Zero Heat Flux Thermometry System Comparison Trial

NCT01670760 | Completed Results

• 1 other identifier: 2012-DTT-BS-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Body Temperature; Thermosensing; Temperature

Keywords

Deep Tissue Temperature; Zero Heat Flux Thermometry; Thermometry; Core Temperature

Outcome Measures

Primary Outcomes (1)

• Body Temperature Difference in Degrees Celsius

  Body temperature difference as defined by Agreement (bias - Zero heat flux thermometry minus nasopharyngeal) between simultaneously-acquired nasopharyngeal and forehead deep tissue temperatures as assessed by Bland and Altman repeated measures technique.

  Every 5 to 10 minutes, or as clinically indicated, for the duration of the surgery from the time of incision to the time of closure. The average duration of surgery was 57 minutes.

Study Arms (1)

Zero-Heat-Flux

EXPERIMENTAL

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

Interventions

Zero-heat-flux thermometry DEVICE

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.

Also known as: 3M(TM) SpotOn(TM) temperature monitoring system

Zero-Heat-Flux

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• 3M: lead

Study Sites (1)

Children's Hospital of Pittsburg of the University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15241, United States

Location

Related Publications (11)

• 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. doi: 10.1097/ALN.0b013e3181a864ca.

  PMID: 19512860 BACKGROUND

• 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. doi: 10.1088/0967-3334/32/5/005. Epub 2011 Mar 28.

  PMID: 21444968 BACKGROUND

• 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. No abstract available.

  PMID: 5548025 BACKGROUND

• Togwa T, Nemoto T, Yamazaki T, Kobayashi T. A modified internal temperature measurement device. Med Biol Eng. 1976 May;14(3):361-4. doi: 10.1007/BF02478138. No abstract available.

  PMID: 940402 BACKGROUND

• 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. doi: 10.1007/BF03014466.

  PMID: 9104528 BACKGROUND

• 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. doi: 10.1007/BF03024869.

  PMID: 11032273 BACKGROUND

• Yamakage M, Namiki A. Deep temperature monitoring using a zero-heat-flow method. J Anesth. 2003;17(2):108-15. doi: 10.1007/s005400300026. No abstract available.

  PMID: 12903922 BACKGROUND

• Jost U, Hanf K, Kohler 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.

  PMID: 652707 BACKGROUND

• 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. doi: 10.1093/tropej/47.3.170.

  PMID: 11419682 BACKGROUND

• 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. doi: 10.1016/j.jtcvs.2006.11.031.

  PMID: 17532957 BACKGROUND

• Yamakage M, Iwasaki S, Namiki A. Evaluation of a newly developed monitor of deep body temperature. J Anesth. 2002;16(4):354-7. doi: 10.1007/s005400200056. No abstract available.

  PMID: 14517632 BACKGROUND

Results Point of Contact

• Title: Terri White
• Organization: 3M

twhite3@mmm.com

651-733-0228

Study Officials

• Peter J Davis, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: August 22, 2012
• Study Start: April 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 22, 2020
• Results First Posted: August 21, 2020

Record last verified: 2020-09

Locations

US (1)