Accuracy of Zero Heat Flux Cutaneous Temperature in Intensive Care Adults
NCT ID: NCT02931227
Last Updated: 2019-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2014-08-31
2018-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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Brain-injured group
temperature obtained by the non-invasive method of zero-heat flux
esophageal temperature
intracerebral temperature
Hypothermia group
temperature obtained by the non-invasive method of zero-heat flux
esophageal temperature
intracerebral temperature
Hyperthermia group
temperature obtained by the non-invasive method of zero-heat flux
esophageal temperature
intracerebral temperature
PICCO group
temperature obtained by the non-invasive method of zero-heat flux
esophageal temperature
intracerebral temperature
arterial temperature
Interventions
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temperature obtained by the non-invasive method of zero-heat flux
esophageal temperature
intracerebral temperature
arterial temperature
Eligibility Criteria
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Inclusion Criteria
* patients who required core temperature monitoring
Exclusion Criteria
* refusal to participate
18 Years
ALL
No
Sponsors
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Poitiers University Hospital
OTHER
Responsible Party
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Locations
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CHU de Poitiers
Poitiers, , France
Countries
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Other Identifiers
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TempCore
Identifier Type: -
Identifier Source: org_study_id
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