Zero Heat Flux Thermometry System Comparison Trial

This study is not yet open for participant recruitment.
Verified August 2012 by Arizant Healthcare
Sponsor:
Information provided by (Responsible Party):
Arizant Healthcare
ClinicalTrials.gov Identifier:
NCT01670760
First received: August 16, 2012
Last updated: August 17, 2012
Last verified: August 2012

August 16, 2012
August 17, 2012
August 2012
December 2012   (final data collection date for primary outcome measure)
Body temperature [ Time Frame: During the surgical procedure only ] [ Designated as safety issue: No ]
Agreement between simultaneously-acquired nasopharyngeal and forehead deep tissue temperatures will be assessed by Bland and Altman repeated measures technique.
Same as current
Complete list of historical versions of study NCT01670760 on ClinicalTrials.gov Archive Site
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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
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
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
Both
up to 17 Years
No
Contact: Sarah L Cunningham, BS 412-692-5988 cunninghamsl@upmc.edu
Contact: Minh-chau Evans, BS 412-692-5988 evansm2@upmc.edu
United States
 
NCT01670760
2012-DTT-BS-01
No
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