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Research Papers

Identifying Critical Design Parameters for Improved Body Temperature Measurements: A Clinical Study Comparing Transient and Predicted Temperature Measurements

[+] Author and Article Information
Oleg Vesnovsky

FDA Center for Devices & Radiological Health,
Silver Spring, MD 20993
e-mail: oleg.vesnovsky@fda.hhs.gov

Liang Zhu, Alireza Chamani

Department of Mechanical Engineering,
University of Maryland,
Baltimore County,
Baltimore, MD 21250

Laurence W. Grossman, Jon P. Casamento

FDA Center for Devices & Radiological Health,
Silver Spring, MD 20993

Nadeesri Wijekoon

Department of Mathematics and Statistics,
University of Maryland,
Baltimore County,
Baltimore, MD 21250

L. D. Timmie Topoleski

FDA Center for Devices & Radiological Health,
Silver Spring, MD 20993;
Department of Mechanical Engineering,
University of Maryland,
Baltimore County,
Baltimore, MD 21250
e-mail: topoleski@umbc.edu

1O. Vesnovsky and L. Zhu both contributed equally.

2Corresponding authors.

Manuscript received May 16, 2017; final manuscript received September 24, 2018; published online December 4, 2018. Assoc. Editor: Xiaoming He. This work is in part a work of the U.S. Government. ASME disclaims all interest in the U.S. Government's contributions.

J. Med. Devices 13(1), 011005 (Dec 04, 2018) (15 pages) Paper No: MED-17-1225; doi: 10.1115/1.4041589 History: Received May 16, 2017; Revised September 24, 2018

Readily available store brand, or “home,” thermometers are used countless times in the home and clinic as a first diagnostic measure of body temperature. Measurement inaccuracies may lead to unnecessary medical visits or medication (false positives), or, potentially worse, lack of intervention when a person is truly sick (false negatives). A critical first step in the design process is to determine the shortcomings of the existing designs. For this project, we evaluated the accuracy of three currently available store brand thermometers in a pediatric population. The accuracies of the thermometers were assessed by comparing their body temperature predictions to those measured by a specially designed and calibrated and fast-responding reference thermometer. The reference thermometer was placed at the measurement site simultaneously with the store brand thermometer and recorded the temperature at the measurement site continuously. More than 300 healthy or sick pediatric subjects were enrolled in this study. Temperatures were measured at both the oral and axillary (under the arm) sites. The store brand thermometer measurements characteristically deviated from the reference thermometer temperature after 120 s, and the deviations did not follow a consistent pattern. The Brand C thermometers had the greatest deviations of up to 3.7 °F (2.1 °C), while the Brand A thermometers had the lowest deviations; however, they still deviated by up to 1.9 °F (1.1 °C). The data showed that the tested store brand thermometers had lower accuracy than the ±0.2 °F (0.1 °C) indicated in their Instructions for Use. Our recorded reference (transient) data showed that there was a wide variation in the transient temperature profiles. The store brand thermometers tested stated in their documentation that they are able to predict a body temperature based on transient temperature values over the first 5–10 s of measurements, implying that they use an embedded algorithm to extrapolate to the steady-state temperature. Significant deviations from the maximum temperature after time t = 4.6t0.63 illustrated that the transient temperature profiles may not be represented by an exponential function with a single time constant, t0.63. The accuracy of those embedded algorithms was not confirmed by our study, since the predicted body temperatures do not capture the large variations observed over the initial 10 s of the measurements. A thermometer with an error of several degrees Fahrenheit may result in a false positive or negative diagnosis of fever in children. The transient temperature measurements from our clinical study represent unique and critical data for helping to design the next generation of readily available, highly accurate, home thermometers.

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Figures

Grahic Jump Location
Fig. 1

Examples of temperature transient data recorded by the reference thermometer at the oral site in healthy patients in the 7–12 year old groups. The two data sets on each graph represent the transient behavior for the highest and lowest measured temperatures at 100 s. There was essentially a continuum of different transient responses and values of T at 100 s (shown in the Appendix). The vertical dashed line in each panel represents the average values of the 4.6t0.63. These curves represent the transient response upon which the store brand thermometers base their predictions. Graph (a) shows two similar transient curves rising in parallel. The curves start at different temperatures based on environmental and patient conditions. Graph (b) shows the transient behavior of the two curves crossing, where the lower final temperature curve actually started at a higher initial temperature.

Grahic Jump Location
Fig. 2

Time constant t0.63 at the axillary site in different age groups of healthy patients. Error bars represent standard deviation.

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Fig. 3

Average temperatures at various time instants measured by the reference thermometer and the predicted temperature by the store brand A thermometers. The data are presented for results from healthy patients in three age groups at the oral site. The average temperature measurements at 120 s were not statistically significantly different.

Grahic Jump Location
Fig. 4

Average temperatures at various time instants measured by the reference thermometer and the predicted temperature by the store Brand A thermometers. The data are presented for results from healthy patients in four age groups at the axillary site. The average temperature measurements at 120 s were not statistically significantly different.

Grahic Jump Location
Fig. 5

Average temperatures at various time instants measured by the reference thermometer and the predicted temperature by the store Brand A thermometers. The data are presented for results from sick patients in two age groups at the axillary (left graphs) and oral (right graphs) sites. The average temperature measurements at 120 s were not statistically significantly different.

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Fig. 6

An example of the ranges of temperature differences between the reference thermometer at two minutes and store brand thermometer (B) at the axillary sites for the healthy patients (a), and sick patients (b). Positive temperature differences mean that the temperature sensed by the store brand thermometer is larger than that by the reference thermometer. Complete data at both the axillary and oral sites are given in the Appendix.

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Fig. 7

Temperature difference data from each store brand thermometer (probe) showing the dispersion of temperature differences between the reference thermometer at two minutes and a store brand thermometer (B) at the axillary sites for the healthy (a) and sick (b) patients. Each individual thermometer (probe) is represented by a unique symbol. Note the inconsistency in individual thermometer results. Complete data at both the axillary and oral sites are given in Appendix.

Grahic Jump Location
Fig. 8

Examples of temperature transient data recorded by the reference thermometer in healthy patients in the 7–12 year old groups. These plots show essentially a continuum of different transient responses and values of T at 100 s. The vertical dashed line in each panel represents the average values of the 4.6t0.63. These curves represent the transient response upon which the store brand thermometers base their predictions.

Grahic Jump Location
Fig. 9

Average temperatures at 10, 60, and 120 s measured by the reference thermometer and temperature predicted by the store Brand B and C thermometers in the fast predictive mode. The data are presented for results from healthy patients in three age groups at the oral site (it was not possible to collect oral measurements in the 0–2 yr age group). The average temperature measurements at 120 s were not statistically significantly different.

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Fig. 10

Average temperatures at 10, 60, and 120 s measured by the reference thermometer and the predicted temperature by the store Brand B and C thermometers. The data are presented for results from healthy patients in four age groups at the axillary site. The average temperature measurements at 120 s were not statistically significantly different: (a) Brand B and (b) Brand C.

Grahic Jump Location
Fig. 11

Temperature differences between the reference thermometer at two minutes and the store brand thermometers at the oral site for the healthy and sick patients. Positive temperature differences mean that the temperature sensed by the store brand thermometer is larger than that by the reference thermometer: (a) Brand A, (b) Brand B, and (c) Brand C.

Grahic Jump Location
Fig. 12

Data from each store brand thermometer (probe) showing the temperature differences between the reference thermometer at two minutes and the store brand thermometers at the oral (healthy and sick) and axillary (sick) sites. Each individual thermometer (probe) is represented by a unique symbol. Note the inconsistency in individual thermometer results: (a) Brand A, (b) Brand B, and (c) Brand C.

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