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Clinical Trials/NCT02869828
NCT02869828
Completed
Not Applicable

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

Poitiers University Hospital1 site in 1 country50 target enrollmentJune 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Surgery in Adult Patients
Sponsor
Poitiers University Hospital
Enrollment
50
Locations
1
Primary Endpoint
temperature monitoring with Zero-Heath-Flux (SpotOn)
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
January 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

temperature monitoring with Zero-Heath-Flux (SpotOn)

Time Frame: 1 day

temperature monitoring with oesophagal probe (Coviden)

Time Frame: 1 day

temperature monitoring with arterial catheter (PICCO)

Time Frame: 1 day

Study Sites (1)

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