Clinical Research Directory

A Prospective, Controlled, Single-Center Confirmatory Study to Evaluate the Accuracy and Safety of Core Temperature Measurement Using the XST600 Electronic Thermometer Compared to the 3M SpotOn Thermometer in Adult Patients

Sponsor: Yonsei University

Summary

The body temperature measured by the skin is easily affected by the measurement environment such as temperature or humidity, and in some cases, the difference from the central body temperature is particularly large. Therefore, there has been an attempt to develop a new method of measuring skin body temperature to predict the central body temperature by measuring body temperature in the skin. The purpose of this study is to evaluate the effectiveness and safety of the core temperature measured using this medical device by comparing the accuracy of the body temperature measured through the XST600 electronic thermometer applying the HF technology developed by Chois Technology with the body temperature measured by the Gold Standard 3M Bair Hugger Temperature Monitoring System Model 370. - Number of target subjects: 117 in total - Basis for calculation: This clinical trial is an corroborating clinical trial to confirm the clinical accuracy and effectiveness of the test equipment (XST600), so it is set based on the requirements of ISO 80601-2-56 (the "Medical Device Standard" 50. Electronic thermometer). 1. Total number of target subjects: 117 (105 + 10%) \* At least 105 participants are required in accordance with ISO 80601-2-56:2017, and 117 participants are targeted by applying the normal research dropout rate of 10%. \* If the research procedure is completed in 105 participants without dropping out, the study is terminated. ① Normal body temperature subject: 82 (73 participants + 10%): Those with a core temperature of 36.1℃ (10) or more and 38.0℃ or less when measured by RCT. \* If the research procedure is completed in 73 participants without dropping out, the study is terminated. ② Number of subjects with heating: 35 (32 participants + 10%): Subjects with a core temperature of 38.0℃ or higher when measured by RCT \* According to ISO 80601-2-56, the maximum number of subjects with heating is 32, by applying the standard that should not exceed 30%, and the target is 35, by applying the normal research dropout rate of 10%. \* If the research procedure is completed without dropping out of only 32 subjects, the study is terminated.

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