NCT01196663

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

Clinical Evaluation of TMS (Temperature Monitoring System) Performance

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: All
• Age: 1 Month
• Healthy volunteers: Not accepted

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

Conditions

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

Interventions

Type	Name	Description
DEVICE	Intraoperative temperature measurement by TMS thermometer	Measurements will be taken from the patient's body using a biocompatible patch that will transfer data to the receiving unit. The patch will be sterilized before each surgery.
DEVICE	Esophageal or urinary bladder temperature measurement	Standard temperature measurement as is being measured from patients during surgery today

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-12-01
• First posted: 2010-09-08
• Last updated: 2010-09-22

Locations

1 site across 1 country: Israel