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Trial record 31 of 5965 for:    zero

Accuracy of Zero Heat Flux Cutaneous Temperature in Intensive Care Adults (TempCore)

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ClinicalTrials.gov Identifier: NCT02931227
Recruitment Status : Completed
First Posted : October 13, 2016
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Continuous Non Invasive Cutaneous Temperature Zero Heat Flux Method Esophageal Temperature Arterial Temperature Intracerebral Temperature Procedure: temperature obtained by the non-invasive method of zero-heat flux Procedure: esophageal temperature Procedure: intracerebral temperature Procedure: arterial temperature Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Actual Study Start Date : August 2014
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Arm Intervention/treatment
Experimental: Brain-injured group Procedure: temperature obtained by the non-invasive method of zero-heat flux
Procedure: esophageal temperature
Procedure: intracerebral temperature
Experimental: Hypothermia group Procedure: temperature obtained by the non-invasive method of zero-heat flux
Procedure: esophageal temperature
Procedure: intracerebral temperature
Experimental: Hyperthermia group Procedure: temperature obtained by the non-invasive method of zero-heat flux
Procedure: esophageal temperature
Procedure: intracerebral temperature
Experimental: PICCO group Procedure: temperature obtained by the non-invasive method of zero-heat flux
Procedure: esophageal temperature
Procedure: intracerebral temperature
Procedure: arterial temperature



Primary Outcome Measures :
  1. Comparison a continuous non-invasive cutaneous temperature using zero-heat flux method [ Time Frame: 5 days ]


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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:

  • minimum 18 years old
  • patients who required core temperature monitoring

Exclusion Criteria:

  • front disrepair
  • refusal to participate

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): NCT02931227


Locations
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France
CHU de Poitiers
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital

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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT02931227     History of Changes
Other Study ID Numbers: TempCore
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: September 2016