Working… Menu

Central Temperature Monitoring by Zero-heath-flux a Non-invasive Technic Compared to Two Invasive Technic During Surgery (TEMP CORE BLOC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02869828
Recruitment Status : Completed
First Posted : August 17, 2016
Last Update Posted : June 19, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Major Surgery in Adult Patients Device: Monitoring by arterial catheter and Spot-on Device: Monitoring by oesophagal probe and Spot-on Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Study Start Date : June 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Arm Intervention/treatment
monitoring by arterial catheter and Spot-on Device: Monitoring by arterial catheter and Spot-on
monitoring by oesophagus tube and Spot-on Device: Monitoring by oesophagal probe and Spot-on

Primary Outcome Measures :
  1. temperature monitoring with Zero-Heath-Flux (SpotOn) [ Time Frame: 1 day ]
  2. temperature monitoring with oesophagal probe (Coviden) [ Time Frame: 1 day ]
  3. temperature monitoring with arterial catheter (PICCO) [ Time Frame: 1 day ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02869828

Layout table for location information
BOISSON Matthieu
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Poitiers University Hospital Identifier: NCT02869828    
Other Study ID Numbers: TEMPCORE-BLOC
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: June 2016