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

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 Overview

• Status: Completed
• Conditions: Continuous Non Invasive Cutaneous Temperature; Zero Heat Flux Method; Esophageal Temperature; Arterial Temperature; Intracerebral Temperature
• Intervention / Treatment: Procedure: temperature obtained by the non-invasive method of zero-heat flux; Procedure: esophageal temperature; Procedure: intracerebral temperature; Procedure: arterial temperature

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86021
    • CHU de Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• front disrepair
• refusal to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison a continuous non-invasive cutaneous temperature using zero-heat flux method	5 days

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: September 5, 2016
• First Submitted That Met QC Criteria: October 10, 2016
• First Posted (Estimate): October 13, 2016

Study Record Updates

• Last Update Posted (Actual): January 28, 2019
• Last Update Submitted That Met QC Criteria: January 25, 2019
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: TempCore