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

Major Surgery in Adult Patients Clinical Trial

— TEMP CORE BLOC  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02869828
• Other study ID #: TEMPCORE-BLOC
• Status: Completed
• Phase: N/A
• First received: June 20, 2016
• Last updated: June 16, 2017
• Start date: June 2015
• Est. completion date: January 2017

Study information

• Verified date: June 2016
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Major Surgery in Adult Patients

Intervention

Device:
• Monitoring by arterial catheter and Spot-on

• Monitoring by oesophagal probe and Spot-on

Locations

Country	Name	City	State
France	BOISSON Matthieu	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	temperature monitoring with Zero-Heath-Flux (SpotOn)		1 day
Primary	temperature monitoring with oesophagal probe (Coviden)		1 day
Primary	temperature monitoring with arterial catheter (PICCO)		1 day