Clinical trial NCT02031159: Correlation, Accuracy, Precision and Practicability of Zero Heat Flux Temperature Monitoring
Official title: Correlation, Accuracy, Precision and Practicability of Zero Heat Flux Method in Comparison With Sublingual and Nasopharyngeal Temperature Measurement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothermia
Keywords: perioperative hypothermia
zero heat flux
non-invasive measurement of body core temperature
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: 3M
First posted: 2014-01-09
Enrollment: 120
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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..

Eligibility 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

Primary outcomes:
measure: body core temperature (°C)
timeFrame: body core temperature taken at 15 min after induction of anesthesia
Secondary outcomes:
measure: body core temperature (°C)
timeFrame: body core temperature taken at 45 min after induction of anesthesia
Other outcomes:
measure: body core temperature (°C)
timeFrame: body core temperature taken at 75 min after induction of anesthesia
Locations:
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Anästhesiologie und Operative Intensivmedizin
state: Schleswig-Holstein
Study officials:
affiliation: Klinik fur Anästhesiologie und Operative Intensivmedizin
name: Jan Hoecker, MD
role: STUDY_DIRECTOR
References:
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.
citation: Iden T, Horn EP, Bein B, Bohm R, Beese J, Hocker 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.