Major Surgery in Adult PatientsTEMP CORE BLOCNCT02869828
Central Temperature Monitoring by Zero-heath-flux a Non-invasive Technic Compared to Two Invasive Technic During Surgery
A study testing Monitoring by arterial catheter and Spot-on and Monitoring by oesophagal probe and Spot-on in people with Major Surgery in Adult Patients, run by Poitiers University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Surgery in Adult Patients
- What is being tested?
- Monitoring by arterial catheter and Spot-on and Monitoring by oesophagal probe and Spot-on
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Major Surgery in Adult Patients
- Being tested
- Monitoring by arterial catheter and Spot-on, Monitoring by oesophagal probe and Spot-on
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring by arterial catheter and Spot-onDevice
Monitoring by oesophagal probe and Spot-onDevice
| Study group | Role | What they receive |
|---|---|---|
| monitoring by arterial catheter and Spot-on | Other | Not described Receives: Device: Monitoring by arterial catheter and Spot-on |
| monitoring by oesophagus tube and Spot-on | Other | Not described Receives: Device: Monitoring by oesophagal probe and Spot-on |
What is being measured
The primary outcome is the main question the study is designed to answer.
temperature monitoring with Zero-Heath-Flux (SpotOn)
Measured: 1 day
temperature monitoring with oesophagal probe (Coviden)
Measured: 1 day
temperature monitoring with arterial catheter (PICCO)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startJun 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Surgery in Adult PatientsStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869828
- Sponsor's protocol ID
- TEMPCORE-BLOC
- Acronym
- TEMP CORE BLOC
- Status last verified
- Jun 2016
- First submitted
- 20 Jun 2016
- Last updated
- 19 Jun 2017
- Results posted
- No
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.
PubMed 29708906
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Temperature Monitoring by Zero-heath-flux a Non-invasive Technic Compared to Two Invasive Technic During Surgery
- ClinicalTrials.gov ID
- NCT02869828
- Acronym / sponsor ID
- TEMP CORE BLOC / TEMPCORE-BLOC
- Conditions
- Major Surgery in Adult Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 17 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| monitoring by arterial catheter and Spot-on | Other | Device: Monitoring by arterial catheter and Spot-on |
| monitoring by oesophagus tube and Spot-on | Other | Device: Monitoring by oesophagal probe and Spot-on |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring by arterial catheter and Spot-on | Device | monitoring by arterial catheter and Spot-on |
| Monitoring by oesophagal probe and Spot-on | Device | monitoring by oesophagus tube and Spot-on |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2017.
- Derived from this study: PubMed 29708906Boisson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring by arterial catheter and Spot-on and Monitoring by oesophagal probe and Spot-on in people with Major Surgery in Adult Patients, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
temperature monitoring with Zero-Heath-Flux (SpotOn) (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02869828, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2017.