Zero Heat Flux Thermometry System Comparison Trial

Not Applicable

Completed

• Conditions: Thermosensing; Body Temperature; Temperature
• Interventions: Device: Zero-heat-flux thermometry

• Registration Number: NCT01670760
• Lead Sponsor: 3M

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2012-08-16
• Study First Submitted QC: 2012-08-17
• Study First Posted: 2012-08-22
• Study Start: 2013-04
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Results First Submitted: 2019-08-12
• Results First Submitted QC: 2020-08-11
• Results First Posted: 2020-08-21
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Less than or equal to 17 years old
• patients undergoing surgery during which core temperature is estimated
• Willing to participate in trial
• Able to provide consent
• Adequate forehead surface area available for probe attachment
• Urology, orthopedic, or general abdominal surgery

Exclusion Criteria

• Skin lesions at thermometer target site
• Infectious disease
• Bleeding disorder
• Prone intraoperative positioning anticipated
• Head and neck procedures
• Cardiothoracic procedures
• Tonsillectomy, cosmetic, or other brief surgical or nonsurgical procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zero-Heat-Flux	Zero-heat-flux thermometry	This is a single arm study. All patients will have deep tissue temperature monitored from the nasopharyngeal and lateral forehead sites simultaneously.

Primary Outcome Measures

Name	Time	Method
Body Temperature Difference in Degrees Celsius	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.	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.

Trial Locations

Locations (1)

Children's Hospital of Pittsburg of the University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States