Validity And Reliability Of The CortempTm Telemetric Pill During 50 H Of Reuse.

Abstract

Continuous measurement of rectal temperature using a telemetric pill (TP) inserted as a suppository has been validated. However, the use of TP may remain limited because of its high cost and single use. We have determined in our laboratory that the CorTempTM TP can be used repeatedly over time; in fact, it has a large battery autonomy, can be turned on and off at will and easily survives high-level disinfection. Reuse of the TP is made possible using a technique involving inserting the TP inside a condom, attaching it to a dental floss and introducing the TP inside the rectum with an over-the-counter suppository applicator. PURPOSE: The aim of the study was to examine the validity and reliability of CorTempTM TPs during repeated use in a water bath for a duration of 50 h. METHODS: Three TPs already used for less than 5 h each in a previous human study were tested in a water bath during 20 trials ranging from 1 to 5 h each, for a total of 50 h and with temperature variations ranging from 37 to 40°C. Trials were conducted in a randomized manner and temperatures of the TPs were compared to those of a wired rectal probe (YSI 401, WRP). After each trial, TPs were placed in a 2.5% glutaraldehyde solution for 20 min to achieve high-level disinfection, as recommended when a probe is used with a condom. The WRP and each TP were calibrated before the start of the experiment. Acceptable agreement between sensors was taken as a bias ≤ 0.2°C (sum of both instrument measurement errors). RESULTS: 50 h mean biases and random errors between TP 1, 2 and 3 and the WRP were of -0.09°C/±0.12°C, -0.10°C/±0.14°C and -0.12°C/±0.15°C, respectively. Mean biases and random errors at 17 h, 34 h and 50 h of reuse were of respectively -0.10°C/±0.11°C, -0.06°C/±0.11°C and -0.11°C/±0.11°C for TP 1 vs. WRP, -0.09°C/±0.13°C, -0.08°C/±0.12°C and -0.13°C/±0.16°C for TP 2 vs. WRP and -0.14°C/±0.17°C, -0.10°C/±0.13°C and -0.11°C/±0.12°C for TP 3 vs. WRP. CONCLUSION: Our results indicate that the CorTempTM TP can be reused up to at least 50 h while still providing valid and reliable temperature readings. Furthermore, the CorTempTM TP can undergo high-level disinfection repeatedly while maintaining full structural and functional integrity.