Central Temperature Monitoring by Zero-heath-flux a Non-invasive Technic Compared to Two Invasive Technic During Surgery

Not Applicable

Completed

• Conditions: Major Surgery in Adult Patients
• Interventions: Device: Monitoring by arterial catheter and Spot-on; Device: Monitoring by oesophagal probe and Spot-on

• Registration Number: NCT02869828
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Every patients undergoing heavy surgery had their central temperature monitoring, through an arterial catheter if the surgery required it (30 patients in this arm), otherwise the investigators used an oesophagus tube (20 patients). We also monitored every 50 patients with a non-invasive method 3M spot on (Zero-heath-flux technic) in order to measure its fiability and validity during the surgery.

Study Timeline

• Study Start: 2015-06
• Status Verified: 2016-06
• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2016-08-11
• Study First Posted: 2016-08-17
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-06-16
• Last Update Posted: 2017-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
monitoring by arterial catheter and Spot-on	Monitoring by arterial catheter and Spot-on	-
monitoring by oesophagus tube and Spot-on	Monitoring by oesophagal probe and Spot-on	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

BOISSON Matthieu; 🇫🇷 Poitiers, France