Temperature Clinical Trial
Official title:
Accuracy and Precision Test of TempTraq® Compared to Pulmonary Artery Catheter for Monitoring Temperature in Adults in Intensive Care Unit
Purpose The purpose of this feasibility study is to assess the accuracy and precision of the
Temp-Traq thermometer for monitoring body temperature in adult patients under three
conditions (hypothermia, normothermia, and hyperthermia).
Specific Aims
1. To assess the accuracy of the Temp-Traq thermometer as compared to a gold standard (Core
temp measured by Pulmonary Artery Catheter)
2. To assess the precision of the Temp-Traq thermometer over repeated measures
3. To determine if accuracy &/or precision is consistent in three conditions (hypothermia,
normothermia, or hyperthermia)
Design A repeated measures within-group comparative design will be used for this study.
Sample/Setting To address the specific aims of this study the investigators will identify
patients (N = 40) who have a pulmonary artery (PA) catheter in place (patients in intensive
care units). Letters of support are attached from the unit managers where the study will take
place (see attached).
Procedure Once a patient is identified, the researcher will record basic demographic data
(see data collection form attached) and the axillary area will be assessed for visible signs
of any skin conditions. If there are no visible signs of a skin condition the researcher will
apply the Temp-Traq thermometer to the right or left axilla of the subject and record the
location of the placement. The researcher will record both the PA and Temp-Traq recordings of
subject's temperature (taken at the same time) on the data collection form (see attachment)
at four data points; baseline (5 minutes post application of Temp-Traq) and every two hours
(+/- 15 minutes) after baseline X 3. Previous testing of the TempTraq® on children and
healthy adults has not resulted in any adverse skin reactions. However, as this is a new
thermometer format and there is not a significant body of literature on potential skin
reactions, the investigators will assess skin before and after application. Thus, at the end
of the last reading the Temp-Traq thermometer will be removed and the skin will be assessed
for erythema. If erythema is present the patient's nurse and physician will be notified by
the researcher.
Protection of Human Subjects Since non-invasive temperature monitoring poses no risk to
patients and is part of usual care and since the investigators will not collect or record any
protected health information (PHI), written informed consent will not be sought. Patients
will be identified by their study ID number only. The data will be collected by a registered
nurse data collector familiar with the intensive care setting and data will be stored in a
locked file cabinet in the researchers locked office. Temperature data for the Temp-Traq is
collected through the Temp-Traq Application (AP) which will be placed on a Cleveland Clinic
Approved and encrypted i-pad. Once the study is completed and all data has been transferred
to the study database, the Temp-Traq application and all of its data will be deleted from the
i-pad.
Analysis The investigators will use the TOST (Two One Sided t-tests) method for equivalence
testing. This method requires a defined range of mean differences between two test methods,
an estimate of the precision of the measurement of the two systems, and an estimate of the
size of the possible difference in the means of the two methods under consideration. The TOST
null hypothesis is a joint null hypothesis that the mean measurement differences between the
two methods is greater than a critical lower bound and less than a critical upper bound. If
the null is rejected then the investigators can conclude that the absolute difference of the
means for the two groups falls within the specified range. It was determined that to be
considered equivalent with respect to accuracy the mean measurements of the two methods
should be within ± 0.2 degrees of each other. Precision tests for Temp-Traq thermometer using
accepted ASTM test methods for various combinations of temperature and humidity provided a
range of measurement variation between .0000435 and .019928 with a mean of 0.000254500. If
the investigators assume both test methods exhibit the same levels of precision then the
variance of the differences between their two means will reduce to two times the values
listed previously. This will result in estimates of the standard deviations of the mean
differences of .0093, .032, and .063 respectively.
The two methods for body temperature that will be examined are core temperature measurements
with a PA catheter and temperature measurements using the Temp-Traq (measured in Celsius).
Paired temperature measurements for both methods will be taken simultaneously every 2 hours
for a 6 hour period. This will provide 4 repeated temperature measures per patient. The
simultaneous measurements within a given patient should exhibit a high degree of correlation.
If .7 is chosen as the lower bound for the correlation between the paired readings (higher
correlations would result in an estimate of fewer patient samples thus the choice of .7 is
conservative) and if the average standard deviation of the mean of the differences is used as
an estimate of the expected variability, then it would be possible to declare measurement
equivalence for a difference of ±.19 with a sample size of 40 patients. This assumes the ASTM
measurements of instrument variation are representative of the within patient variance. Given
the vagaries of patient-to-patient this may be too optimistic an estimate.
A sample size of 40 patients will provide 80% or greater power for testing for equivalence
between methods where the mean difference is .1 or less for up to a ten-fold increase in the
estimates of the variability of the differences based on the ASTM precision measures and for
a mean difference of .15 for up to a five-fold increase in these same measures. If the sample
size is 40 then the power for the test of equivalence, where the difference is .15 and the
standard deviation is a ten-fold increase, is 35%. Agreement testing: The Bland-Altman test
will be used to test the agreement of the two methods. This test will permit a check for
significance of bias between the two measures (the average difference between the two
measures) as well as a check for significant trending over the range of the measurements. If
the bias is significant then the results of the two differ by an overall offset in their
measurements. If the trending (slope of the regression line) is significant then the
difference between the two measurements changes as their magnitude changes which means the
two methods are not in agreement.
The only measurements of instrument precision are those provided by the ASTM assessment. It
is reasonable to assume the within patient measurement variation will be greater than the
measurements from the controlled testing. A sample size of 40 patients is, from a statistical
standpoint, a reasonable number and this sample size provides acceptable power for a mean
difference of .1 for a ten-fold increase in the estimate of minimum test variability. This
sample size will also provide enough data for the Bland-Altman test for agreement. Because
this is a repeated measures test and even one missing measurement will impact the results,
the investigators plan to over-sample in order to assure the study has the power to answer
the questions posed.
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