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

Sponsor

Rambam Health Care Campus (Other)

Overall Status

Unknown status

CT.gov ID

NCT01196663

Collaborator

(none)

500

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
to Evaluate the Performance of the TMS Thermometer and Improve Its Algorithm	Device: Intraoperative temperature measurement by TMS thermometer Device: Esophageal or urinary bladder temperature measurement	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Clinical Evaluation of TMS (Temperature Monitoring System) Performance

Study Start Date :

Apr 1, 2008

Anticipated Primary Completion Date :

Dec 1, 2008

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month and Older

Sexes Eligible for Study:

All

Accepts 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept of anesthesiology -Rambam health care campus	Haifa		Israel	31096

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

Principal Investigator: Avi Weissman, MD, Rambam Health Care Campus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01196663

Other Study ID Numbers:

TMS-thermometer-CTIL

First Posted:

Sep 8, 2010

Last Update Posted:

Sep 22, 2010

Last Verified:

Jul 1, 2010

Keywords provided by , ,

TMS

Study Results

No Results Posted as of Sep 22, 2010