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NCT02031159 Clinical Trial

Correlation, Accuracy, Precision and Practicability of Zero Heat Flux Temperature Monitoring

Hypothermia Clinical Trial

Official title:
Correlation, Accuracy, Precision and Practicability of Zero Heat Flux Method in Comparison With Sublingual and Nasopharyngeal Temperature Measurement

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02031159
Other study ID # THER-ZeroHeatFlux
Secondary ID
Status Completed
Phase N/A
First received January 1, 2014
Last updated May 15, 2014
Start date October 2013
Est. completion date December 2013

Study information
Verified date May 2014
Source University of Schleswig-Holstein
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

Hypothermia is common in patients undergoing general anesthesia. There have been several negative outcomes reported. Zero heat flux is a non-invasive method for measurement of body core temperature. The aim of this study is to see if this method is comparable in terms of correlation, accuracy, precision and practicability to commonly used sublingual and nasopharyngeal temperature monitoring.

Description:

Hypothermia is common in patients undergoing general anesthesia. There have been several negative outcomes reported such as bleeding, infection rate, cardiac complications, prolonged wound healing and patient discomfort. Zero heat flux is a non-invasive method for measurement of body core temperature. The aim of this study is to see if this method is comparable in terms of correlation, accuracy, precision and practicability to commonly used sublingual and nasopharyngeal temperature monitoring. Measurements are performed with the SpotOn® sensor by Arizant Healthcare, Inc..

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 17 Years and older
Eligibility Inclusion Criteria:

- elective surgery in gynecology or trauma surgery

- planned surgery time > 60 min

- patients older than 16 years

Exclusion Criteria:

- emergency surgery

- need for post-surgery ventilation

- patient's denial to take part in the study

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Anästhesiologie und Operative Intensivmedizin Kiel Schleswig-Holstein

Sponsors (2)
Lead Sponsor Collaborator
University of Schleswig-Holstein Arizant Healthcare

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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

Outcome
Type Measure Description Time frame Safety issue
Other body core temperature (°C) body core temperature taken at 75 min after induction of anesthesia No
Primary body core temperature (°C) body core temperature taken at 15 min after induction of anesthesia No
Secondary body core temperature (°C) body core temperature taken at 45 min after induction of anesthesia No
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