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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:
ClinicalTrials.gov Identifier:
NCT01670760
First Posted: August 22, 2012
Last Update Posted: August 22, 2012
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.
Information provided by (Responsible Party):
Arizant Healthcare
  Purpose
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 Intervention
Body Temperature Thermosensing Temperature Device: Zero-heat-flux thermometry

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 3M(TM)SpotOn(TM) Temperature Monitoring System Thermometry Trial

Further study details as provided by Arizant Healthcare:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: August 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01670760


Contacts
Contact: Sarah L Cunningham, BS 412-692-5988 cunninghamsl@upmc.edu
Contact: Minh-chau Evans, BS 412-692-5988 evansm2@upmc.edu

Locations
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    mccarthydj@anes.upmc.edu   
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
Arizant Healthcare
Investigators
Principal Investigator: Peter J Davis, MD Children's Hospital of Pittsburgh of UPMC
  More Information

Publications:

Responsible Party: Arizant Healthcare
ClinicalTrials.gov Identifier: NCT01670760     History of Changes
Other Study ID Numbers: 2012-DTT-BS-01
First Submitted: August 16, 2012
First Posted: August 22, 2012
Last Update Posted: August 22, 2012
Last Verified: August 2012

Keywords provided by Arizant Healthcare:
Deep Tissue Temperature
Zero Heat Flux Thermometry
Thermometry
Core Temperature