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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Major Surgery in Adult Patients

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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monitoring by arterial catheter and Spot-on

Group Type OTHER

Monitoring by arterial catheter and Spot-on

Intervention Type DEVICE

monitoring by oesophagus tube and Spot-on

Group Type OTHER

Monitoring by oesophagal probe and Spot-on

Intervention Type DEVICE

Interventions

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Monitoring by arterial catheter and Spot-on

Intervention Type DEVICE

Monitoring by oesophagal probe and Spot-on

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No