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Accuracy of Zero Heat Flux Cutaneous Temperature in Intensive Care Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02931227
Acronym
TempCore
Enrollment
120
Registered
2016-10-13
Start date
2014-08-31
Completion date
2018-06-30
Last updated
2019-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Temperature, Continuous Non Invasive Cutaneous Temperature, Esophageal Temperature, Intracerebral Temperature, Zero Heat Flux Method

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.

Interventions

PROCEDUREarterial temperature
PROCEDUREtemperature obtained by the non-invasive method of zero-heat flux
PROCEDUREintracerebral temperature

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* front disrepair * refusal to participate

Design outcomes

Primary

MeasureTime frame
Comparison a continuous non-invasive cutaneous temperature using zero-heat flux method5 days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026