Comparison of the Performance of TMS-thermometer With Standard Esophageal or Urine Bladder Thermometer
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|ClinicalTrials.gov Identifier: NCT01196663|
Recruitment Status : Unknown
Verified July 2010 by Rambam Health Care Campus.
Recruitment status was: Recruiting
First Posted : September 8, 2010
Last Update Posted : September 22, 2010
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||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Evaluation of TMS (Temperature Monitoring System) Performance|
|Study Start Date :||April 2008|
|Estimated Primary Completion Date :||December 2008|
Device: Intraoperative temperature measurement by TMS thermometer
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01196663
|Contact: Avi Weissman, MD||972 4 email@example.com|
|Contact: Amit Lehavi, MD||972 4 firstname.lastname@example.org|
|Dept of anesthesiology -Rambam health care campus||Recruiting|
|Haifa, Israel, 31096|
|Contact: Avi Weissman, MD 972 4 854-2487 email@example.com|
|Principal Investigator: Avi Weissman, MD|
|Sub-Investigator: Amit Lehavi, MD|
|Sub-Investigator: Dror Segal, MD|
|Principal Investigator:||Avi Weissman, MD||Rambam Health Care Campus|