The Usefulness of an Earphone-Type Infrared

Tympanic Thermometer for Intraoperative Core

Temperature Monitoring
Tomohiro Kiya, MD
Michiaki Yamakage, MD, PhD
Tomo Hayase, MD
Jun-Ichi Satoh, MD
Akiyoshi Namiki, MD, PhD
BACKGROUND: In this study we sought to determine the usefulness of a novel
earphone-type infrared tympanic thermometer (IRT) for core temperature moni-
toring during surgery.
METHODS: Two groups of patients were studied under different surgical conditions.
The first group consisted of 18 adult patients (ASA I or II) who had been scheduled for
elective surgery under general anesthesia. Before induction of general anesthesia, an
earphone-type IRT was inserted into either the left or right ear canal. Tympanic
temperature was monitored and recorded along with both rectal and esophageal
temperatures during anesthesia. The second group consisted of eight adult patients
(ASA II or III) who had been scheduled for cardiac surgery with cardiopulmonary
bypass. Similar to the first group, tympanic temperature was measured by the
earphone-type IRT and recorded along with the rectal and esophageal temperatures
during cooling and rewarming phases of cardiopulmonary bypass.
RESULTS: Study 1—The average temperature (⫾2 sd) measured with the IRT was
⫹0.08°C (⫾0.34°C) above the esophageal temperature, and that with the rectal
temperature was ⫹0.11°C (⫾0.55°C) above the esophageal temperature. Study
2—The average temperature (⫾2 sd) measured with the IRT was ⫹0.72°C (⫾2.2°C)
above the esophageal temperature during cooling and warming phases during
cardiac surgery with cardiopulmonary bypass.
CONCLUSIONS: The earphone-type IRT might be used in a clinical setting for reliable
and continuous core temperature monitoring during an operation.
(Anesth Analg 2007;105:1688 –92)

I t is important to measure and actively control body

temperature during surgery to avoid the complica-
tions of perioperative hypothermia (1– 4), such as
morbid cardiac events (5) and surgical wound infec-
tions (6). Core temperature during general anesthesia
is usually monitored in the esophagus, rectum, or
bladder. However, temperature measurement at these
locations is invasive and nonhygienic (7). Further-
more, rectal and bladder temperatures may not reflect
the values and changes of central body core tempera-
ture (8 –10). Particularly during lower abdominal sur-
gery, rectal and bladder temperatures exhibit much
From the Department of Anesthesiology, Sapporo Medical Uni-
versity, School of Medicine, Sapporo, Hokkaido, Japan.
Accepted for publication August 27, 2007.
Supported in part by a grant-in-aid (2005) for clinical research
from Sapporo Medical University for the Promotion of Science,
Sapporo, Japan.
This paper was presented in part at the annual meeting of the
American Society of Anesthesiologists, Chicago, IL, USA, October
14 –18, 2006.
Address correspondence and reprint requests to Michiaki Yamak-
age, MD, PhD, Department of Anesthesiology, Sapporo Medical Uni-
versity School of Medicine, South 1, West 16, Chuo-ku, Sapporo,
Hokkaido 060-8543, Japan. Address e-mail to yamakage@sapmed.
ac.jp.
Copyright © 2007 International Anesthesia Research Society
DOI: 10.1213/01.ane.0000289639.87836.79
lower values than esophageal or tympanic tempera-
tures because they are influenced by operating room
temperature and surgical procedures (11).
Because tympanic temperature directly reflects the
core temperature of the carotid artery (12), we have
developed an earphone-type infrared tympanic ther-
mometer (IRT) that can continuously measure the
temperature of the tympanic membrane (Fig. 1). In the
current study, we evaluated the usefulness of the IRT
for core temperature monitoring during operations
with and without cardiopulmonary bypass (CPB).
METHODS
This open single-center trial was approved by the
IRB of Sapporo Medical University Hospital (Sapporo,
Japan), and written informed consent was obtained
from each patient. The patients who had esophageal,
anal, and/or external auditory canal diseases were
excluded from the study.
Study 1: Nonabdominal and Noncardiac Surgery
Eighteen adult patients (ASA I or II, between 18 and
75 yr) who had been scheduled for elective nonab-
dominal and noncardiac surgery under general anes-
thesia were enrolled in this study. No premedication
was given. Before induction of anesthesia with the
patients in the supine position, the probe of the

1688 Vol. 105, No. 6, December 2007

Figure 1. Appearance of the originally de-
veloped earphone-type infrared tympanic
thermometer. An earphone-type probe of
the infrared tympanic thermometer (A) is
inserted into either the left or right ear canal
(B). The tip of the probe does not come into
direct contact with the tympanic membrane.
earphone-type IRT was inserted into either the left or
right ear canal to measure the temperature of the
tympanic membrane (TTym). General anesthesia was
induced using IV propofol (1.0 –1.5 mg/kg) and fen-
tanyl (1.0 –2.0 ␮g/kg), and intubation of the trachea
was performed with 0.15 mg/kg vecuronium. Anes-
thesia was maintained with 1.0%–2.0% sevoflurane in
oxygen with intermittent administration of fentanyl
(50 –100 ␮g) as an adjuvant analgesic. After induction of
general anesthesia, thermistor probes were inserted into
the rectum (approximately 8 cm) and esophagus (ap-
proximately 30 cm) for measurements of rectal (TRec) and
esophageal (TEso) temperatures, respectively, using a
thermometer (CTM-210TM; Terumo, Tokyo, Japan).
These measured temperatures were monitored and re-
corded automatically to a personal laptop computer at
1-min intervals. The temperatures of operating rooms
were kept at 22°C–24°C, and a forced-air warming
system (Bair HuggerTM; Arizant Healthcare, Eden Prai-
rie, MN) was used to warm the patient.
Study 2: Cardiac Surgery with CPB
Eight adult patients (ASA II or III, between 40 and
80 yr) who had been scheduled for elective cardiac
surgery with CPB were enrolled in this study. No
premedication was given. Similar to Study 1, the
probe of an earphone-type IRT was inserted into
either the left or right ear canal before induction of
anesthesia. General anesthesia was induced by IV
midazolam (0.05– 0.15 mg/kg) and fentanyl (5–10
␮g/kg), vecuronium (0.15 mg/kg) was given and
intubation of the trachea was performed. Anesthesia
was maintained with 1.0%–2.0% sevoflurane in oxy-
gen with intermittent administration of fentanyl
(50 –100 –200 ␮g) as an adjuvant analgesic. After in-
duction of general anesthesia, thermistor probes were
inserted into the rectum (approximately 8 cm) and
Vol. 105, No. 6, December 2007
esophagus (approximately 30 cm) for measurements
of TRes and TEso, respectively. These measured tem-
peratures were monitored and recorded at 1-min
intervals. The temperatures of operating rooms were
kept at 19°C–21°C, and a conductive warming/
cooling system (Medi-therm IIITM; Orchard Park, NY)
was used to control the patient’s body temperature.
Statistical Analysis
The TTym measured by the earphone-type IRT was
evaluated in comparison with TEso as a body core
temperature (7,13). Bland-Altman plots were used to
evaluate the limits of agreement between TTym and
TEso. The mean value of the difference (⫽bias) ⬎0.4°C,
and 2 sd (repeatability or precision) ⬎⫾1.0°C was
considered clinically significant (12).
RESULTS
We enrolled 18 patients (aged 18 to 67 yr [mean 46.2
yr]) in Study 1, and eight patients (aged 56 to 78 yr
[mean 68.3 yr]) in Study 2. The median durations of
the operations were 186 min (range, 50 – 650 min) in
Study 1, and 342 min (range, 250 – 654 min) in Study 2.
The measured ambient temperature ranged from
19.0°C to 24.2°C in both studies. After deletion of
obvious artifacts caused by bipolar high frequency
coagulation, we obtained 2610 measurements in Study
1 and 521 measurements in Study 2 with each of the
three devices. There were no complications related to
the site of insertion of the probe in the ear canal.
Study 1: Nonabdominal and Noncardiac Surgery
Figure 2 shows the Bland-Altman plot comparing
TTym and TEso, and TRec and TEso, in nonabdominal
and noncardiac surgery, respectively. The average
temperature measured with the IRT was ⫹0.08°C
above the TEso with ⫾0.34°C 2 sd, and that with the
© 2007 International Anesthesia Research Society 1689

TRec was ⫹0.11°C above the TEso with ⫾0.55°C 2 sd.
The bias and repeatability between TTym and TEso was
⬍0.1°C and ⬍0.5°C, respectively.
Study 2: Cardiac Surgery with CPB
The Bland-Altman plot of the temperature mea-
surements during cooling and rewarming phases with
CPB is shown in Figure 3. The average TTym was
⫹0.72°C above the TEso with ⫾2.2°C 2 sd, and that
with the TRec was ⫹0.43°C above the TEso with ⫾3.4°C
2 sd.
DISCUSSION
Measurement of TRec or bladder temperature is
widely used for monitoring body core temperature
during surgery. Although measurements of those tem-
peratures have been reported to be reliable for core
temperature monitoring (14), it is difficult to follow
sudden core temperature changes by such measure-
ments (15) and, therefore, these measurements are not
reliable in the case of malignant hyperthermia or
sudden decline in body temperature. Rectal or bladder
measurements are even less reliable during lower
abdominal surgery because they are influenced by
operating room temperature (11). Moreover, although
1690 Infrared Tympanic Thermometer
Figure 2. Bland-Altman analysis be-
tween tympanic (TTym) and esopha-
geal temperatures (TEso) (A) and be-
tween rectal (TRec) and esophageal
temperatures (TEso) (B) in nonabdomi-
nal and noncardiac surgery. The aver-
age temperature measured with the
infrared infrared tympanic thermom-
eter (IRT) was ⫹ 0.08°C above the TEso
with ⫾ 0.34°C 2 sd, and that with the
TRec was ⫹ 0.11°C above the TEso
with ⫾ 0.55°C 2 sd. The bias and
repeatability between TTym and TEso
was ⬍0.1°C and ⬍0.5°C, respectively.
Figure 3. Bland-Altman analysis between
tympanic (TTym) and esophageal tem-
peratures (TEso) (A) and between rectal
(TRec) and esophageal temperatures
(TEso) (B) in cardiac surgery with cardio-
pulmonary bypass. The average TTym
was ⫹ 0.72°C above the TEso with ⫾
2.2°C 2 sd, and that with the TRec was ⫹
0.43°C above the TEso with ⫾ 3.4°C 2 sd.
the probe for TRec monitoring is equipped with a
disposable cover, there are problems regarding hy-
giene and obtaining informed consent for use from the
patient. Measurement of bladder temperature is a
convenient method for surgery in which a urethral
catheter is used, but this method cannot be used for a
short operation or during sedation, in which a bladder
catheter is not needed.
TEso measurement and contact-type TTym measure-
ment have high degrees of reliability for monitoring
core temperature (7,13). However, because of its inva-
sive nature, TEso measurement for core temperature
monitoring can only be used for operations under
general anesthesia, and the probe is difficult to insert
in patients undergoing regional anesthesia (16) and
general anesthesia via a laryngeal mask airway. Inser-
tion of the probe may also cause damage to the
pharynx or esophagus. Measurement of TTym has been
established as a useful method for core temperature
monitoring because the blood to the tympanic mem-
brane is supplied directly by the carotid artery (7,13).
However, a contact-type TTym monitoring device can
cause pain in the tympanic membrane when inserted
in an awake state, and there have been reports of
tympanic membrane damage caused by insertion of
ANESTHESIA & ANALGESIA
the device during unconsciousness (17,18). Several
infrared noncontact-type tympanic thermometers
have been developed (12,19,20). However, these de-
vices cannot be used for continuous temperature
monitoring, and there is a problem in discrepancy of
measured values (19,20).
To resolve these problems, we have developed an
earphone-type iIRT-monitoring device, which is a
noncontact-type device that enables continuous tem-
perature monitoring. This newly developed device
has two notable features. First, we succeeded in manu-
facturing a prototype earphone-type temperature sen-
sor with a miniaturized infrared ray measurement
component (Fig. 1). Moreover, by using an appropri-
ate algorithm, we succeeded in continuous measure-
ment of infrared rays from the tympanic membrane at
1-s intervals with no drift in measured values (⫾
0.1°C, 32°C–34°C). The results of Bland-Altman anal-
ysis in this study showed very small bias (systemic
error) ⬍0.1°C and the repeatability (precision) ⬍0.5°C
between TTym and TEso, meaning that the temperature
measurements by using this device are reliable for
core temperature monitoring. The average TTym was
rather high (⫹0.72°C) above the TEso during cardiac
surgery with CPB. Furthermore, the bias and repeat-
ability seems to be larger than those reported by Bock
et al. (12) This might have been for the following two
reasons: 1) number of data from the cooling phase was
more than that from the warming phase, resulting in
increase of bias, and 2) this device can measure the
external ear canal not the direct tympanic membrane
in some patients.
Because the device is noninvasive, it can also be
used for sedation (21) and regional anesthesia (16),
and the probe of the thermometer can be inserted by
patients themselves. Another advantage of this ther-
mometer is that it is hygienic because it does not come
into contact with the patient’s infectious body fluids.
A disposable cover is therefore not needed for the
device, and the device can be used repeatedly, after
only wiping the sensor part with an ethanol cotton
swab until sensor membrane damage occurs.
Future issues regarding the newly developed ther-
mometer include generally applicability and problems
with measured values just after insertion. First, there
is a problem in the material used in the device.
Because of the differences in ear canal shape, further
consideration must be given to the material used in
the device for general applicability. The use of a
material with a high degree of plasticity, such as
urethane or silicone, or the manufacture of devices
with various sizes is expected. There is also a problem
in measurement just after insertion of the probe. It
took a few minutes (2 to 3 min) after probe insertion to
obtain constant values in some of the patients in this
study. This may have been because of the influence of
the tympanic membrane on the closed external audi-
tory canal, which is where the sensor part of the device
is located. However, TTym obtained by using the
Vol. 105, No. 6, December 2007
device showed a good correlation with measurements
of TEso even in these patients after the measured TTym
had become constant. Consideration will be given to
modification of the device to resolve this problem. The
device also needs to be evaluated in febrile patients.
In summary, Bland-Altman analysis of temperature
data obtained from patients during general anesthesia
revealed that temperature measurements obtained by
using an earphone-type IRT could be reliable for core
temperature monitoring. Tympanic temperature could
follow changes in core temperature well, because rather
small standard deviation between TTym and TEso were
obtained in the cooling and rewarming phases of cardiac
surgery with CPB. Infrared TTym membrane measure-
ment is noninvasive and hygienic and, based upon the
patients we studied, is suitable for continuous measure-
ment during anesthesia care.
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