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Temple Touch Pro (TTP) Non Invasive Continuous Temperature Measurement System

Sponsor
Medisim Ltd (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01489280
Collaborator
(none)
800
Enrollment
2
Locations
400
Patients Per Site

Study Details

Study Description

Brief Summary

In this study, the body temperatures of men and women undergoing elective surgery will be measured using the Temple Touch Pro. In the operating room, each patient's temperature will be measured with both the Temple Touch Pro and another one or two of the continuous reference methods used clinically for measuring the core temperature.

The Medisim Temple Touch Pro thermometer combines a noninvasive, biocompatible patch and a receiving unit. The former is attached to the skin, while the latter is placed near the patient or the vital signs monitor and receives data from the patch. The core temperature equivalent is displayed. The Medisim Temple Touch Pro is based on the measurements made by conductive sensors that perform skin temperature measurements and then applies a special algorithm in order to calculate the body's temperature.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    800 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Temple Touch Pro (TTP) Non Invasive Continuous Temperature Measurement System.
    Study Start Date :
    May 1, 2012
    Anticipated Primary Completion Date :
    Feb 1, 2014

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:
      The patients will be chosen for the trial if the following criteria are met:

      • Male and female patients scheduled to undergo cardiothoracic surgery and major (surgeries scheduled to last more than 90 minutes) abdominal, vascular and general surgery.

      • The surgical procedure requires temperature monitoring.

      • Informed consent signed by the patient or his legal guardian.

      Exclusion Criteria:
      The patients will be excluded from the trial if one of the following occurs:

      • The medical staff decides that the patient should not participate.

      • Unavailable measurement site in case of operations performed in the head area.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Rambam medical center Haifa Israel
      2 Wolfson Medical Center Holon Israel

      Sponsors and Collaborators

      • Medisim Ltd

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Medisim Ltd
      ClinicalTrials.gov Identifier:
      NCT01489280
      Other Study ID Numbers:
      • 26-115-630
      First Posted:
      Dec 9, 2011
      Last Update Posted:
      Sep 11, 2012
      Last Verified:
      Sep 1, 2012
      Keywords provided by Medisim Ltd
      Temple Touch Pro
      Medisim
      temperature
      surgery

      Study Results

      No Results Posted as of Sep 11, 2012