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Zero Heat Flux Thermometry System Comparison Trial

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Arizant Healthcare.
Recruitment status was:  Not yet recruiting
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
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
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.
 
Unknown status
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   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01670760
2012-DTT-BS-01
No
Not Provided
Not Provided
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