients?

Standard 4: Diagnosis of HIV co-infection


in TB and Diagnosis of DRTB

6.

Dr. Rohit Sarin

Director, National Institute of TB &


Respiratory Diseases,
Sri Arbindo Marg, Delhi

In all children with presumptive


intra-thoracic TB, microbiological
confirmation should be sought
through examination of respiratory
specimens
(e.g.
sputum
by
expectoration, gastric aspirate, gastric
lavage, induced sputum, bronchoalveolar lavage or other appropriate
specimens) with a quality assured
diagnostic test, preferably CB-NAAT,
smear microscopy or culture.

18. Can children be treated for probable


TB?

YES, the diagnosis of probable TB


in children should be based on the
presence of abnormalities consistent
with TB on radiography, a history
of exposure to pulmonary TB case,
evidence of TB infection (positive
TST) and clinical findings suggestive
of TB

19. Can TST ( Tuberculin Skin Testing)


alone be used as diagnostic tool in
TB?

Pulmonary Communications A quarterly Newsletter of National College of Chest Physicians

20. What is the standard cutoff for TST


in India?

IAP and RNTCP recommend 10mm


as cut off

27. What are recommended weight


bands for dosing of TB treatment?

The RNTCP guidelines outline


dosing based on weight bands.
Suggested weight bands for adults
are: 30-39kg, 40-54kg, 55-70kg and
>70kg. Recommended weight bands
for paediatric patients are: 6-8kg,
9-12kg, 13-16kg, 17-20Kg, 21-24kg
and 25-30kg. Drug formulations are
available for matching these weight
bands.

34. Which patients should be screened


for Surgery in M/XDR-TB patients:

Standard 8: Monitoring the treatment


Response

35. What is the Treatment duration in


MDR-TB patients ?

28. Should the Intensive phase of


treatment be extended during the
treatment?

21. Do Serodiagnostic tests or IGRA


have a role in diagnosis of TB in
pediatric population?

Their role is same as in TST


mentioned.

Standard 7: Treatment with first line


regimen
22. What is the recommended regimen
for New TB Patients

The initial phase should consist


of two months of Isoniazid (H),
Rifampicin
(R),
Pyrazinamide
(Z), and Ethambutol (E). The
continuation phase should consist of
three drugs (Isoniazid, Rifampicin
and Ethambutol) given for at least
four months

23. Under what conditions can the


continuation phase be extended?

The duration of continuation phase


may be extended by three to six
months in special situations like
Bone & Joint TB, Spinal TB with
neurological involvement and neurotuberculosis. This can be done in
consultation with the concerned
specialist , relating to organ involved.

24. What is dosage frequency? Daily or


Intermittent?

All patients should be given daily


regimen under direct observation.
However, the country programme
may consider daily or intermittent
regimen for treatment of TB
depending on the available resources
and operational considerations as
both are effective provided all doses
are directly observed. All paediatric
TB patients and HIV associated
TB patients should be given daily
regimen under direct observation.

25. What are the recommended drug


formulations?

Fixed dose combinations (FDCs) of


four drugs (Isoniazid, Rifampicin,
Pyrazinamide, and Ethambutol),
three drugs (Isoniazid, Rifampicin
and Ethambutol) and two drugs
(Isoniazid and Rifampicin) are
recommended.

The extension of the intensive phase


is not recommended

29. How to assess response to treatment


in Extra Pulmonary TB?

In patients with extra-pulmonary


tuberculosis, the treatment response
is best assessed clinically. The help
of radiological and other relevant
investigations may also be taken. The
specialist in the concerned system
should also be consulted wherever
possible.

In children, who are unable to


produce sputum, the response to
treatment may be assessed clinically.
The help of radiological and other
relevant investigations may also be
taken. If required , a pediatrician may
be consulted.

31. What Is the recommendation for


monitoring during treatment?

International standards recommend


that a sputum sample should be
collected at the end of the intensive
phase (two months) and at the end of
treatment (six months) to monitor the
success of therapy

32. What Is the recommendation for


long term follow-up after treatment
is completed?

After completion of treatment the


patients should be followed up with
clinical and/or sputum examination
at the end of six and 12 months

Standard 9:
Management

33. What is the recommended treatment


regimen for MDR-TB (R resistant) ?

Drug

Resistant

TB

The regimen chosen for MDR-TB


may be standardized and/or based
on microbiologically confirmed drug

All patients of M/XDR-TB should be


evaluated for surgery at the initiation
of treatment and/or during follow
up.

Total treatment should be given for


at least 24 months in patients newly
diagnosed with MDRTB (i.e. not
previously treated for MDR-TB) with
recommended intensive phase of
treatment being six to nine months
and continuation phase of atleast
18 months after culture conversion.
The total duration may be modified
according to the patients response to
therapy.

36. When should the Second line DST


be done during the treatment of
MDR-TB ?

30. How to assess response to treatment


in Children?

26. What is the regimen recommended


for previously treated patients?
After MDR-TB (or R resistance) is
ruled out by a Quality Assured test,
TB patients returning after lost to
follow up, relapsing from their first
treatment course or new TB patients

susceptibility patterns. At least four


drugs (second line) to which the
organisms are known or presumed to
be susceptible, should be used. Most
importantly the regimen should
include at least Pyrazinamide,
Ethambutol, a later generation
Fluoroquinolone (such as high dose
Levofloxacin) and a parenteral agent
(such as Kanamycin or Amikacin),
Ethionamide (or Prothionamide),
and Cycloserine.

failing with first treatment course


may receive the retreatment regimen
containing first-line drugswith an
Intensive phase of three months and
a continuation phase of five months:
2HREZS/1HREZ/5HRE

NO, it may be used as a complimentary


test in children, in combination
with microbiological investigations,
history of contact, radiology, and
symptoms

During the course of MDR-TB


treatment, if the sputum culture is
found to be positive at 6 months or
later, the most recent culture isolate
should be subjected to DST with
second-line drugs (at least Ofloxacin
and Kanamycin) to decide on further
course of action.

37. What are the new drugs under


consideration?

The new drugs e.g. Bedaquiline,


Delaminid may be considered
whenever scientific evidence for their
efficacy and safety becomes available
as per the national policy for newer
antimicrobials.

Standard 10 : Addressing TB with HIV


infection and other comorbid conditions
38. What is the treatment of HIV
infected TB patients?

TB patients living with HIV infection


should receive the same duration of
TB treatment with daily regimen as
HIV-negative TB patients.

39. How Anti-retroviral therapy and cotrimoxazole prophylactic therapy in


HIV infected TB patients should be
given?

Anti-retroviral therapy must be


offered to all patients with HIV and
TB as well as drug-resistant TB ,
irrespective of CD4 cell-count, as
early as possible (within the first

Pulmonary Communications A quarterly Newsletter of National College of Chest Physicians

eight weeks) following initiation of


anti-TB treatment.

all patients. Minimum records also


be maintained by Private sector.

40. Is there a need of Isoniazid


preventive therapy (IPT) in HIV
patients without active TB?

47. Can the anti TB drugs be bought over


the counter without prescription?

People living with HIV (PLHIV)


should be screened for TB using
four symptom complexes (current
cough or fever or weight loss or night
sweats) at HIV care settings and those
with any of these symptoms should
be evaluated for ruling out active TB.
All asymptomatic patients in whom
active TB is ruled out, Isoniazid
Preventive Therapy (IPT) should be
offered to them for six months.

The Government of India through


a gazette notification has made all
anti-TB drugs under schedule H1.
These drugs should not be dispensed
without a valid prescription from a
qualified practitioner. A copy of the
prescription should be maintained
and details of the patient to be
recorded by the chemist and should
be made available for verification
by the responsible public health
authorities

providers. Every visit of the patient


to the healthcare provider and visit
of the health worker to the patients
home should be utilized for health
education.
Standard 21: Death audit among TB
patients
54. Competent Authorities should audit
which TB deaths?

Every death among TB patients


should be audited by a competent
authority to ascertain preventable
causes.

Standard 22 : Information
prevention and care seeking

on

TB

Standard 11 : Treatment adherence

Standard 15 : Contact investigation

41. How to promote adherence?

48. Which contacts of TB patients be


prioritized for screening of TB?

55. Which group of people should


receive
information
on
TB
Prevention?

Trained treatment supporter which


may include identification and
training of a treatment supporter
(for tuberculosis and, if appropriate,
for HIV, Diabetes Mellitus etc.)
who is acceptable, accessible and
accountable to the patient and to the
health system.

42. What are newer modalities for


promoting treatment adherence?

Use of SMS reminders and call


center linkages between patients,
providers and pharmacists, use of
ICT to promote treatment literacy
and adherence.

Standard 12 : Public health responsibility

Standard 16 : Isoniazid Prophylactic


therapy
49. Who should be considered for IPT?

43. What is the public health


responsibility of a private/Govt.
physician treating tuberculosis?

The practitioner must not only


diagnose as per standard of care
and prescribe an appropriate
regimen, but when necessary, also
utilize local public health services
/ community health services, and
other agencies including NGOs to
assess the adherence of the patient
and to address poor adherence when
it occurs

The highest priority contacts for


active screening are: Persons with
symptoms suggestive of tuberculosis,
Children aged less than six years ,
Contacts with known or suspected
immune-compromise, particularly
HIV infection, Contacts with Diabetes
Mellitus , other higher risks including
pregnancy, smokers and alcoholics
etc. and Contacts of patients with
DR-TB.

Children less than 6 years of age who


are close contacts of a TB patient,
after excluding active TB, should be
treated with isoniazid for a minimum
period of six months and should be
closely monitored for TB symptoms

Standard 17 : Airborne infection control


50.
What
measures
should
be
implemented for Air borne infection
control measures in facilities
treating TB?

Standard 13: Notification of TB cases

Administrative, environmental and


personal protective measures should
be implemented in all health care
facilities as per national airborne
infection control guidelines

44. Since when is the TB a notifiable


disease in India and to whom the
cases should be notified?

51. Which is the most cost effective


infection control measure?

Since 7th May2012 and the cases


should be notified to District Nodal
officer

45. What is the name of electronic


notification system of TB in India?

NIKSHAY

A written record of all medications


given,
bacteriologic
response,
adverse reactions and clinical
outcome should be maintained for

Standard 23 : Free and quality services


56. Which patients should receive free
and quality services?

All patients

Standard 24 : Respect, confidentiality and


sensitivity
57. Health system should be sensitive
to which group of patients?

All people seeking or receiving care


for TB should be received with dignity
and managed with promptness,
confidentiality and gender sensitivity

Standard 25 : Care and support through


social welfare programmes
58. Which social health programmes can
help in supporting the TB patients?

Social welfare support systems


such as RSBY, nutritional support
programmes,
national
rural
employment guarantee scheme etc. to
mitigate out of pocket expenses such
as transport and wage loss incurred
by people affected by TB and post TB
sequelle.

Standard 18: Quality assurance systems

Standard 26: Addressing counseling and


other needs

52. What is covered under Quality


assurance?

59. To whom and at what interval


should counseling be provided?

Standard 14 : Maintain records for all TB


patients
46. What records are to be maintained
for TB patients?

Administrative measures

All individuals especially women,


children, elderly, differently abled,
other vulnerable groups and those
at increased risk should receive
information related to TB prevention
and care seeking.

All diagnostic tests used for diagnosis


and all anti-TB drugs used in the
country are subjected to stringent
quality assurance mechanisms at all
levels (from manufacturer to patients)

Standard 20 : Health education


53. Which patients should be given
counseling?

Every TB symptomatic should be


properly counseled by the healthcare

Persons affected by TB and their


family members should be counselled
at every opportunity, to address
information gaps and to enable
informed decision-making.

60. What issues should be addressed


during counseling?

Counseling should address issues


such as healthcare, physical, financial,
psycho-social and nutritional needs

Pulmonary Communications A quarterly Newsletter of National College of Chest Physicians

Current Status of Non-Invasive Ventilation in Clinical Practice

oninvasive
ventilation
(NIV) refers to the delivery of
mechanical ventilation to lungs
using techniques that do not
require an endotracheal airway ie either
an endotracheal tube or a tracheostomy
tube. The concept of NIV is not new and
the initial ventilators like iron lung were
non- invasive ones. Initially the concept of
non-invasive negative pressure ventilation
(NINPV) was the one which was utilized
for ventilation. In this an iron tank or chest
wrap device was used to create negative
pressure around patients chest wall and
thus helping in ventilation. But NINPV
now almost been given up (except in case of
neuromuscular diseases) and non-invasive
positive pressure ventilation (NIPPV) has
come to an extensive use. Presently the
term NIV is used synonymously with
NIPPV. NIV is being used for an array of
indications and is now a well established
therapy for many respiratory disorders.
Initially NIV was used for hypercapnic
respiratory failure associated with chronic
obstructive airway disease (COPD) but
now it has gained acceptance as first
line ventilation modality for numerous
conditions and clinical indications for
which efficacy of NIV has been proven.
It has become an integral tool in the
management of both acute and chronic
respiratory failure, in both home setting
and in the critical care unit. Currently
it is strongly recommended for acute
hypercapnic respiratory failure due to
COPD, cardiogenic pulmonary edema,
pneumonia in immunocompromised
host and respiratory failure secondary to
neuromuscular disorders. (Table 1)
Table 1. Current evidence to support use
of NIV
1. Level A (Multiple controlled trials)
Chronic obstructive pulmonary disease
Cardiogenic pulmonary edema
Immunocompromised patients
2. Level B (Single controlled trial or
multiple case seires)
Weaning from mechanical ventilation
in COPD patients
Community - acquired pneumonia
(COPD)
Asthma
Postoperative respiratory distress and
respiratory failure
Avoidance of extubation failure
Do not Intubate patients
Neuromuscular respiratory failure
Decompensated obstructive
apnea/cor pulmonale

sleep

3. Level C (Few case series or case reports or failure to demonstrate benefit


in controlled trials )
Cystic fibrosis
Acute respiratory distress syndrome
Community-acquired pneumonia in
non-COPD patients
Upper airway obstruction
Mild Pneumocysis Carnii pneumonia
Trauma

NIV has gained popularity as it offers


many advantages over invasive mechanical
ventilation when used judiciously. It
has lower financial cost, reduced rates of
infections and reduces hospital and ICU
stay. Risks of intubation like tracheal
injuries, stenosis and cardiac arrest during
intubation are also reduced with use
of NIV. It allows gradual weaning and
most patients are able to eat, drink and
communicate while getting ventilation
through NIV and recovering from their
primary illness. It also allows for better
nebulistaion, physiotherapy, mobilisation
and coughing out expectoration. NIV can
also be used for patients who are poor risk
for intubation or who are unwilling for
intubation.
Careful patient selection, appropriate
interface selection, close monitoring
especially in initial few hours and readiness
to intubate as and when required are few
important issues while initiating NIV in
an intensive care setting. The use of NIV
for acute care is not recommended in
settings where immediate intubation is
not feasible. However, NIV should not be
used indiscriminately as it may be harmful
for the patients who require endotracheal
intubation at the outset. It is essential that
NIV is applied in an appropriate clinical
area by appropriately trained staff using
the optimal ventilator mode, settings, and
interface for that patient with adequate
monitoring. An adequate knowledge of
arterial blood gas (ABG) is essential for
NIV use.
The
equipments
required
include
ventilator (or portable machine), tubing,
humidifiers and interface. Several types
of masks are available and a well-fitting
appropriate mask is must. Air leaks from
mask undermine the benefits of NIV. NIV
can be used through ICU ventilators or via
portable NIV machines using appropriate
interfaces. The choice depends upon
availability, the level of support required,
users familiarity and further advantages
and disadvantages of each machine.
Poratable NIV machines have a singlecircuit gas delivery system that has an
intentional leak port to allow exhalation.
They are pressure limited, time and flow
triggered and flow cycled. Most machines
allow for an IPAP from 2 to 30 cm of H2O
while EPAP of 2 to 20 cm H2O. The various
modes in these machines include: CPAP,
spontaneous (S) and S/T (spontaneous/
timed). In CPAP mode patient breathes
spontaneously at a baseline pressure.
The rate and tidal volume delivered is
determined by the patient. In spontaneous
mode, the operator sets IPAP and EPAP,
the gap between two determines the level
of support that will be given to each breath
thus determining tidal volume to a certain
extent. In this mode cycling occurs when
flow reduces to a certain pre-fixed value
usually 40-60%. In S/T mode the operator
has to set a respiratory rate in addition to
IPAP and EPAP. If patient triggers a breath
then it works as a spontaneous mode but
if patient fails to trigger then machine
will give a breath to the assigned IPAP
level. Thus this mode has a backup rate
and is especially useful in patients with
central apnoea, commonly seen in heart
failure. These portable ventilators have

Prof. G.C. Khilnani

Chairman, Critical Care Section, NCCP


Professor in the Department of
Pulmonary Medicine & Critical Care
All India Institute of Medical Science, Delhi
better leak compensation as compared to
adult ICU ventilators. The other important
term to understand in this regard is rise
time ie the time required to reach the
IPAP. Using appropriate rise time control
improves patient comfort and reduces
work of breathing. But these machines
have variable oxygen delivery as delivered
FiO2 depends upon oxygen flow, airflow,
pressure applied and interface. CO2
rebreathing may also occur as these
ventilators have exhalation port in the
mask itself. The washing of exhaled gases
depends upon flow in the circuit, if flow
is low and respiratory rate is high then
rebreathing may occur. At EPAP settings
more than 4 cm H2O the chances of
rebreathing are minimal.
Adult ICU ventilators have an advantage
of delivering desired FiO2 with no chances
of rebreathing and allow better monitoring
especially in acute care setting. In ICU
ventilators, CPAP as well as PSV with a
backup rate can be used but if required
(though seldom) volume-controlled or
pressure controlled ventilation can also be
achieved through NIV interface. In acute
care setting, if available, ICU ventilators
offer advantage of closer monitoring and
are usually preferred. The use of a proper
interface remains the cornerstone to success
of NIV therapy. The various interfaces
available include nasal masks, oronasal
masks, total facemasks, helmets, nasal
pillows and mouthpieces with lip seals. A
correct interface selection ensures patient
comfort and thus improves compliance.
Total face mask covers the entire face and
has less chances of pressure necrosis due
to even pressure distribution all around
the face. Special masks in form of helmet
are also available, it covers entire head
and is secured with straps under armpits.
Recently helmets have been shown to
reduce intubation rates in patients with
ARDS as compared to using face mask.
Mouthpieces and lip seals are also available
and are used mostly in long term NIV
use like in patients with neuromuscular
diseases.
Adequate ventilation and oxygenation
with patient tolerance and comfort are the
primary goals of noninvasive ventilation.
Initial settings should aim at tidal volumes
in the range of 5-7 mL/kg and reduce the
respiratory rate to < 25 breaths/minute.
Oxygen is adjusted to achieve adequate
oxygenation, with a pulse oximetery goal
of greater than 90%. Serial arterial blood
gases measurements should monitor and
guide further adjustments. There is no
recommended protocol for initiation of
NIV but gradually escalating pressures as

Pulmonary Communications A quarterly Newsletter of National College of Chest Physicians

per patients tolerance helps. We should


start with inspiratory positive pressure
(IPAP) of 8 and expiratory positive pressure
(EPAP) of 4. IPAP should be increased by
2 cm water if hypercapnia is persistent.
Increase IPAP and EPAP by 2 cm water if
hypoxemia is persistent. Maximal IPAP is
limited to 20-25 cm water and EPAP to 1015 cm water. Injury to bridge of nose due
continuous pressure leading to facial skin
necrosis may occur in some cases. Ill fitting
mask with significant air leak can lead to
eye irritation and conjunctivitis. Gastric
bloating can be prevented by keeping
IPAP below 25 cm of water. Dry mucus
membranes and thick secretions can occur
in cases with prolonged NIV use without
humidifier.
Patients with respiratory failure should be
carefully selected for NIV. Patients with
respiratory failure in the absence of any
other organ involvement benefit the most.
The current status for recommendations of
NIV is detailed in Table 1. Those selected,
should be able to voluntarily synchronize
respiration with ventilator. NIV is effective
only if patient is able to cooperate. Patient
has to be conscious for being able to
cooperate with NIV but COPD patients
with altered sensorium due to hypercapnia
may be given a trial of NIV for a period
30 to 60 minutes and if the sensorium
improves,NIV may be continued.
Several randomized controlled trials
have proven efficacy of NIV in acute
hypercapnic exacerbation of COPD. It has
been shown to reduce mortality, duration
of hospital in ICU stay and morbidity in
acute exacerbation of COPD. The largest
review concluded that NIV decreased
the intubation rate by 28%, in-hospital
mortality rate by 10%, and absolute
reduction in length of stay by 4.57 days.
The benefit is most pronounced in patients
with more severe COPD exacerbations
with initial pH of less than 7.30. In these
patients intubation rates decreased by
34%, mortality reduction of 12%, and
absolute reduction in the length of hospital
stay was by 5.59 days. Investigations
with less severely affected patients did
not demonstrate benefits in any of these
outcomes.
NIV has also been found to be useful in
patients with cardiogenic pulmonary
oedema. CPAP therapy has been used for
years for treatment of acute cardiogenic
pulmonary edema (ACPE). CPAP helps
in improving oxygenation and improves
lung compliance and reduces intubation
rates. It reduces both preload and afterload
and reduces work of breathing. Multiple
studies have shown similar success
with NIV use especially in patients with
hypercapnia. Current recommendation
is to start CPAP therapy with standard
medical management and start NIV
(Bilevel positive pressure) if patients do
not improve or develop hypercapnia.
In immunocompromised patients (like
solid organ or bone marrow transplant
recipients) pneumonia can be severe
and NIV can be used initially to prevent
intubation as incidence of ventilatorassociated pneumonia is high in this
population and has poor prognosis. In
these patients NIV reduces intubation
rates, mortality and ICU length of stay.
In such patients, if undergoing diagnostic
bronchoscopy, NIV can be used preprocedure and thus preventing intubation.

NIV has been tried in ARDS and acute


lung injury with various out comes and
is a debatable indication.
Multiple
observational studies have suggested
ARDS as a strong predictor of NIV failure.
NIV may be useful in mild ARDS as per
Berlin definition. In patients with shock,
metabolic acidosis and greater hypoxemia
the chances of failure are very high. NIV in
patients with ARDS should be used with
utmost caution as it may increase mortality
if used for longer than necessary leading
to delayed endotracheal intubation. If after
one hour of NIV trial, the PaO2/FiO2 ratio
is less than 15o , then the patient should
be intubated. Recently a randomized trial
using helmet as interface showed reduced
intubation rate with use of NIV. This study
may be a game changer in use of NIV in
patients with ARDS.
NIV has been successfully used in
hypercapnic exacerbation of diseases
other than COPD. In
patients with
bronchiecatsis
having
an
infective
exacerbation NIV may be useful adjunct
to standard medical therapy. Other
diseases like obesity hypoventilation
syndrome and cystic fibrosis may be
treated with NIV during an exacerbation.
NIV is becoming increasingly popular for
prevention and treatment of post-operative
complications. In post lung resection
patients use of NIV (as compared to
mechanical ventilation) reduces atelecatsis
and infections preventing intubations.
Similar findings have been seen in cardiac
surgery patients. In abdominal surgery
patients, NIV improves gas exchange,
reduces atelecatsis and incidence of sepsis
and pneumonia. NIV is commonly used
for management of patients with do-not
intubate instructions. Patients who have a
high risk of complications with intubation
like very old age, severely debilitated
or advanced malignancy are commonly
managed with NIV. NIV may be used
as highest level of care for them or as
palliative measure to treat dyspnea at endof-life. They have good improvement with
NIV but overall survival depends upon
primary illness. NIV or CPAP can be used
during bronchoscopy to prevent procedure
related hypoxemia and intubation. But this
indication needs more studies to have a
better recommendation. During intubation
most patients develop hypoxemia and it
is recommended to pre-oxygenate with
bag and mask. In some patients preoxygenation can not be achieved through
bag and mask even with high FiO2. In
such patients using NIV in a controlled
mode with high FiO2 helps in achieving
better oxygenation prior to intubation.
Restrictive disorders including chest wall
deformities and neuromuscular diseases
result in progressive muscle weakness
which eventually involves respiratory
muscles causing hypoventilation and
eventually respiratory failure. This one
indication of NIV use was earliest to
be studied and continues o be class 1
indication. NIV improves gas exchange
and respiratory muscle function in these
patients thus improving quality of life and
psychosocial function.
NIV is also used as a method of weaning
from invasive mechanical ventilation.
It can be used in three situations in this
aspect:
1. Extubation to NIV after few days of mechanical ventilation (without following
the standard weaning criteria): This in-

dication has not shown any advantage


over standard weaning methods and
thus is not recommended to shorten the
period of invasive mechanical ventilation
2. Extubation to NIV after following standard weaning criteria, to prevent respiratory failure: This approach is useful
to prevent reintubation in high risk
patients which include COPD patients
who remain hypercapnic at the time of
extuabtion.
3. Using NIV as a treatment of post-extubation respiratory failure: This leads to
delay in reintubation and increases ICU
and hospital length of stay and mortality, so currently not recommended.
Conclusion
To summarize, over last two decades,
NIV has emerged as an indispensible
respiratory modality in critical care due
to many advantages over conventional
ventilation. It has an irrefutable role in
the management of acute respiratory
failure supported by many clinical trials.
It is worthwhile to remember that this
modality is not for all patients and should
be used only by trained personnel with
sound knowledge of instrument and
its use. NIV utilization is variable in
different areas with variable knowledge of
indications and use among physician and
intensivists. NIV should be integral part of
care in all ICUs. Proper training of nurses,
physicians and respiratory therapist for
use of NIV is extremely important for
optimum utilization of this modality of
assisted ventilation.
References:
1. Nava S, Hill N: Non-invasive ventilation in acute respiratory failure. Lancet
2009, 374(9685):250-259.
2. Khilnani GC, Banga A: Noninvasive
ventilation in patients with chronic obstructive airway disease. Int J Chron
Obstruct Pulmon Dis 2008, 3(3):351357.
3. Khilnani GC, Saikia N, Banga A, Sharma SK: Non-invasive ventilation for
acute exacerbation of COPD with very
high PaCO(2): A randomized controlled
trial. Lung India, 27(3):125-130.
4. Masip J, Roque M, Sanchez B, Fernandez R, Subirana M, Exposito JA: Noninvasive ventilation in acute cardiogenic pulmonary edema: systematic
review and meta-analysis. Jama 2005,
294(24):3124-3130.
5. Girault C, Bubenheim M, Abroug
F, Diehl JL, Elatrous S, Beuret P, Richecoeur J, L'Her E, Hilbert G, Capellier G et al: Noninvasive ventilation
and weaning in patients with chronic
hypercapnic respiratory failure: a randomized multicenter trial. Am J Respir
Crit Care Med, 184(6):672-679.
6. Ward S, Chatwin M, Heather S, Simonds AK: Randomised controlled
trial of non-invasive ventilation (NIV)
for nocturnal hypoventilation in neuromuscular and chest wall disease patients with daytime normocapnia. Thorax 2005, 60(12):1019-1024.
7. Patel BK, Wolfe KS, Pohlman AS, Hall
JB, Kress JP. Effect of noninvasive
ventilation delivered by helmet vs face
mask on the rate of endotracheal intubation in patients with acute respiratory distress syndrome: a randomized
clinical trial. JAMA. 2016;315(22):24352441.

Pulmonary Communications A quarterly Newsletter of National College of Chest Physicians

Pulmonary Rehabilitation

ulmonary rehabilitation is an
integral part of the clinical
management
and
health
maintenance of those patients with
chronic respiratory disease who remain
symptomatic or continue to have decreased
function despite standard medical
treatment. Pulmonary Rehabilitation (PR)
is a complex multidisciplinary intervention
with variable composition as per needs
and requirements of the respiratory
patient. Components of PR e.g. breathing
techniques, walking exercises, bronchial
hygiene, and respiratory medications
including oxygen have been included for
many centuries as a part of good medical
care.1 In 1974, American Collage of Chest
Physicians gave its name and in 1981,
ATS published first official statement on
PR. Six minute walk test and respiratory
related quality of life questionnaires led to
clinical trails demonstrating effectiveness
in patients particularly in COPD.2 In 1991,
Casaburi demonstrated dose dependent
effect of exercise training on physiological
benefit in COPD and subsequently it was
shown to improve exertional dyspnea.3 In
2001 on the basis of unequivocal impact of
PR in COPD not only on exercise capacity
and QOL but also on subsequent need
for healthcare, it was recommended in
management of COPD in all stages.4 Over
last decade use of PR has been recognized
in non-COPD respiratory conditions with
an aim to reduce symptom of dyspnea.5
Also as physical inactivity is related
to shortened survival and recurrent
hospitalizations, PR targets in improving
activity with collateral benefit.
Definitio n of Pulmonary
rehabilitation
In 2013, ATS/ERS statement on PR is
closest to workable definition of PR. Its
a comprehensive intervention based on
a thorough patient assessment followed
by patient tailored therapies, which
include, but are not limited to, exercise
training, education and behavioral
change, designed to improve physical
and emotional condition of persons
with chronic respiratory disease and
to promote the long term adherence to
health enhancing behaviors5. In short, PR
is a entity on its own though it combines
different therapies delivered by different
professionals with relevant expertise
e.g. respiratory physician, respiratory
therapist, dietician, education counselor,
exercise physiologist, etc. also, PR as
intervention is given to the patient at
multiple times in disease trajectory of
chronic lung disease.

Promote autonomy
Increase participation in everyday
activities
Decrease psychological symptoms
Improve health-related quality of life
Effectuate long-term 1health-enhancing
behavior change
Pulmonary Rehabilitation
Team
Pulmonary rehabilitation is implemented
by a dedicated, interdisciplinary team,
which includes generally following
specialists depending upon availability
and resource utilization:7
Respiratory Physicians
Exercise physiologists
Respiratory therapists
Physiotherapists
Psychologists / behavioral specialist
Nutritionists
Occupational therapists
Social workers
Patient Educator or Nurse practitioner
Resources and availability of health care
professionals limit most of PR programs
and hence, some of the teammates play
dual or more roles to fill in for nonavailable staff members.
Indications and
Contraindications of
Pulmonary Rehabilitation
Although conventionally any COPD
patient who is symptomatic is to be
referred to PR but indications are
broadening with more research in this
area with beneficial effects being reported
in patients beyond COPD.
Pragmatic approach would be to refer
any patient with persistent respiratory
symptoms e.g. dyspnea, fatigue and / or
functional impairment despite optimized
available therapy and hence to restricting

Dr. Deepak Talwar

Director & Chair, Pulmonary,


Sleep & Critical Care Medicine,
Metro Group of Hospitals, Noida

Dr. Mir Shad Ali

Head Pulmonary Rehabilitation &


Exercise Lab, Metro Center for
Respiratory Diseases, Noida
to COPD or Obstructive lung disease.
Patients with restrictive lung diseases
secondary to any cause including ILD
with above said clinical indications
should also be referred to PR.8
Complementing these general
recommendations, there are indications
where PR should be prescribed without
any hesitation i.e. patients recently
discharged from hospital with COPD-AE
and patients with MRC grade 3 dyspnea
or greater regardless of lung functions
impairment
Broadly absolute contraindication would
be a completely demotivated patient or
if exercise would be painful / potentially
dangerous, but still risk versus benefit
should be considered in each such case.
Co morbidities are no longer considered
as CI to PR and adaptation in PR may
be required to address such issues e.g
depression or anxiety by incorporating
psychiatrist or psychologist or associate
CAD requiring physician for assessment
and planning. Other concurrent
conditions which may interfere with PR
process or places patient at substantial
risk during exercise should be stabilized
prior to taking them in PR.1

Table 1: Indications and contraindications of pulmonary rehabilitation


INDICATIONS

CONTRAINDICATIONS

Persistent respiratory symptoms,


especially dyspnea

Conditions that substantially increase risk


during rehabilitation, e.g., unstable angina

Limitation of functional status despite


optimal medication

Conditions that substantially interfere


with rehabilitative process

Impaired health related quality of life

Uncontrolled diabetes

Decreased occupational performance

Psychiatric illness, e.g. Dementia

Goals of Pulmonary
Rehabilitation

Psychosocial problems attendant on the


underlying respiratory illness

Severe exercise-induced hypoxemia, not


correctable with oxygen supplementation

The goals of PR are dependent on patients


needs depending upon functional
limitations and disabilities and hence
have to be individualized for each
patient6. The main goals are to:

Difficulty with medical regimen

Inability to exercise due to orthopaedic or


other reasons

Minimize symptom burden

Increased use of medical resources

Maximize exercise performance

Gas exchange abnormalities

Difficulty performing day-to-day activities


Nutritional depletion

Pulmonary Communications A quarterly Newsletter of National College of Chest Physicians

Patient Selection in
Pulmonary Rehabilitation
This depends upon the patients who are
likely to benefit from PR and since results
of rehabilitation may improve many
dimensions, patient referral will vary.
As improvement in exercise capacity is
major positive outcome, any respiratory
patient who is breathlessness on exertion,
would be an ideal candidate for PR but
challenge is to identify responders, which
too will vary at different dimensions.9
Patients with reduction in functional
capacity, quality of life or occupational
/ daily activities related performance,
may indicate good responders as clear
and achievable goals are known prior to
initiation of PR. Generally, patients with
pre existing skeletal muscle weakness,
poor exercise capacity with better
ventilator parameters and are relatively
young, do better in PR.10 These points are
useful as PR is labor intensive and time
consuming with financial implications.
Patient Assessment in
Pulmonary rehabilitation
At the begining of PR, its crucial to have
patient-physician interaction with clear
dialogue where patient is to be clarified
about limitations of pharmacotherapy
and goals to be set by chest physician
on the basis of expectations by the
patient and realistic outcomes possible
as per the current knowledge of PR.
Patient assessment is ongoing process
& done even if done on previous visits.
Complete assessment of patient begins
with checking medical history with
particular reference to respiratory as
well as neuromuscular and orthopedic
problems, comorbidities, smoking
or other addictions as they may pose
challenge during PR.11 Baseline literacy,
hearing, vision and cognitive ability
requires to be looked into as these would
influence outcomes of PR. Symptom
assessment of dyspnea, fatigue, cough,
chest pain or sputum allows PR team
to know the burden of disease to set
outcome expectations. Medication history
is needed not only to see if its optimized
to the disease but also if any special care
in PR to be provided e.g. corticosteroids,
bronchodilators or diuretics, insulin, etc.

Physical examination findings of


respiratory distress, breathing pattern and
oxygenation status is to be recorded as
would need to be addressed during PR.
Diagnostic tests results to be reviewed
include spirometry, oximetry both at rest
as well as at walk, CXR and if available
6 minute walk test or cardio-pulmonary
exercise test report. Its important to note
BMI, Serum albumin, fluids intake or
restrictions and detailed dietary history
with Fat free mass estimation to target
skeletal muscle strengthening in PR and
baseline EKG and ECHO to know cardiac
limitations during PR if any. Exercise
capacity assessment include physical
limitations if any, gait and balance,
exercise tolerance and related hypoxia,
etc factors which would influence exercise
training plan in PR. Pain chest, limbs, or
back is also worth noting as may become
limiting factors in exercise programme.
Finally a breif history of activities of
daily living with reference to functional
task performance e.g. bathing, washing,
changing clothes, leisure activities and
use of supplemental oxygen during day to
day work. Some PR programmes include
questionares (SGRQ, SF36, Bode Index
etc) at baseline to document improvement
at the end of the program. Anxiety or
depression assessment using simple
questionaires (PHQ-2 and 3) are included
to identify any significant psychological
imapirment which would require special
assisstance.
At the end of this global assessment,
depending upon rehabilitation potential
PR team formulates goals both short
term as well as long term which are
individulaized, measurable, patient
centred and realistic and being graded
from Excellent to Poor.12
Its suffice to say that such exhaustive
assessment would need multidisciplinary
team work and cordination as everything
needs to be done in limited time with
limited discomfort to the patient
Components of Pulmonary
Rehabilitation:
Pulmonary rehabilitation is not exercise
training as includes many other aspects to
improve overall functional capacity of the

Figure 1: Showing various assessments required prior to


initiation of pulmonary rehabilitation in an individual patient.

10

patients. A good PR program includes,


optimized medications and delivery,
smoking cessation, education about
disease and prognosis, self management
plan for AE and daily situations,
nutritional support, energy conservation
techniques, psychological counseling,
behavior change, ADL training, home
adaptation and aids, oxygen and NIV
therapy, mucus handling and bronchial
hygiene, hormonal supplements,
inspiratory muscle training, etc.12
Duration of Pulmonary
Rehabilitation Program
Ideally rehabiliation should continue as
long as gains are being made. There is
no concensus on optimal duration of PR
but its ideally set by continued progress
towards goals and optimization of benefit.
In reality its also influenced by finacial
resources and traveling burden. Generally
longer programs are considered to
produce greater gains and maintenance
of benefits achieved on short term. But
a minimum of 8 weeks is recommended
to gain substantial benefit.5 Our study
showed that as short as 3 weeks after
discharge from hospital for COPD AE
is effective considering difficulties in
sustaining long term programs.13 Also,
length of PR is also dependent on the
setting i.e. hospital based, community
based or home based and if one can be
followed by the other as per convience
and teams decisions. Two to three visits
per week are recommended during PR.
Location and Settings of
Pulmonary Rehabilitation
Although programs have been
conventionally developed where
patient visits PR center in the hospital
or clinic 2 or 3 times a week but PR has
been shown to be effective inpatient
settings too. Recently sucessful PR
programs have demonstrated to be
delivered in other settings e.g. primary
care (physiotherapists clinic), home
or secondary care (community or
nursing homes) and systemic review
has confirmed beneficial effects of home
based PR14 but such programs are to be
considered for most severely disabled
provided supervision by experts is
available which is rare.

Figure 2: Essential components of pulmonary rehabilitation


indicating that PR is not a exercise program alone but has many
other facets.

Pulmonary Communications A quarterly Newsletter of National College of Chest Physicians

Compliance to Pulmonary
rehabilitation
As with any therapy in medicine long
term compliance rate are not excellent
in PR also. Nearly 23% drop outs are
reported with primary issues related
to travel, familiy, finances or due to
exacerbations or hospitalization related
to primary disease or unrelated helath
problems.15
Exercise Training in
Pulmonary Rehabilitation
This is one of the most important
component of PR and is based on
following principles :
Intensity: Higher intensity produces
greater results(e.g, > 60% of VO2MAX
or at 60% TO 80% Wmax)5
Specificity: Only muscles
produce the desired effect

trained

Reversibility: Stopping regular exercise


training decreases the effect
Exercise regimen is to
endurance, strength or both.

improve

Duration, frequency, mode and intensity


of exercise prescription is based on
severity of disease, degree of conditioning
and initial exercise capacity.16 Aerobic
Endurance training whether given as
high or low intensity would improve
patients ability to perform activities
which require continous effort for long
periods e.g. walking and optimal exercise
paln would include cycle ergometry
and treadmill walking. Generally biking
induces less exercise induced hypoxia and
hence more suitable for hypoxic patients.
Interval tarining is an option for those
who can not sustain extended continous
high intensity exercise in the form of rest
periods in between or alternating periods
of high and low intensity exercises.
Strength or Resistance training is used
for explosive activities which require
excessive strength in bursts for short
period of time e.g. sprinting, jumping
and lifting weights. Exercise targets local
muscle groups with reduced mass and
strength of peripheral muscles required to
perform these activities and as collateral
benefit improves bone mineral density.
This training improves muscle mass and
results in improved exercise tolerance as
patient experiences less dyspnea. Training
is done using free weights, squating, stair
climbing,elastic resistive bands, machine
weights or simply repeated sit and stand
from chair. Lesser weights and more
repitions improves endurance and higher
weights with fewer repetitions improve
muscle mass.17
Exercise plan targets both upper and
lower limb muscles as upper limb muscles
are required for daily activities like

dressing bathing and performing house


hold activities while lower limbs muscle
dysfunction is main cause of exercise
limitation in respiratory patients and
provides best physiological gains in PR.
Inspiratory muscle training (IMT)is
needed as there weakness leads to more
perception of dypnea and hence imapired
exercise tolerance. Training includes
voluntary isocapnic hperventilation,
inspiratory threshold or resistive
loading. This is more useful if patient has
undelying COPD or reduced respirstory
muscle strength demonstrated by
measurement of maximum inspiratory
pressures.18
Nutritional Support in
Pulmonary Rehabilitation
Weight as well as Fat Free Mass
(FFM) estimates of the patient
needs consideration in PR. Caloric
supplementation is provided to meet the
extra demands for energy from PR and
if any deficit pre existing (BMI < 21).19
Iindian guidelines also recommend to
monitor BMI periodically to see the effect
of nutritional support as it has also been
shown to improve QOL
Psychological Support in
Pulmonary Rehabilitation
Prevalance of anxiety and depression
in COPD is 36% and 40% respectively20
and depression is known to increase the
risk of AE and hospitalizations in COPD.
Patient may be provided with vocational
counselling, education strategies to
cope stress and involvement of family
members to resove conflicts. However
patients with severe psychological
problems need formal evaluation by
psychiatrist.
Education in Pulmonary
Rehabilitation
Patient education is an important part of
PR and topics includes but not limited
to them are, normal lungs structure
and function, disease aspects, smoking
cessation, avoidance of potential risk
factors of irritants and allergens, clearanc
eof secretions, Energy conservation
techniques, appropriate inhaler
technique,breathing strategies, benfits
of drugs prescribed and compliance,
recognition of worsening of disease and
intial self management plan.21

Long Term Maintenace


of Benefits of Pulmonary
rehabilitation
Benfits appear to diminish over 6 -12
months after discontinuation of PR. And
is due to :
Decrease in treatment adherence,
especially to long-term regular exercise
Progression of underlying disease
Development of co-morbidities
Acute exacerbations
Benefits can be maintained by establishing
ongoing communication of the patient
with PR team through:
Weekly telephone calls and monthly
reinforcement visits
Weekly supervised outpatient-based
exercise plus unsupervised home
exercise23
Pulmonary Rehabilitation:
Future Directions
PR addresses the systemic effects of
chronic respiratory disease, which are
complex and involve peripheral muscle
dysfunction. Although in COPD role of
PR has been established beyond doubt
and has been shown to be far superior
to any other therapy at patient oriented
multiple outcome areas, its role is in other
chronic respiratory diseases is evolving.
Recently role of PR has been extended
from stable patients to patients in
hospitals and immediately after discharge
while being traeted for exacerbation. PR
has also been recommeded early in critical
illness with neuromuscular stimulation
started in mechanically ventilated
patients.24 Also data from pooled clinical
trials in COPD showed that physical
inactivity is also reported in mild and
early COPD, PR is being recommended in
these patients also. Realizing difficulties
of traveling to PR centers, home bases and
community based programs are being
developed to circumvent these problems
and extend benefit to many more patients.
Also, internet and telemonitoring has
advanced scope of PR futher where it can
be assissted remotely.
References
1. Casaburi RA. Brief history of pulmonary rehabilitation. Respir Care 2008;
53:1185-9

Outcome Assessment of
Pulmonary Rehabilitation

2. ZuWallack RA. History of pulmonary


rehabilitation back to future. Pneumonol
Alergol Pol 2009; 77:298-301

Outcome of PR is done either on real


time or during the course of the program
or at the end of the program by recall.
Generally QOL, dyspnea indices and
functional status parameters ( 6 MWT,
BODE index, CAT, etc ) are evaluated.22

3. Casaburi R, Patessio A., Ioli F. et al. Reduction in exercise Lactic acidosis and
ventilation as a result of exercise training in patients with obstructive lung
disease. Am Rev Respir Dis 1991; 143:918

Pulmonary Communications A quarterly Newsletter of National College of Chest Physicians

11

4. Griffiths TL, Phillips CJ, Davies S, et al.


Cost effectiveness of an outpatient multidisciplinary pulmonary rehabilitation
program. Thorax 2001; 56:779-84

ties on the outcomes of pulmonary rehabilitation programs in patients with


COPD; a systematic review. Biomed Res
Int 2013; 2013:146148

5. Spruit MA, Singh SJ, Garvey C, et al.


Key concepts and advances in pulmonary rehabilitation based on the official
2013 American thoracic Society/European Respiratory Society statement on
pulmonary rehabilitation. Amer J respire
Crit Care Med 2013; 188:e13-64.

12. Parshall MB, Schwartzstein RM, Adams


L, et al. An official American Thoracic
statement: update on the mechanisims,
assessment and management of dyspnea. Am J Respir Crit Care Med 2012;
185:435-52

6. American Association of Cardiovascular and Pulmonary Rehabilitation.


Guidelines for pulmonary rehabilitation programs, 3rd. Ed. 2004. Available
at: www.HumanKinetics.com
7. Spruit MA, Pitta F, Garvey C, et al. Differences in content and organizational
aspects of pulmonary rehabilitation
programs. Eur Respir J 2014; 43:1326-37
8. Bolton CE, Bevan-Smith EF, Blakey JD,
et al. British Thoracic Society guidelines
on pulmonary rehabilitation in adults.
Thorax 2013; 68:ii1-30
9. Young P, Dewse M, Fergusson W, et al.
Respiratory rehabilitation in chronic
obstructive pulmonary disease : predictors of nonadherance. Eur Respir J 1999;
13:855-9.
10. ZuWallack RL. Selection criteria and
outcome assessment in pulmonary rehabilitation. Monaldi Archives for Chest
Dis 1998; 53:429-437.
11. Hornikx M, Van Remoortel H, Demeyer H, et al. The influence of co morbidi-

13. Ali MS, Talwar D and Jain SK. The Effect of a Short- Term Pulmonary Rehabilitation on Exercise Capacity and
Quality of Life in Patients Hospitalised
with Acute Exacerbation of Chronic
Obstructive Pulmonary Disease. Indian
J Chest Dis Allied Sci 2014; 56:13-19
14. Mendes de Oliveriera JC, Studart Leitao
Filho FS, Malosa Sampaio LM, et al.
Outpatient vs home based pulmonary
rehabilitation in COPD: a randomized
controlled trial. Multidiscip Respir med
2010; 5:401-8
15. Nici L. Adherence to a pulmonary rehabilitation program: start by understanding the patient. COPD 2012; 9:44557
16. Puhan MA, Schunemann HJ, Frey M,
et al. How should COPD patients exercise during respiratory rehabilitation ?
Comparison of exercise modalities and
intensities to treat skeletal muscle dysfunction. Thorax 2005; 60:367-75
17. Gloecki R, Marinov B, Pitta F, et al.
Practical recommendations for exercise

Welcome
Faculty &
Delegates
NAPCON -2016
Dr. Rajesh Chawla Dr. S. N. Gaur
President
NCCP (India)

12

Secretary
NCCP (India)

training in patients with COPD. Eur


Respir Rev 2013; 22:178-86
18. Smith K, Cook D, Guyatt GH, et al. Respiratory muscle training in chronic
airflow limitation: a meta-analysis. Am
Rev Respir Dis 1992; 145:533-9
19. Debigare R, Marquis K, cote CH, et al.
Catabolic/anabolic balance and muscle
wasting in patients with COPD. Chest
2003; 124:83-9.
20. Maurer J, Rebbapragada V, Borson S,
et al. Anxiety and depression in COPD:
current understanding, unanswered
questions, and research needs. Chest
2008; 134:43S-56S
21. Monninkhof E, van der Valk P, van der
Palen J, et al. Self management education for patients with chronic obstructive pulmonary disease:a systematic
review. Thorax 2003; 58:394-8.
22. Mahler DA, and Jones PW. Measurement of dyspnea and quality of life in
advanced Lung disease. Clin Chest Med
1997; 18:457-469.
23. Reis AL, Kaplan RM, Myers R, et al.
Maintenance after pulmonary rehabilitation in chronic lung disease; a randomized trial. Am J Respir Crit Care Med
2003; 167:880-8
24. Rochester CL. Rehabilitation in the intensive care unit. Semin Respir Crit Care
Med 2009; 30:656-69.

KOCHI CRITICARE 2017


23rd Annual Conference of Indian
Society of Critical Care Medicine
Come! Witness the modern techniques to treat
your Critical Patients in a better way.

Workshop : 1st, 2nd February 2017


Conference : 3rd, 4th, 5th February 2017

Venue : Le. Meridean Convention Centre


Thomas Mathew

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(Scientific committee Chairman)

Mob. : 9447076652

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Pulmonary Communications A quarterly Newsletter of National College of Chest Physicians

Journal Scan
Efficacy and safety of benralizumab
for patients with severe asthma
uncontrolled with high-dosage inhaled
corticosteroids and long-acting 2agonists (SIROCCO): a randomised,
multicentre, placebo-controlled phase 3
trial.
Bleecker ER, FitzGerald JM, Chanez P, Papi
A et al SIROCCO study

Lancet. 2016 Sep 2. pii: S0140-6736(16)31324


Eosinophilia is associated with worsening
asthma severity and decreased lung
function, with increased exacerbation
frequency. This study assessed the safety
and efficacy of benralizumab, a monoclonal
antibody against interleukin-5 receptor
that depletes eosinophils by antibodydependent cell-mediated cytotoxicity, for
patients with severe, uncontrolled asthma
with eosinophilia.
This randomised, double-blind, parallelgroup, placebo-controlled phase 3 study
was done at 374 sites in 17 countries.
They recruited patients (aged 12-75
years) with a physician-based diagnosis
of asthma for at least 1 year and at least
two exacerbations while on high-dosage
inhaled corticosteroids and long-acting2agonists (ICS plus LABA) in the previous
year. Patients were randomly assigned
(1:1:1) by an interactive web-based voice
response system to benralizumab 30 mg
either every 4 weeks (Q4W) or every 8
weeks (Q8W; first three doses every 4
weeks) or placebo Q4W for 48 weeks
as add on to their standard treatment.
Patients were stratified 2:1 according to
blood eosinophil counts of at least 300
cells perL and less than 300 cells perL.
All patients and investigators involved in
patient treatment or clinical assessment
were masked to treatment allocation. The
primary endpoint was annual exacerbation
rate ratio versus placebo, and key secondary
endpoints were pre bronchodilator forced
expiratory volume in 1 s (FEV1) and total
asthma symptom score at week 48, for
patients with blood eosinophil counts of
at least 300 cells perL. Efficacy analyses
were by intention to treat (based on the
full analysis set); safety analyses included
patients according to study drug received.
Between Sept 19, 2013, and March 16,
2015, 2681 patients were enrolled, 1205
of whom met the study criteria and
were randomly assigned: 407 to placebo,
400 to benralizumab 30 mg Q4W, and
398 to benralizumab 30 mg Q8W. 267

patients in the placebo group, 275 in the


benralizumab 30 mg Q4W group, and 267
in the benralizumab 30 mg Q8W group
had blood eosinophil counts at least 300
cells perL and were included in the
primary analysis population. Compared
with placebo, benralizumab reduced the
annual asthma exacerbation rate over 48
weeks when given Q4W (rate ratio 0.55,
95% CI 0.42-0.71; p<0.0001) or Q8W (0.49,
0.37-0.64; p<0.0001). Both benralizumab
dosing regimens significantly improved
prebronchodilator FEV1 in patients at
week 48 compared with placebo (leastsquares mean change from baseline: Q4W
group 0.106 L, 95% CI 0.016-0.196; Q8W
group 0.159 L, 0.068-0.249). Compared
with placebo, asthma symptoms were
improved by the Q8W regimen (leastsquares mean difference -0.25, 95% CI -0.45
to -0.06), but not the Q4W regimen (-0.08,
-0.27 to 0.12). The most common adverse
events were worsening asthma (105 [13%]
of 797 benralizumab-treated patients vs 78
[19%]of 407 placebo-treated patients) and
nasopharyngitis (93 [12%]vs 47 [12%]).

75 years with severe asthma uncontrolled

These results confirm the efficacy and


safety of benralizumab for patients with
severe asthma and elevated eosinophils,
which are uncontrolled by high-dosage
ICS plus LABA, and provide support for
benralizumab to be an additional option to
treat this disease in this patient population.

Between Aug 21, 2013, and March 16,

by medium-dosage to high-dosage inhaled


corticosteroids plus long-acting-agonists
(ICS plus LABA) and a history of two or
more exacerbations in the previous year.
Patients were randomly assigned (1:1:1) to
receive 56 weeks of benralizumab 30 mg
every 4 weeks (Q4W), benralizumab 30
mg every 8 weeks (Q8W; first three doses 4
weeks apart), or placebo (all subcutaneous
injection). Patients were stratified (2:1) by
baseline blood eosinophil counts 300 cells
perL or greater and less than 300 cells
perL, respectively. Patients and study
centre staff were masked to treatment
allocation. The primary endpoint was
annual exacerbation rate ratio versus
placebo for patients receiving high-dosage
ICS plus LABA with baseline blood
eosinophils 300 cells perL or greater
(intention-to-treat analysis). Key secondary
endpoints were pre-bronchodilator forced
expiratory volume in 1 s (FEV1) and total
asthma symptom score. This study is
registered with ClinicalTrials.gov, number
NCT01914757.
2015, 2505 patients were enrolled, of
whom 1306 patients were randomised;
425 patients were randomly assigned to
and received benralizumab 30 mg Q4W,
441 to benralizumab 30 mg Q8W, and 440
to placebo. 728 patients were included
in

Benralizumab, an anti-interleukin-5
receptormonoclonal antibody, as addon treatment for patients with severe,
uncontrolled, eosinophilic asthma
(CALIMA): a randomised, double-blind,
placebo-controlled phase 3 trial.
FitzGerald JM, Bleecker ER, Nair P et al
CALIMA study investigators
Lancet. 2016 Sep 5. pii: S0140-6736(16)31322
8
Benralizumab is a humanised, afucosylated,
anti-interleukin-5 receptormonoclonal
antibody that induces direct, rapid, and
nearly complete depletion of eosinophils.
This study aimed to assess the efficacy and
safety of benralizumab as add-on therapy
for patients with severe, uncontrolled
asthma and elevated blood eosinophil
counts.
In this randomised, double-blind, parallelgroup, placebo-controlled, phase 3 study
(CALIMA) undertaken at 303 sites in 11
countries, They enrolled patients aged 12-

the

primary

analysis

population.

Benralizumab resulted in significantly


lower annual exacerbation rates with the
Q4W regimen (rate 0.60 [95% CI 0.48-0.74],
rate ratio 0.64 [95% CI 0.49-0.85], p=0.0018,
n=241) and Q8W regimen (rate 0.66 [95% CI
0.54-0.82], rate ratio 0.72 [95% CI 0.54-0.95],
p=0.0188, n=239) compared with placebo
(rate 0.93 [95% CI 0.77-1.12], n=248).
Benralizumab also significantly improved
pre-bronchodilator FEV1 (Q4W and Q8W)
and total asthma symptom score (Q8W
only) in these patients. The most common
adverse events were nasopharyngitis (90
[21%] in the Q4W group, 79 [18%]in the
Q8W group, and 92 [21%]in the placebo
group) and worsening asthma (61 [14%]
in the Q4W group, 47 [11%]in the Q8W
group, and 68 [15%]in the group).
Benralizumab
annual

significantly

exacerbation

rates

reduced
and

was

generally well tolerated for patients with


severe, uncontrolled asthma with blood
eosinophils 300 cells perL or greater. Their
data further refine the patient population

Pulmonary Communications A quarterly Newsletter of National College of Chest Physicians

13

likely to receive the greatest benefit from


benralizumab treatment.

Effect of Postextubation High-Flow


Nasal Cannula vs Conventional Oxygen
Therapy on Reintubation in Low-Risk
Patients: A Randomized Clinical Trial.
Hernndez G, Vaquero C, Gonzlez P et al
JAMA. 2016;315(13):1354
Studies of mechanically ventilated critically
ill patients that combine populations that
are at high and low risk for reintubation
suggest that conditioned high-flow nasal
cannula oxygen therapy after extubation
improves oxygenation compared with
conventional oxygen therapy.
To determine whether high-flow nasal
cannula oxygen therapy is superior
to conventional oxygen therapy for
preventing reintubation in mechanically
ventilated patients at low risk for
reintubation.
Multicenter randomized clinical trial
conducted between September 2012
and October 2014 in 7 intensive care
units (ICUs) in Spain. Participants were
527 adult critical patients at low risk
for reintubation who fulfilled criteria
for planned extubation. Low risk for
reintubation was defined as younger than
65 years; Acute Physiology and Chronic
Health Evaluation II score less than 12 on
day of extubation; body mass index less
than 30; adequate secretions management;
simple weaning; 0 or 1 comorbidity; and
absence of heart failure, moderate-tosevere chronic obstructive pulmonary
disease, airway patency problems, and
prolonged mechanical ventilation.
Patients were randomized to undergo
either high-flow or conventional oxygen
therapy for 24 hours after extubation.
The primary outcome was reintubation
within 72 hours, compared with the CochranMantel-Haenszel2
test.
Secondary
outcomes
included
postextubation
respiratory failure, respiratory infection,
sepsis and multiorgan failure, ICU and
hospital length of stay and mortality,
adverse events, and time to reintubation.
Of 527 patients (mean age, 51 years [range,
18-64]; 62% men), 264 received high-flow
therapy and 263 con ventional oxygen
therapy. Reintubation within 72 hours
was less common in the high-flow group
(13 patients [4.9%]vs 32 [12.2%]in the
conventional group; absolute difference,
7.2% [95% CI, 2.5% to 12.2%]; P=.004).

14

Postextubation respiratory failure was less


common in the high-flow group (22/264
patients [8.3%]vs 38/263 [14.4%]in the
conventional group; absolute difference,
6.1% [95% CI, 0.7% to 11.6%]; P=.03).
Time to reintubation was not significantly
different between groups 19 hours
[interquartile range, 12-28]in the high-flow
group vs 15 hours [interquartile range,
9-31]in the conventional group; absolute
difference, -4 [95% CI, -54 to 46]; P=.66].
No adverse effects were reported.
Among extubated patients at low risk
for reintubation, the use of high-flow
nasal cannula oxygen compared with
conventional oxygen therapy reduced the
risk of reintubation within 72 hours.

Effect of Hydrocortisone on
Development of Shock Among Patients
With Severe Sepsis: The HYPRESS
Randomized Clinical Trial.
Keh D, Trips E, Marx G, Wirtz SP et al
JAMA 2016 Nov;316(17):1775-1785
Adjunctive
hydrocortisone
therapy
is suggested by the Surviving Sepsis
Campaign in refractory septic shock only.
The efficacy of hydrocortisone in patients
with severe sepsis without shock remains
controversial.
This study was done to determine whether
hydrocortisone therapy in patients with
severe sepsis prevents the development of
septic shock.
This study was double-blind, randomized
clinical trial conducted from January 13,
2009, to August 27, 2013, with a follow-up
of 180 days until February 23, 2014. The
trial was performed in 34 intermediate
or intensive care units of university and
community hospitals in Germany, and it
included 380 adult patients with severe
sepsis who were not in septic shock.
Patients were randomly allocated 1:1 either
to receive a continuous infusion of 200 mg
of hydrocortisone for 5 days followed by
dose tapering until day 11 (n=190) or to
receive placebo (n=190).
The primary outcome was development
of septic shock within 14 days. Secondary
outcomes were time until septic shock,
mortality in the intensive care unit or
hospital, survival up to 180 days, and
assessment of secondary infections,
weaning failure, muscle weakness, and
hyperglycemia (blood glucose level>150
mg/dL [to convert to millimoles per liter,
multiply by 0.0555]).

The
intention-to-treat
population
consisted of 353 patients (64.9% male;
mean [SD]age, 65.0 [14.4]years). Septic
shock occurred in 36 of 170 patients
(21.2%) in the hydrocortisone group and
39 of 170 patients (22.9%) in the placebo
group . No significant differences were
observed between the hydrocortisone and
placebo groups for time until septic shock;
mortality in the intensive care unit or in
the hospital; or mortality at 28 days .In the
hydrocortisone vs placebo groups, 21.5%
vs 16.9% had secondary infections, 8.6% vs
8.5% had weaning failure, 30.7% vs 23.8%
had muscle weakness, and 90.9% vs 81.5%
had hyperglycemia.
Among adults with severe sepsis not
in septic shock, use of hydrocortisone
compared with placebo did not reduce
the risk of septic shock within 14 days.
These findings do not support the use of
hydrocortisone in these patients.

Effect of Noninvasive Ventilation


Delivered by Helmet vs Face Mask on
the Rate of Endotracheal Intubation in
Patients With Acute Respiratory Distress
Syndrome: A Randomized Clinical Trial.
Patel BK, Wolfe KS, Pohlman AS, Hall JB,
Kress JP
JAMA. 2016;315(22):2435.
Noninvasive ventilation (NIV) with a face
mask is relatively ineffective at preventing
endotracheal intubation in patients with
acute respiratory distress syndrome
(ARDS). Delivery of NIV with a helmet
may be a superior strategy for these
patients.
The objective of this study was to
determine whether NIV delivered by
helmet improves intubation rate among
patients with ARDS.
This was a single-center randomized
clinical trial of 83 patients with ARDS
requiring NIV delivered by face mask
for at least 8 hours while in the medical
intensive care unit at the University of
Chicago between October 3, 2012, through
September 21, 2015.
Patients were randomly assigned to
continue face mask NIV or switch to a
helmet for NIV support for a planned
enrollment of 206 patients (103 patients per
group). The helmet is a transparent hood
that covers the entire head of the patient
and has a rubber collar neck seal. Early
trial termination resulted in 44 patients
randomized to the helmet group and 39 to
the face mask group.

Pulmonary Communications A quarterly Newsletter of National College of Chest Physicians

The primary outcome was the proportion


of patients who required endotracheal
intubation. Secondary outcomes included
28-day invasive ventilator-free days (ie,
days alive without mechanical ventilation),
duration of ICU and hospital length of
stay, and hospital and 90-day mortality.

intention-to-treat analysis cohort.

has not been validated in clinical practice.

Intervention included administration of


aspirin, 325-mg loading dose followed
by 81 mg/d (n=195) or placebo (n=195)
within 24 hours of emergency department
presentation and continued to hospital
day 7, discharge, or death.

This study was done to assess whether


a conservative protocol for oxygen
supplementation could improve outcomes
in patients admitted to intensive care units
(ICUs).

Eighty-three patients (45% women; median


age, 59 years; median Acute Physiology
and Chronic Health Evaluation [APACHE]
II score, 26) were included in the analysis
after the trial was stopped early based
on predefined criteria for efficacy. The
intubation rate was 61.5% (n=24) for the
face mask group and 18.2% (n=8) for the
helmet group (absolute difference, -43.3%;
P<.001). The number of ventilator-free
days was significantly higher in the helmet
group (28 vs 12.5, P<.001). At 90 days, 15
patients (34.1%) in the helmet group died
compared with 22 patients (56.4%) in the
face mask group (absolute difference,
-22.3%; 95% CI, -43.3 to -1.4; P=.02).
Adverse events included 3 interfacerelated skin ulcers for each group (ie, 7.6%
in the face mask group had nose ulcers and
6.8% in the helmet group had neck ulcers).

The primary outcome was the development


of ARDS by study day 7. Secondary
measures included ventilator-free days,
hospital and intensive care unit length
of stay, 28-day and 1-year survival, and
change in serum biomarkers associated
with ARDS. A finallevel of .0737 (=.10
overall) was required for statistical
significance of the primary outcome.

This study was among patients with ARDS,


treatment with helmet NIV resulted in a
significant reduction of intubation rates.
There was also a statistically significant
reduction in 90-day mortality with helmet
NIV. Multicenter studies are needed to
replicate these findings.

Effect of Aspirin on Development of


ARDS in At-Risk Patients Presenting to
the Emergency Department: The LIPS-A
Randomized Clinical Trial.
Kor DJ, Carter RE, Park PK, et al: Lung Injury Prevention with Aspirin Study
JAMA. 2016;315(22):2406.
Management of acute respiratory distress
syndrome (ARDS) remains largely
supportive. Whether early intervention
can prevent development of ARDS remains
unclear.
The objective of this study was to evaluate
the efficacy and safety of early aspirin
administration for the prevention of ARDS.
This multicenter, double-blind, placebocontrolled, randomized clinical trial was
conducted at 16 US academic hospitals.
Between January 2, 2012, and November
17, 2014, 7673 patients at risk for ARDS
(Lung Injury Prediction Score4) in the
emergency department were screened and
400 were randomized. Ten patients were
excluded, leaving 390 in the final modified

Among 390 analyzed patients (median age,


57 years; 187 [48%]women), the median
(IQR) hospital length of stay was 6 3-10)
days. Administration of aspirin, compared
with placebo, did not significantly reduce
the incidence of ARDS at 7 days (10.3%
vs 8.7%, respectively.No significant
differences were seen in secondary
outcomes: ventilator-free to day 28, mean
(SD), 24.9 (7.4) days vs 25.2 (7.0) days; ICU
length of stay, 5.2 (7.0) days vs 5.4 (7.0)
days , hospital length of stay, mean (SD),
8.8 (10.3) days vs 9.0 (9.9) days or 28-day
survival, 90% vs 90% or 1-year survival,
73% vs 75%, Bleeding-related adverse
events were infrequent in both groups
(aspirin vs placebo, 5.6% vs 2.6%);
Among 390 analyzed patients (median
age, 57 years; 187 [48%] women), median
(IQR) hospital length of stay was 6 (3-10)
days. Administration of aspirin, compared
with placebo, did not significantly
reduce the incidence of ARDS at 7 days.
No significant differences were seen in
secondary outcomes or adverse events.
Among at-risk patients presenting to the
ED, the use of aspirin compared with
placebo did not reduce the risk of ARDS at
7 days. The findings of this phase 2b trial
do not support continuation to a larger
phase 3 trial.

Effect of Conservative vs Conventional


Oxygen Therapy on Mortality Among
Patients in an Intensive Care Unit: The
Oxygen-ICU Randomized Clinical Trial.
Girardis M, Busani S, Damiani Eet al
JAMA. 2016 Oct 18;316(15):1583-1589
Despite suggestions of potential harm from
unnecessary oxygen therapy, critically
ill patients spend substantial periods in a
hyperoxemic state. A strategy of controlled
arterial oxygenation is thus rational but

Patients Oxygen-ICU was a single-center,


open-label, randomized clinical trial
conducted from March 2010 to October
2012 that included all adults admitted
with an expected length of stay of 72 hours
or longer to the medical-surgical ICU of
Modena University Hospital, Italy. The
originally planned sample size was 660
patients, but the study was stopped early
due to difficulties in enrollment after
inclusion of 480 patients.
Patientswere randomly assigned to
receive oxygen therapy to maintain Pao2
between 70 and 100 mm Hg or arterial
oxyhemoglobin saturation (Spo2) between
94% and 98% (conservative group) or,
according to standard ICU practice, to
allow Pao2 values up to 150 mm Hg
or Spo2 values between 97% and 100%
(conventional control group).
The primary outcome was ICU mortality.
Secondary outcomes included occurrence
of new organ failure and infection 48 hours
or more after ICU admission.
Results A total of 434 patients (median
age, 64 years; 188 [43.3%]women) received
conventional (n=218) or conservative
(n=216) oxygen therapy and were included
in the modified intent-to-treat analysis.
Daily time-weighted Pao2 averages
during the ICU stay were significantly
higher (P<.001) in the conventional group
(median Pao2, 102 mm Hg [interquartile
range, 88-116]) vs the conservative group
(median Pao2, 87 mm Hg [interquartile
range, 79-97]). Twenty-five patients in the
conservative oxygen therapy group (11.6%)
and 44 in the conventional oxygen therapy
group (20.2%) died during their ICU stay
(absolute risk reduction [ARR], 0.086 [95%
CI, 0.017-0.150]; relative risk [RR], 0.57
[95% CI, 0.37-0.90]; P=.01). Occurrences
were lower in the conservative oxygen
therapy group for new shock episode
(or liver failure and new bloodstream
infection
Among critically ill patients with an ICU
length of stay of 72 hours or longer, a
conservative protocol for oxygen therapy
vs conventional therapy resulted in lower
ICU mortality. These preliminary findings
were based on unplanned early termination
of the trial, and a larger multicenter trial is
needed to evaluate the potential benefit of
this approach.

Pulmonary Communications A quarterly Newsletter of National College of Chest Physicians

15

Published By :
National College of Chest Physicians (India)
For Free Circulation Amongst Medical Professionals
Vallabhbhai Patel Chest Institute, University of Delhi 110007.
Mobile : +91 9810033395 e-mail : drchawla@hotmail.com
Printed at : urvi compugraphics 022-2494 5863 email : urvi@urvi.cc

16

Editorial Office

Dr. Rajesh Chawla

Institute of Respiratory Medicine, Critical Care and Sleep Medicine,


Indraprastha Apollo Hospitals, Gate No.-2, 2nd Floor, Room No. 1223, Sarita Vihar,
Delhi-Mathura Road, New Delhi - 110076 Mobile : +91 9810033395

drchawla@hotmail.com

Pulmonary Communications A quarterly Newsletter of National College of Chest Physicians

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