Continuous Non Invasive Cutaneous TemperatureTempCoreNCT02931227
Accuracy of Zero Heat Flux Cutaneous Temperature in Intensive Care Adults
A study testing temperature obtained by the non-invasive method of zero-heat flux, esophageal temperature and intracerebral temperature in people with Continuous Non Invasive Cutaneous Temperature and Zero Heat Flux Method, run by Poitiers University Hospital at 1 site in France.
Trial summary
Temperature is one of the vital signs usually monitored in patients of ICUs. Indeed, fever occurs frequently in ICU especially in brain injured patients and may require targeted temperature management (TTM) in special case as intracranial hypertension or post cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Continuous Non Invasive Cutaneous Temperature, Zero Heat Flux Method, Esophageal Temperature
- What is being tested?
- temperature obtained by the non-invasive method of zero-heat flux, esophageal temperature and intracerebral temperature
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2014to Jun 2018
- 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
- minimum 18 years old
- patients who required core temperature monitoring
Who cannot join
- front disrepair
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Temperature is one of the vital signs usually monitored in patients of ICUs. Indeed, fever occurs frequently in ICU especially in brain injured patients and may require targeted temperature management (TTM) in special case as intracranial hypertension or post cardiac arrest. In ICU, non invasive device to monitor temperature are not recommended and only invasive ones are accurate enough for TTM. Arterial pulmonary temperature is still the gold standard, but esophageal device is currently used in ICU patients.
The goal of this study is to compare accuracy of a continuous noninvasive cutaneous temperature using zero-heat-flux (ZHF) method to esophageal temperature, arterial temperature and intracerebral temperature if present for clinical monitoring.
Read more
All adults patients admitted in the neurosurgical or surgical ICU are eligible for inclusion into this study.
Assessment of temperature will be continuously monitored by esophageal probe (MON-A-THERM, 12Fr, COVIDIEN, Dublin, Ireland) (Teso), ZHF sensor (SpotOn, 3M, St Paul, MN, USA) (TZHF) and, in patients requiring cardiac output monitoring, by femoral arterial catheter (Pulsiocath PICCO, PULSION, Munich, Germany) (Tart). The correct positioning of the esophageal probe will be controlled by chest X-ray. The ZHF temperature sensor (TZHF) will be placed on the forehead as recommend by the manufacturer and connected to the SpotOn monitor. Intra cerebral temperature (Tbrain) will be obtained with an intracranial probe used as calibrator for partial pressure of O2 in brain (PbO2, Licox®Combined Oxygen and Temperature Probe 462 mm device necessary for monitoring severe brain injured patients. The ZHF sensor will be changed every 24 hours according to the manufacturer's directions for use. Temperatures will be recorded automatically at a 5-minutes interval via the patient's monitor with an electronic data acquisition system (Data Collect, Phillips) for a maximum of 5 days.
For each patient included, data recorded will be: demographic and clinical particulars for each patient; information on hemodynamics, sedative, analgesic and inotropic agents, use of neuromuscular blockades and their indication, reason of hypo or hyperthermia (spontaneous or therapeutic), indication and the means used (neuromuscular blockades, external or internal cooling) in case of Targeted Temperature Management; complications related to the ZHF sensor application.
- Conditions
- Continuous Non Invasive Cutaneous Temperature, Zero Heat Flux Method, Esophageal Temperature, Arterial Temperature, Intracerebral Temperature
- Being tested
- temperature obtained by the non-invasive method of zero-heat flux, esophageal temperature, intracerebral temperature, arterial temperature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temperature obtained by the non-invasive method of zero-heat fluxProcedure or surgery
esophageal temperatureProcedure or surgery
intracerebral temperatureProcedure or surgery
arterial temperatureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Brain-injured group | Experimental | Not described Receives: Procedure: temperature obtained by the non-invasive method of zero-heat flux; Procedure: esophageal temperature; Procedure: intracerebral temperature |
| Hypothermia group | Experimental | Not described Receives: Procedure: temperature obtained by the non-invasive method of zero-heat flux; Procedure: esophageal temperature; Procedure: intracerebral temperature |
| Hyperthermia group | Experimental | Not described Receives: Procedure: temperature obtained by the non-invasive method of zero-heat flux; Procedure: esophageal temperature; Procedure: intracerebral temperature |
| PICCO group | Experimental | Not described Receives: Procedure: temperature obtained by the non-invasive method of zero-heat flux; Procedure: esophageal temperature; Procedure: intracerebral temperature; Procedure: arterial temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison a continuous non-invasive cutaneous temperature using zero-heat flux method
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startAug 2014
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Non Invasive Cutaneous TemperatureStudies 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
- 120 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
- NCT02931227
- Sponsor's protocol ID
- TempCore
- Acronym
- TempCore
- Status last verified
- Sep 2016
- First submitted
- 5 Sep 2016
- Last updated
- 28 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Zero Heat Flux Cutaneous Temperature in Intensive Care Adults
- ClinicalTrials.gov ID
- NCT02931227
- Acronym / sponsor ID
- TempCore / TempCore
- Conditions
- Continuous Non Invasive Cutaneous Temperature, Zero Heat Flux Method, Esophageal Temperature, Arterial Temperature, Intracerebral Temperature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 13 Oct 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.
Temperature is one of the vital signs usually monitored in patients of ICUs. Indeed, fever occurs frequently in ICU especially in brain injured patients and may require targeted temperature management (TTM) in special case as intracranial hypertension or post cardiac arrest. In ICU, non invasive device to monitor temperature are not recommended and only invasive ones are accurate enough for TTM. Arterial pulmonary temperature is still the gold standard, but esophageal device is currently used in ICU patients.
The goal of this study is to compare accuracy of a continuous noninvasive cutaneous temperature using zero-heat-flux (ZHF) method to esophageal temperature, arterial temperature and intracerebral temperature if present for clinical monitoring.
All adults patients admitted in the neurosurgical or surgical ICU are eligible for inclusion into this study.
Assessment of temperature will be continuously monitored by esophageal probe (MON-A-THERM, 12Fr, COVIDIEN, Dublin, Ireland) (Teso), ZHF sensor (SpotOn, 3M, St Paul, MN, USA) (TZHF) and, in patients requiring cardiac output monitoring, by femoral arterial catheter (Pulsiocath PICCO, PULSION, Munich, Germany) (Tart). The correct positioning of the esophageal probe will be controlled by chest X-ray. The ZHF temperature sensor (TZHF) will be placed on the forehead as recommend by the manufacturer and connected to the SpotOn monitor. Intra cerebral temperature (Tbrain) will be obtained with an intracranial probe used as calibrator for partial pressure of O2 in brain (PbO2, Licox®Combined Oxygen and Temperature Probe 462 mm device necessary for monitoring severe brain injured patients. The ZHF sensor will be changed every 24 hours according to the manufacturer's directions for use. Temperatures will be recorded automatically at a 5-minutes interval via the patient's monitor with an electronic data acquisition system (Data Collect, Phillips) for a maximum of 5 days.
For each patient included, data recorded will be: demographic and clinical particulars for each patient; information on hemodynamics, sedative, analgesic and inotropic agents, use of neuromuscular blockades and their indication, reason of hypo or hyperthermia (spontaneous or therapeutic), indication and the means used (neuromuscular blockades, external or internal cooling) in case of Targeted Temperature Management; complications related to the ZHF sensor application.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Brain-injured group | Experimental | Procedure: temperature obtained by the non-invasive method of zero-heat flux, Procedure: esophageal temperature, Procedure: intracerebral temperature |
| Hypothermia group | Experimental | Procedure: temperature obtained by the non-invasive method of zero-heat flux, Procedure: esophageal temperature, Procedure: intracerebral temperature |
| Hyperthermia group | Experimental | Procedure: temperature obtained by the non-invasive method of zero-heat flux, Procedure: esophageal temperature, Procedure: intracerebral temperature |
| PICCO group | Experimental | Procedure: temperature obtained by the non-invasive method of zero-heat flux, Procedure: esophageal temperature, Procedure: intracerebral temperature, Procedure: arterial temperature |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- minimum 18 years old
- patients who required core temperature monitoring
Key exclusion criteria (2 listed)
- front disrepair
- refusal to participate
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 |
|---|---|---|
| temperature obtained by the non-invasive method of zero-heat flux | Procedure or surgery | Brain-injured group, Hyperthermia group, Hypothermia group, PICCO group |
| esophageal temperature | Procedure or surgery | Brain-injured group, Hyperthermia group, Hypothermia group, PICCO group |
| intracerebral temperature | Procedure or surgery | Brain-injured group, Hyperthermia group, Hypothermia group, PICCO group |
| arterial temperature | Procedure or surgery | PICCO group |
Primary outcome
Comparison a continuous non-invasive cutaneous temperature using zero-heat flux method
Time frame: 5 days
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 28 Jan 2019.
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 temperature obtained by the non-invasive method of zero-heat flux, esophageal temperature and intracerebral temperature in people with Continuous Non Invasive Cutaneous Temperature and Zero Heat Flux Method, 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 2 inclusion and 2 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 28 Jan 2019. 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?
Comparison a continuous non-invasive cutaneous temperature using zero-heat flux method (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2019.