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

September 21, 2010 updated by: Rambam Health Care Campus

Clinical Evaluation of TMS (Temperature Monitoring System) Performance

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Haifa, Israel, 31096
        • Recruiting
        • Dept of anesthesiology -Rambam health care campus
        • Contact:
        • Principal Investigator:
          • Avi Weissman, MD
        • Sub-Investigator:
          • Amit Lehavi, MD
        • Sub-Investigator:
          • Dror Segal, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

July 28, 2010

First Submitted That Met QC Criteria

September 5, 2010

First Posted (Estimate)

September 8, 2010

Study Record Updates

Last Update Posted (Estimate)

September 22, 2010

Last Update Submitted That Met QC Criteria

September 21, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TMS-thermometer-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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