Comparison of the Performance of TMS-thermometer With Standard Esophageal or Urine Bladder Thermometer

Not Applicable

• Conditions: to Evaluate the Performance of the TMS Thermometer and; Improve Its Algorithm

• Registration Number: NCT01196663
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

This Clinical study is preformed in order to estimate the performance of the TMS thermometer and to make a final tuning of the thermometer mathematical algorithm.

Body temperature of men, women and children will be measured using the TMS thermometer.

Each Patient will be measured both with the TMS thermometer and with an esophageal or urinal thermometer as a reference.

Detailed Description

Temperature measurement is vital during surgery. Accurate temperature reading can indicate patient's condition and alarm if something is wrong.

Nowadays, during surgeries temperature is measured mostly using an esophageal or a urinal thermometer, both of which are invasive, therefore they complicate the procedure and require time and activity of the medical stuff.

The TMS thermometer combines a noninvasive, biocompatible patch, which is attached to the body, and a receiving unit, which is placed near the body or the vital signs monitors and receives data from the patch. There is no connection between the body and the receiving unit. The measurement is based on a conductive sensor that measures the skin temperature and applies special algorithm in order to calculate the core body temperature.

The purpose of this clinical study is to evaluate the performance of the TMS thermometer and improve its algorithm by comparing its measurement to the esophageal or urinal temperature measurement

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2008-12
• Status Verified: 2010-07
• Study First Submitted: 2010-07-28
• Study First Submitted QC: 2010-09-05
• Study First Posted: 2010-09-08
• Last Update Submitted: 2010-09-21
• Last Update Posted: 2010-09-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Men, women and children that are about to have surgery which requires temperature monitoring.
• An informed consent was signed by the patient or his guardian.

Exclusion Criteria

• The medical staff decides that the patient can't participate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Correlation between TMS and the esophageal/urinary temperature measurements	The results of this study will be presented in 6 months from today (an average)	TMS will track patient's temperature during the operation concurrently with esophageal and/or urinary temperature sensor. Correlation will be calculated between both temperature measurement methods and tracking ability of the changes in patient's temperature during the operation will be compared.

Trial Locations

Locations (1)

Dept of anesthesiology -Rambam health care campus; 🇮🇱 Haifa, Israel