Central Temperature Monitoring by Zero-heath-flux a Non-invasive Technic Compared to Two Invasive Technic During Surgery
TEMP CORE BLOC
1 other identifier
interventional
50
1 country
1
Brief Summary
Core temperature monitoring is mandatory during major surgery. The accurate techniques currently used are invasive, such as artery catheter and oesophagal probe. A new non-invasive cutaneous device, 3M SpotOn, using Zero Heath-Flux method, continuously measure core temperature. This prospective study compare the accuracy of Zero-Heath-Flux to oesophagal temperature (30 patients) and to artery catheter (20 patients) in adult patients during surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 20, 2016
CompletedFirst Posted
Study publicly available on registry
August 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedJune 19, 2017
June 1, 2016
1.6 years
June 20, 2016
June 16, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
temperature monitoring with Zero-Heath-Flux (SpotOn)
1 day
temperature monitoring with oesophagal probe (Coviden)
1 day
temperature monitoring with arterial catheter (PICCO)
1 day
Study Arms (2)
monitoring by arterial catheter and Spot-on
OTHERmonitoring by oesophagus tube and Spot-on
OTHERInterventions
Eligibility Criteria
You may qualify if:
- Patients scheduled to undergo general anaesthesia for gut surgery lasting more than 2 hours
- Patients with core temperature monitored with oesophagal probe only (30 patients) or with oesophagal probe and PICCO device (20 patients)
- Patients without opposition to this study after informations given
You may not qualify if:
- Patients with frontal cutaneous decay wich avoid using 3M Spot-on
- Patients whom oesophagal probe was prohibited (oesophagal varices, oesophagal surgery)
- Pregnant women or breast-feeding, women who may become pregnant unless adequate contraceptive measures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BOISSON Matthieu
Poitiers, 86021, France
Related Publications (1)
Boisson M, Alaux A, Kerforne T, Mimoz O, Debaene B, Dahyot-Fizelier C, Frasca D. Intra-operative cutaneous temperature monitoring with zero-heat-flux technique (3M SpotOn) in comparison with oesophageal and arterial temperature: A prospective observational study. Eur J Anaesthesiol. 2018 Nov;35(11):825-830. doi: 10.1097/EJA.0000000000000822.
PMID: 29708906DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2016
First Posted
August 17, 2016
Study Start
June 1, 2015
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
June 19, 2017
Record last verified: 2016-06