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

Improve Its Algorithm Clinical Trial

Official title:

Clinical Evaluation of TMS (Temperature Monitoring System) Performance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01196663
• Other study ID #: TMS-thermometer-CTIL
• Status: Recruiting
• Phase: N/A
• First received: July 28, 2010
• Last updated: September 21, 2010
• Start date: April 2008

Study information

• Verified date: July 2010
• Source: Rambam Health Care Campus
• Contact: Avi Weissman, MD
• Phone: 972 4 854-2487
• Email: a_weissman[@]rambam.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

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

Intervention

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.
• Esophageal or urinary bladder temperature measurement
Standard temperature measurement as is being measured from patients during surgery today

Locations

Country	Name	City	State
Israel	Dept of anesthesiology -Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between TMS and the esophageal/urinary temperature measurements	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.	The results of this study will be presented in 6 months from today (an average)	No