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

Completed

• Conditions: Hypothermia

• Registration Number: NCT02031159
• Lead Sponsor: University Hospital Schleswig-Holstein

Brief 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.

Detailed 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..

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2014-01-01
• Study First Submitted QC: 2014-01-07
• Study First Posted: 2014-01-09
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-15
• Last Update Posted: 2014-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
body core temperature (°C)	body core temperature taken at 15 min after induction of anesthesia

Secondary Outcome Measures

Name	Time	Method
body core temperature (°C)	body core temperature taken at 45 min after induction of anesthesia

Trial Locations

Locations (1)

Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Anästhesiologie und Operative Intensivmedizin; 🇩🇪 Kiel, Schleswig-Holstein, Germany