Zero Heat Flux Thermometry System Comparison Trial

NCT ID: NCT01670760

Last Updated: 2020-09-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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Body Temperature Thermosensing Temperature

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Zero-heat-flux thermometry

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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3M(TM) SpotOn(TM) temperature monitoring system

Eligibility Criteria

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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
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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3M

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter J Davis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19512860 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21444968 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 5548025 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 940402 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9104528 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11032273 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12903922 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 652707 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11419682 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17532957 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14517632 (View on PubMed)

Other Identifiers

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2012-DTT-BS-01

Identifier Type: -

Identifier Source: org_study_id

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