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Completed

NCT Number: NCT01670760

Zero Heat Flux Thermometry System Comparison Trial

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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Key information

Conditions

Body Temperature Temperature Thermosensing

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Pittsburg of the University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15241, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zero-heat-flux thermometry

Device

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.

Other names: 3M(TM) SpotOn(TM) temperature monitoring system

Primary outcomes

  1. Body Temperature Difference in Degrees Celsius

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

3M

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 22, 2012
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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