Zero Heat Flux Thermometry System Comparison Trial

Body Temperature Clinical Trial

Official title:

3M(TM)SpotOn(TM) Temperature Monitoring System Thermometry Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01670760
• Other study ID #: 2012-DTT-BS-01
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: June 2013

Study information

• Verified date: September 2020
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Temperature
• Temperature
• Thermosensing

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital of Pittsburg of the University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
3M

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. — View 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. — View Citation

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

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

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

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.