Body Temperature During Surgery Clinical Trial
— TTPOfficial title:
Temple Touch Pro (TTP) Non Invasive Continuous Temperature Measurement System.
| NCT number | NCT01489280 |
| Other study ID # | 26-115-630 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | December 7, 2011 |
| Last updated | September 9, 2012 |
| Start date | May 2012 |
| Verified date | September 2012 |
| Source | Medisim Ltd |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Observational |
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.
| Status | Recruiting |
| Enrollment | 800 |
| Est. completion date | |
| Est. primary completion date | February 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Israel | Rambam medical center | Haifa | |
| Israel | Wolfson Medical Center | Holon |
| Lead Sponsor | Collaborator |
|---|---|
| Medisim Ltd |
Israel,