Zero Heat Flux Thermometry System Comparison Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01670760
Recruitment Status : Unknown
Verified August 2012 by Arizant Healthcare.
Recruitment status was:  Not yet recruiting
First Posted : August 22, 2012
Last Update Posted : August 22, 2012
Information provided by (Responsible Party):
Arizant Healthcare

August 16, 2012
August 22, 2012
August 22, 2012
August 2012
December 2012   (Final data collection date for primary outcome measure)
Body temperature [ Time Frame: During the surgical procedure only ]
Agreement between simultaneously-acquired nasopharyngeal and forehead deep tissue temperatures will be assessed by Bland and Altman repeated measures technique.
Same as current
No Changes Posted
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Zero Heat Flux Thermometry System Comparison Trial
3M(TM)SpotOn(TM) Temperature Monitoring System Thermometry Trial
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.
Not Provided
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Body Temperature
  • Thermosensing
  • Temperature
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.
Other Name: 3M(TM) SpotOn(TM) temperature monitoring system
Experimental: Zero-Heat-Flux
This is a single arm study. All patients will have deep tissue temperature monitored from the nasopharyngeal and lateral forehead sites simultaneously.
Intervention: Device: Zero-heat-flux thermometry

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
December 2012
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 17 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
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Arizant Healthcare
Arizant Healthcare
Not Provided
Principal Investigator: Peter J Davis, MD Children's Hospital of Pittsburgh of UPMC
Arizant Healthcare
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP