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
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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 |
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 |
- 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 ]

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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

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
France | |
BOISSON Matthieu | |
Poitiers, France, 86021 |
Responsible Party: | Poitiers University Hospital |
ClinicalTrials.gov 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 |