Working…
ClinicalTrials.gov
ClinicalTrials.gov 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.
 
ClinicalTrials.gov Identifier: NCT02869828
Recruitment Status : Completed
First Posted : August 17, 2016
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Tracking Information
First Submitted Date  ICMJE June 20, 2016
First Posted Date  ICMJE August 17, 2016
Last Update Posted Date June 19, 2017
Study Start Date  ICMJE June 2015
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2016)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02869828 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Central Temperature Monitoring by Zero-heath-flux a Non-invasive Technic Compared to Two Invasive Technic During Surgery
Official Title  ICMJE Not Provided
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Major Surgery in Adult Patients
Intervention  ICMJE
  • Device: Monitoring by arterial catheter and Spot-on
  • Device: Monitoring by oesophagal probe and Spot-on
Study Arms  ICMJE
  • monitoring by arterial catheter and Spot-on
    Intervention: Device: Monitoring by arterial catheter and Spot-on
  • monitoring by oesophagus tube and Spot-on
    Intervention: Device: Monitoring by oesophagal probe and Spot-on
Publications * Boisson M, Alaux A, Kerforne T, Mimoz O, Debaene B, Dahyot-Fizelier C, Frasca D. Intra-operative cutaneous temperature monitoring with zero-heat-flux technique (3M SpotOn) in comparison with oesophageal and arterial temperature: A prospective observational study. Eur J Anaesthesiol. 2018 Nov;35(11):825-830. doi: 10.1097/EJA.0000000000000822.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02869828
Other Study ID Numbers  ICMJE TEMPCORE-BLOC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Poitiers University Hospital
Study Sponsor  ICMJE Poitiers University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Poitiers University Hospital
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP