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

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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

Study Description
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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.

Study Design
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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
Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02869828


Locations
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France
BOISSON Matthieu
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT02869828     History of Changes
Other Study ID Numbers: TEMPCORE-BLOC
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: June 2016