Zero Heat Flux Thermometry System Comparison Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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3M(TM)SpotOn(TM) Temperature Monitoring System Thermometry Trial

Conditions
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Body Temperature, Thermosensing, Temperature

Intervention / Treatment
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* Device: Zero-heat-flux thermometry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zero-Heat-Flux<br>This is a single arm study. All patients will have deep tissue temperature monitored from the nasopharyngeal and lateral forehead sites simultaneously. | Device: Zero-heat-flux thermometry<br>* 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.<br>* Other names: 3M(TM) SpotOn(TM) temperature monitoring system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep Tissue Temperature, Zero Heat Flux Thermometry, Thermometry, Core Temperature