NCT01489280

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Last Updated

September 11, 2012

Status Verified

September 1, 2012

Enrollment Period

1.8 years

First QC Date

December 7, 2011

Last Update Submit

September 9, 2012

Conditions

Body Temperature During Surgery

Keywords

Temple Touch ProMedisimtemperaturesurgery

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ages 0 and up, patients subjected to elective surgery.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rambam medical center

Haifa, Israel

NOT YET RECRUITING

Wolfson Medical Center

Holon, Israel

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2011

First Posted

December 9, 2011

Study Start

May 1, 2012

Primary Completion

February 1, 2014

Last Updated

September 11, 2012

Record last verified: 2012-09

Locations

IL(2)