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Accuracy of a Noninvasive Temporal Artery Thermometer for Use in Infants
David S. Greenes, MD;
Gary R. Fleisher, MD
Arch Pediatr Adolesc Med. 2001;155:376-381.
ABSTRACT
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Objectives To assess the accuracy of a new noninvasive temporal artery (TA) thermometer
in infants; to compare the accuracy of the TA thermometer with that of a tympanic
thermometer, using rectal thermometry as the criterion standard; and to compare
the tolerability of the TA thermometer with that of the tympanic and rectal
thermometers.
Design Prospective evaluation of the accuracy of TA and tympanic thermometry,
using rectal thermometry as the criterion standard.
Setting Emergency department of an urban pediatric hospital.
Subjects Convenience sample of 304 infants younger than 1 year presenting for
care.
Main Outcome Measures Temperatures were measured using TA, tympanic, and rectal thermometers
for all infants. Agreement between TA or tympanic and rectal temperatures
was assessed. The sensitivity and specificity of TA or tympanic thermometers
for detecting rectal fever were determined. Discomfort scores, using a standardized
scale, were assessed by trained observers after each temperature measurement
was made.
Results Linear regression analysis of the relation between TA and rectal temperatures
yielded a model with a slope of 0.79 (vs a slope of 0.68 for tympanic vs rectal
temperature; P = .02) and an r of 0.83 (vs r = 0.75 for tympanic vs rectal
temperature; P<.001). Among 109 patients with
a rectal temperature of 38°C or higher, the TA thermometer had a sensitivity
of 0.66 compared with the tympanic thermometer's sensitivity of 0.49 (P<.001). Discomfort scores with TA thermometry were
significantly lower than with rectal thermometry (P
= .007).
Conclusions The TA thermometer has limited sensitivity for detecting cases of rectal
fever in infants. However, the TA thermometer is more accurate than the tympanic
thermometer in infants, and it is better tolerated by infants than rectal
thermometry.
INTRODUCTION
RECTAL THERMOMETRY has generally been considered the standard for measurement
of temperature in infants. Published guidelines for the management of febrile
infants have based their recommendations on measurement of rectal temperature,1 and other thermometry methods have generally been
evaluated with rectal temperature as the criterion standard.2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19
Although rectal thermometry has evolved as the standard, it has several
disadvantages, including discomfort for the patient, emotional upset for the
patient and parent,20, 21, 22
risk for traumatic injury to the rectum,23, 24, 25, 26, 27, 28, 29, 30
and transmission of stool-borne pathogens.31, 32, 33
Several alternative methods of thermometry, which eliminate the problems inherent
in rectal thermometry, have been shown to have limited value in other regards.
Axillary2, 11, 12, 18, 34, 35
and supralingual3, 4, 13
thermometers have generally proven too inaccurate for routine clinical use.
Tympanic thermometers, although popular with patients and parents and fairly
reliable in adults,22 have not proven adequate
for infants and young children.6, 10, 12, 14, 19, 36, 37, 38
Thus, a continued need exists for a form of thermometry that is as well tolerated
as the tympanic technique but gives results that closely agree with rectal
temperature.
The purpose of this study was to evaluate the performance of a new noninvasive
temporal artery (TA) thermometer for clinical use in infants. Our objectives
were (1) to evaluate the accuracy of the TA thermometer, using rectal temperature
as the criterion standard; (2) to compare the accuracy of the TA thermometer
with that of a tympanic thermometer; and (3) to compare patients' discomfort
with the use of the TA thermometer with their discomfort with tympanic and
rectal thermometry.
PATIENTS AND METHODS
PATIENT SELECTION
We performed a prospective study of a convenience sample of infants
presenting to the triage area of an emergency department in a tertiary care
pediatric hospital. Children were eligible for inclusion in the study if they
were younger than 1 year. Children were excluded if they had any medical condition
that contraindicated the use of a rectal, tympanic, or TA thermometer. Children
were also excluded if they were too ill to remain at triage for an initial
assessment before proceeding to a treatment room.
Patients were enrolled during shifts when trained research assistants
were available. During these shifts, the research assistants attempted to
enroll all eligible patients.
Our study was approved by the Committee on Clinical Investigation of
Children's Hospital, Boston, Mass. The committee required that verbal consent
be obtained from the parents of study subjects.
THERMOMETRY MEASUREMENTS
On arrival to the triage area of the emergency department, patients
and their families were invited to participate in the study. After oral consent
was obtained, 4 successive temperature measurements were made, including a
rectal temperature, a tympanic temperature, and left- and right-sided TA temperatures.
Rectal temperatures were measured using the Diatek electronic thermometer
(Welch Allyn Inc, Skaneateles Falls, NY). Tympanic temperatures were measured
using the First Temp Genius tympanic thermometer (Sherwood Medical, St Louis,
Mo). Both thermometers are used for routine clinical care in our hospital
and were maintained by the hospital's medical engineering department. Left-
and right-sided TA temperatures were measured using the Exergen TempScan Temporal
Artery Thermometer (model LXTA) (Exergen Corp, Watertown, Mass).
The TA thermometer is a handheld device that is operated by placing
its probe on the patient's forehead and then sweeping it laterally until the
hairline of the temporal scalp is reached. The device continually measures
surface temperature as it moves along its path and assumes the highest temperature
recorded to be the TA temperature. Using a simultaneous measure of ambient
temperature from a separate thermistor, the device calculates the patient's
core temperature and instantaneously reports this calculated temperature.
All temperatures were measured by trained research assistants. These
assistants were trained by the nursing staff of our emergency department to
use the rectal and tympanic thermometers, and they were certified by the nursing
department so that their measurements could be used in the clinical care of
patients. Representatives from Exergen trained the assistants in the use of
the TA thermometer. During a pilot phase, the assistants had several days
of practice sessions, in which their thermometry technique and results were
reviewed by the authors and representatives from Exergen, before data collection
began.
Research assistants were instructed to make each measurement only once.
Only when there were obvious mechanical failures (eg, the patients pulled
their heads away during the process) were the research assistants allowed
to repeat measurements with any of the thermometers. Research assistants were
told not to consider the measured temperature reading in determining whether
a measurement needed to be repeated. Conditions that appeared to the research
assistants to make a measurement unreliable (eg, patient's forehead buried
in parent's chest, making TA temperature potentially unreliable) were recorded.
DISCOMFORT ASSESSMENTS
To assess the experience of children with thermometry, a semiquantitative
discomfort scale was used. The scale, adapted from the work by Shane et al,39 is shown in Table
1. Research assistants were asked to assess behavior of the patients
and to assign a discomfort score immediately after measuring the rectal, tympanic,
and left-sided TA temperatures.
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Table 1. Infant Discomfort Scale*
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To ensure that the behavioral responses recorded after the use of a
given thermometer would not be influenced substantially by the preceding measurements,
the order of routes was varied from patient to patient. The right-sided TA
temperature was always the fourth measurement made. The order of the other
3 measurements was dictated by a preprinted data collection form. The data
collection form for each patient was taken blindly from the top of a shuffled
stack of data forms after the patient consented to enrollment.
DATA ANALYSIS
Reproducibility of TA temperature was assessed by performing a paired
sample t test and calculating a correlation coefficient
for the relation between left- and right-sided TA temperatures. For the purpose
of this analysis, cases in which 1 of the 2 TA measurements was noted to be
unreliable were excluded.
To evaluate the accuracy of TA and tympanic thermometry, rectal temperature
was considered the criterion standard. Both TA temperature and tympanic temperature
were assessed for their ability to predict rectal temperature. In doing this
analysis, left-sided TA temperature was used as the representative TA temperature.
In cases in which the left-sided TA temperature was noted to be unreliable,
right-sided temperatures were used.
Linear regression analysis was performed and correlation coefficients
were calculated for the relation between TA and rectal temperature and for
the relation between tympanic and rectal temperature. In addition, t tests were performed to compare the slopes of each of the 2 lines
generated by the linear regression models to a value of 1 to determine whether
TA or tympanic temperature readings were equivalent to rectal temperatures.
The slopes of the 2 lines generated were compared with one another using a t test as well. Correlation coefficients were compared
using the Fischer z transform technique.
Patients with a rectal temperature of 38°C or higher were considered
to have rectal fever, and those with a rectal temperature of 39°C or higher
were considered to have high rectal fever. The sensitivity and specificity
of tympanic and TA thermometers for detecting temperatures of 38°C or
higher in cases of rectal fever were calculated. The sensitivities of tympanic
and TA thermometers for detecting temperatures of 38°C or higher in cases
of high rectal fever were calculated separately. Sensitivities and specificities
of the 2 thermometry methods were compared with one another using the McNemar
test. When comparisons showed no significant differences between the 2 thermometry
methods, post hoc power calculations were performed.
Discomfort scores for each of the 3 methods were compared with one another
using the Wilcoxon signed rank test. Because multiple (3) comparisons were
done in assessing discomfort scores, a Bonferroni correction was used, with P .017 considered significant for this analysis.
Statistical analysis was performed using the Statistical Program for
the Social Sciences, version 6.0 for Windows (SPSS Inc, Chicago, Ill), and
the Stata statistical package for Windows (Stata Inc, College Station, Tex).
RESULTS
During the 3-month study period, 304 patients were enrolled, of whom
109 (36%) had rectal fever and 49 (16%) had high rectal fever. Rectal temperature
was 37.9°C ± 1.0°C (mean ± SD), with a range of 35.7°C
to 40.7°C. Temporal artery temperature was 37.6°C ± 0.9°C,
with a range of 35.9°C to 40.7°C. Tympanic temperature was 37.1°C
± 0.9°C, with a range of 35.0°C to 39.9°C.
AGREEMENT BETWEEN LEFT- AND RIGHT-SIDED TA TEMPERATURES
For the purpose of this subanalysis, 44 patients were excluded because
the research assistants noted that either the left- or right-sided TA temperature
measurements were potentially unreliable. Among the remaining 260 patients,
the mean ± SD left-right difference was 0°C ± 0.39°C,
with a range of –1.3°C to 1.0°C. The r
between left- and right-sided TA temperatures was 0.91. A paired sample t test found no significant difference between left- and
right-sided TA temperatures (P = .59).
AGREEMENT BETWEEN TA OR TYMPANIC AND RECTAL TEMPERATURES
For all remaining analyses, all 304 patients were included. Linear regression
analysis of the relation between TA temperature and rectal temperature (Figure 1) yielded a model with a slope of
0.79 and an r of 0.83. Linear regression analysis
of the relation between tympanic temperature and rectal temperature (Figure 2) yielded a model with a slope of
0.68 and an r of 0.75. Both slopes were significantly
different from 1 (P<.001), indicating that neither
tympanic nor TA temperature was equivalent to rectal temperature.
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Figure 1. Scatterplot of rectal vs temporal
artery (TA) temperatures.
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Figure 2. Scatterplot of rectal vs tympanic
temperatures.
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The slopes generated for the 2 curves differed significantly from one
another (P = .02), indicating that TA temperature
was significantly closer to equivalence with rectal temperature than was tympanic
temperature. Comparison of the correlation coefficients from the 2 models
using the Fischer z transform showed significantly
closer correlation between TA and rectal temperature than between tympanic
and rectal temperature (P = .006).
SENSITIVITY AND SPECIFICITY
The sensitivities of the TA and tympanic thermometers for detecting
fever in patients with rectal fever (temperature  38°C) or high rectal
fever (temperature 39°C) are shown in Table 2. Using the McNemar test, we found the TA thermometer to
be significantly more sensitive than the tympanic thermometer for detecting
rectal fever (P<.001) and high rectal fever (P = .004).
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Table 2. Sensitivity and Specificity of Temporal Artery and Tympanic
Thermometers*
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The specificities of the TA and tympanic thermometers in patients with
no rectal fever are shown in Table 2.
Using the McNemar test, we found no significant difference between the specificity
of the tympanic and TA thermometers (P = .07). A
post hoc power calculation indicated that our study had a power of 0.35 for
detecting a statistically significant difference between 2 thermometry methods
with the measured specificities.
DISCOMFORT SCORES
The median discomfort score for the rectal thermometer was 3, with a
range of 1 to 5. For both the tympanic and TA thermometers, the median discomfort
score was 2, with a range of 1 to 5. The tympanic thermometer was associated
with significantly lower discomfort scores than the rectal thermometer (P<.001). The TA thermometer was also associated with
significantly lower discomfort scores than the rectal thermometer (P = .007).
COMMENT
We have found the TA thermometer to be significantly more accurate than
the tympanic thermometer for predicting rectal temperature in infants. The
TA thermometer is significantly more sensitive than the tympanic thermometer
for the detection of rectal fever in infants. In addition, the TA thermometer
is better tolerated by patients than the rectal thermometer.
Previous investigations have also suggested that tympanic thermometry
is a poor predictor of rectal temperature in infants. Brennan et al6 found that tympanic thermometry had a sensitivity
of only 0.76 for detecting rectal fever in children 6 months to 6 years of
age. Hooker10 reported that tympanic thermometers
had a sensitivity of 0.67 for detecting rectal fever in patients younger than
6 years. Muma et al12 reported that tympanic
thermometers had a sensitivity of 0.55 for detecting fever in 87 children
younger than 3 years.
Our data suggest that TA thermometry is a better choice than tympanic
thermometry for use in infants. However, TA thermometry does not reliably
predict rectal temperature in all clinical situations. Thirty-five percent
of all cases of rectal fever and 6% of cases of high-grade rectal fever were
missed by the TA thermometer.
One limitation of our study is that we do not have a true measure of
core body temperature to use as a criterion standard. In the literature, esophageal
or pulmonary artery (PA) temperatures are generally considered to be true
measures of core body temperature.40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54
Several published investigations have evaluated the accuracy of rectal thermometry
as an indicator of core body temperature compared with these invasive methods.
Some early studies55, 56 of the
physiology of human body temperature suggested a lag between instantaneous
changes in core body temperature and more delayed changes in rectal temperature.
It is possible, therefore, that in cases with large discrepancies between
TA and rectal measurements, the TA thermometer may be correctly reflecting
a rapid change in core body temperature, whereas the rectal temperature is
lagging behind. For instance, if antipyretics had been given several minutes
before the temperatures were measured, the TA temperature might accurately
reflect a lowered core body temperature, while the rectal temperature still
reflects the preceding fever. Future studies evaluating the changes in TA
and rectal temperatures in response to changes in core body temperature would
be of interest.
Although we must acknowledge this theoretical limitation, the bulk of
the published literature suggests that rectal thermometry is the best available
noninvasive indicator of core body temperature. In a study of 16 adults admitted
to an intensive care unit (ICU), Stavem et al43
reported better agreement between rectal and PA temperatures than between
tympanic and PA temperatures. Similarly, Schmitz et al47
reported that rectal temperatures were a better predictor of PA temperatures
than were oral, tympanic, or axillary temperatures in 13 adult patients in
an ICU. In a study of 20 patients in a pediatric ICU, Romano et al52 found that rectal thermometry had less bias and variability
than tympanic or axillary thermometers in predicting PA temperature. In a
study of 9 adult patients in an ICU, Milewski et al54
found a better correlation between rectal and PA temperature than between
tympanic and PA temperature. Only Rotello et al,46
in a study of 20 adult patients in an ICU, found a closer agreement between
tympanic temperature and PA temperature than between rectal and PA temperatures.
Even in this study, however, there was less variability in the difference
between rectal and PA temperatures than in the difference between tympanic
and PA temperatures.46 Given these reports,
we believe that rectal thermometry is an appropriate criterion standard for
noninvasive clinical thermometry.
Another limitation of our study is that we included only infants in
our sample. Given that the tympanic thermometer has been shown to be especially
unreliable in young infants, we caution the reader against extrapolating our
findings to older children or adults. Future studies comparing the TA thermometer
to the tympanic thermometer in older children or adults would be of interest.
We conclude that the TA thermometer has limited sensitivity for detecting
cases of rectal fever in infants. However, the TA thermometer is more accurate
than the tympanic thermometer in infants, and it is better tolerated by infants
than rectal thermometry. Rectal thermometry should still be considered the
preferred method for temperature measurement in infants. For clinicians who
choose not to use rectal thermometry for infants, the TA thermometer appears
to be a better alternative than the tympanic thermometer.
AUTHOR INFORMATION
Accepted for publication October 23, 2000.
This study was funded by a grant from the Exergen Corporation.
Presented as an abstract at the annual meeting of the Pediatric Academic
Societies, Boston, Mass, May 14, 2000.
We thank James DiCanzio for his statistical consultation. We thank Kelly
Johnston, BA, John Branda, MD, Jeanne Smith, MS, and Joyce Lee, MD, for their
help with patient enrollment and data collection.
From the Division of Emergency Medicine, Children's Hospital, Harvard
Medical School, Boston, Mass.
Corresponding author and reprints: David S. Greenes, MD, Division
of Emergency Medicine, Children's Hospital, 300 Longwood Ave, Boston, MA 02115
(e-mail: david.greenes{at}tch.harvard.edu).
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