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

Medisim

Status: Unknown

Conditions: Body Temperature During Surgery

Study type: Observational

Funder types: Industry

Identifiers

NCT01489280

26-115-630

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.