Clinical trial NCT01670760: Zero Heat Flux Thermometry System Comparison Trial
Official title: 3M(TM)SpotOn(TM) Temperature Monitoring System Thermometry Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Temperature
Thermosensing
Temperature
Keywords: Deep Tissue Temperature
Zero Heat Flux Thermometry
Thermometry
Core Temperature
Lead sponsor: 3M
Sponsor class: INDUSTRY
First posted: 2012-08-22
Enrollment: 20
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Body Temperature Difference in Degrees Celsius
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburg of the University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Peter J Davis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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citation: 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.
citation: 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.