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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01670760
Other study ID # 2012-DTT-BS-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2013
Est. completion date June 2013

Study information

Verified date September 2020
Source 3M
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Nasopharyngeal and deep tissue temperatures will be measured simultaneously during surgery and compared for agreement. The hypothesis of this trial is that deep tissue temperature as measured by zero-heat-flux thermometry will agree with nasopharyngeal temperatures during surgery.


Description:

The core temperature of the body normally decreases in response to anesthesia. Deep tissue temperature can be used to estimate of body core temperature. Deep tissue temperature of the forehead will be measured using a new technology known as zero-heat-flux thermometry. The usual way to measure internal body temperature is within the nasal cavity (nasopharyngeal temperature). Nasopharyngeal and deep tissue temperatures will be measured simultaneously during surgery and compared for agreement. The hypothesis of this trial is that deep tissue temperature as measured by zero-heat-flux thermometry will agree with nasopharyngeal temperatures during surgery.


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Study Design


Related Conditions & MeSH terms


Intervention

Device:
Zero-heat-flux thermometry
The zero-heat-flux thermometer will be placed on the subject's lateral forehead for the duration of the surgery to measure deep tissue temperature.

Locations

Country Name City State
United States Children's Hospital of Pittsburg of the University of Pittsburgh Medical Center Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
3M

Country where clinical trial is conducted

United States, 

References & Publications (11)

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Outcome

Type Measure Description Time frame Safety issue
Primary Body Temperature Difference in Degrees Celsius Body temperature difference as defined by Agreement (bias - Zero heat flux thermometry minus nasopharyngeal) between simultaneously-acquired nasopharyngeal and forehead deep tissue temperatures as assessed by Bland and Altman repeated measures technique. Every 5 to 10 minutes, or as clinically indicated, for the duration of the surgery from the time of incision to the time of closure. The average duration of surgery was 57 minutes.
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