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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Medisim Ltd
Sponsor:
Information provided by (Responsible Party):
Medisim Ltd
ClinicalTrials.gov Identifier:
NCT01489280
First received: December 7, 2011
Last updated: September 9, 2012
Last verified: September 2012
  Purpose

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
Body Temperature During Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Temple Touch Pro (TTP) Non Invasive Continuous Temperature Measurement System.

Further study details as provided by Medisim Ltd:

Estimated Enrollment: 800
Study Start Date: May 2012
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

ages 0 and up, patients subjected to elective surgery.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01489280

Locations
Israel
Rambam medical center Not yet recruiting
Haifa, Israel
Contact: Avraham Weissman    97248542381      
Wolfson Medical Center Recruiting
Holon, Israel
Contact: Shmuel Evron, Prof.    97235028152      
Sponsors and Collaborators
Medisim Ltd
  More Information

No publications provided

Responsible Party: Medisim Ltd
ClinicalTrials.gov Identifier: NCT01489280     History of Changes
Other Study ID Numbers: 26-115-630
Study First Received: December 7, 2011
Last Updated: September 9, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Medisim Ltd:
Temple Touch Pro
Medisim
temperature
surgery

ClinicalTrials.gov processed this record on July 28, 2014