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

• ClinicalTrials.gov Identifier: NCT02031159
• Recruitment Status: Completed
• First Posted: January 9, 2014
• Last Update Posted: May 16, 2014
• Sponsor: University of Schleswig-Holstein
• Collaborator: 3M
• Information provided by (Responsible Party): PD Dr. Jan Hoecker, University of Schleswig-Holstein

Study Description

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.

Condition or disease
Hypothermia

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 Design

• Study Type: Observational
• Actual Enrollment: 120 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Correlation, Accuracy, Precision and Practicability of Zero Heat Flux Method in Comparison With Sublingual and Nasopharyngeal Temperature Measurement
• Study Start Date: October 2013
• Actual Primary Completion Date: December 2013
• Actual Study Completion Date: December 2013

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. body core temperature (°C) [ Time Frame: body core temperature taken at 15 min after induction of anesthesia ]

Secondary Outcome Measures :

1. body core temperature (°C) [ Time Frame: body core temperature taken at 45 min after induction of anesthesia ]

Other Outcome Measures:

1. body core temperature (°C) [ Time Frame: body core temperature taken at 75 min after induction of anesthesia ]

Eligibility Criteria

• Ages Eligible for Study: 17 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients older than 16 years undergoing elective surgery in either gynecology or trauma surgery with a planned surgery time > 60 min.

Criteria

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

Contacts and Locations

Locations

Germany

Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Anästhesiologie und Operative Intensivmedizin

Kiel, Schleswig-Holstein, Germany, 24105

Sponsors and Collaborators

University of Schleswig-Holstein

3M

Investigators

• Study Director: Jan Hoecker, MD; Klinik fur Anästhesiologie und Operative Intensivmedizin

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Iden T, Horn EP, Bein B, Böhm R, Beese J, Höcker J. Intraoperative temperature monitoring with zero heat flux technology (3M SpotOn sensor) in comparison with sublingual and nasopharyngeal temperature: An observational study. Eur J Anaesthesiol. 2015 Jun;32(6):387-91. doi: 10.1097/EJA.0000000000000232. Erratum in: Eur J Anaesthesiol. 2015 Oct;32(10):747.

• Responsible Party: PD Dr. Jan Hoecker, PD Dr. Jan Höcker, University of Schleswig-Holstein
• ClinicalTrials.gov Identifier: NCT02031159 History of Changes
• Other Study ID Numbers: THER-ZeroHeatFlux
• First Posted: January 9, 2014
• Last Update Posted: May 16, 2014
• Last Verified: May 2014

Keywords provided by PD Dr. Jan Hoecker, University of Schleswig-Holstein:

perioperative hypothermia; zero heat flux; non-invasive measurement of body core temperature

Additional relevant MeSH terms:

Hypothermia; Body Temperature Changes; Signs and Symptoms