Zero Heat Flux Thermometry System Comparison Trial - Full Text View

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: 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 ] [ 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.

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

Ages Eligible for Study:	up to 17 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Langham GE, Maheshwari A, Contrera K, You J, Mascha E, Sessler DI. Noninvasive temperature monitoring in postanesthesia care units. Anesthesiology. 2009 Jul;111(1):90-6.

Teunissen LP, Klewer J, de Haan A, de Koning JJ, Daanen HA. Non-invasive continuous core temperature measurement by zero heat flux. Physiol Meas. 2011 May;32(5):559-70. Epub 2011 Mar 28.

Fox RH, Solman AJ. A new technique for monitoring the deep body temperature in man from the intact skin surface. J Physiol. 1971 Jan;212(2):8P-10P.

Togwa T, Nemoto T, Yamazaki T, Kobayashi T. A modified internal temperature measurement device. Med Biol Eng. 1976 May;14(3):361-4.

Matsukawa T, Sessler DI, Ozaki M, Hanagata K, Iwashita H, Kumazawa T. Comparison of distal oesophageal temperature with "deep" and tracheal temperatures. Can J Anaesth. 1997 Apr;44(4):433-8.

Harioka T, Matsukawa T, Ozaki M, Nomura K, Sone T, Kakuyama M, Toda H. "Deep-forehead" temperature correlates well with blood temperature. Can J Anaesth. 2000 Oct;47(10):980-3.

Yamakage M, Namiki A. Deep temperature monitoring using a zero-heat-flow method. J Anesth. 2003;17(2):108-15. Review.

Jost U, Hanf K, Köhler CO, Just OH. [A new method for the transcutaneous measurement of deep body temperature during anaesthesia and intensive care (author's transl)]. Prakt Anaesth. 1978 Apr;13(2):144-9. German.

Esamai F, Mining S, Forsberg P, Lewis DH. A comparison of brain, core and skin temperature in children with complicated and uncomplicated malaria. J Trop Pediatr. 2001 Jun;47(3):170-5.

Akata T, Setoguchi H, Shirozu K, Yoshino J. Reliability of temperatures measured at standard monitoring sites as an index of brain temperature during deep hypothermic cardiopulmonary bypass conducted for thoracic aortic reconstruction. J Thorac Cardiovasc Surg. 2007 Jun;133(6):1559-65.

Yamakage M, Iwasaki S, Namiki A. Evaluation of a newly developed monitor of deep body temperature. J Anesth. 2002;16(4):354-7.

Responsible Party:	Arizant Healthcare
ClinicalTrials.gov Identifier:	NCT01670760 History of Changes
Other Study ID Numbers:	2012-DTT-BS-01
Study First Received:	August 16, 2012
Last Updated:	August 17, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Arizant Healthcare:

Deep Tissue Temperature
Zero Heat Flux Thermometry
Thermometry
Core Temperature

ClinicalTrials.gov processed this record on June 18, 2013