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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Rambam Health Care Campus.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01196663
First received: July 28, 2010
Last updated: September 21, 2010
Last verified: July 2010
History of Changes
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of TMS (Temperature Monitoring System) Performance

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Correlation between TMS and the esophageal/urinary temperature measurements [ Time Frame: The results of this study will be presented in 6 months from today (an average) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 500
Study Start Date: April 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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

  Eligibility

Ages Eligible for Study:   1 Month and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01196663

Contacts
Contact: Avi Weissman, MD 972 4 854-2487 a_weissman@rambam.health.gov.il
Contact: Amit Lehavi, MD 972 4 854-2487 a_lehavi@rambam.health.gov.il

Locations
Israel
Dept of anesthesiology -Rambam health care campus Recruiting
Haifa, Israel, 31096
Contact: Avi Weissman, MD     972 4 854-2487     a_weissman@rambam.health.gov.il    
Principal Investigator: Avi Weissman, MD            
Sub-Investigator: Amit Lehavi, MD            
Sub-Investigator: Dror Segal, MD            
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Avi Weissman, MD Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Avi Weissman MD, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01196663     History of Changes
Other Study ID Numbers: TMS-thermometer-CTIL
Study First Received: July 28, 2010
Last Updated: September 21, 2010
Health Authority: Israel: Ethics Commission

Keywords provided by Rambam Health Care Campus:
TMS

ClinicalTrials.gov processed this record on May 23, 2013