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

Rambam Health Care Campus

Status

Unknown

Conditions

Improve Its Algorithm

to Evaluate the Performance of the TMS Thermometer and

Treatments

Device: Intraoperative temperature measurement by TMS thermometer

Device: Esophageal or urinary bladder temperature measurement

Study type

Interventional

Funder types

Other

Identifiers

NCT01196663

TMS-thermometer-CTIL

Details and patient eligibility

About

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.

Full 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

Enrollment

500 estimated patients

Sex

All

Ages

1+ month old

Volunteers

No Healthy Volunteers

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