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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 3M.
Recruitment status was:  Not yet recruiting
First Posted : August 22, 2012
Last Update Posted : August 22, 2012
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Body Temperature Thermosensing Temperature Device: Zero-heat-flux thermometry Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 3M(TM)SpotOn(TM) Temperature Monitoring System Thermometry Trial
Study Start Date : August 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Arm Intervention/treatment
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.
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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01670760

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Contact: Sarah L Cunningham, BS 412-692-5988
Contact: Minh-chau Evans, BS 412-692-5988

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United States, Pennsylvania
Children's Hospital of Pittsburg of the University of Pittsburgh Medical Center Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15241
Contact: Denise L McCarthy, BSN    412-692-5585   
Principal Investigator: Peter J Davis, MD         
Sub-Investigator: Jay B Tuchman, MD         
Sub-Investigator: Neal F Campbell, MD         
Sub-Investigator: Franklyn P Cladis, MD         
Sponsors and Collaborators
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Principal Investigator: Peter J Davis, MD University of Pittsburgh


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Responsible Party: 3M Identifier: NCT01670760     History of Changes
Other Study ID Numbers: 2012-DTT-BS-01
First Posted: August 22, 2012    Key Record Dates
Last Update Posted: August 22, 2012
Last Verified: August 2012
Keywords provided by 3M:
Deep Tissue Temperature
Zero Heat Flux Thermometry
Core Temperature