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

NCT ID: NCT01196663

Last Updated: 2010-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DEVICE

Esophageal or urinary bladder temperature measurement

Standard temperature measurement as is being measured from patients during surgery today

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Rambam Health Care Campus

Principal Investigators

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Avi Weissman, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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Dept of anesthesiology -Rambam health care campus

Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Avi Weissman, MD

Role: CONTACT

972 4 854-2487

Amit Lehavi, MD

Role: CONTACT

972 4 854-2487

Facility Contacts

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Avi Weissman, MD

Role: primary

972 4 854-2487

Other Identifiers

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TMS-thermometer-CTIL

Identifier Type: -

Identifier Source: org_study_id