Accuracy of Zero Heat Flux Cutaneous Temperature in Intensive Care Adults

NCT02931227 | Completed

• 1 other identifier: TempCore
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Comparison a continuous non-invasive cutaneous temperature using zero-heat flux method

  5 days

Study Arms (4)

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

Interventions

temperature obtained by the non-invasive method of zero-heat flux PROCEDURE

Brain-injured group; Hyperthermia group; Hypothermia group; PICCO group

esophageal temperature PROCEDURE

Brain-injured group; Hyperthermia group; Hypothermia group; PICCO group

intracerebral temperature PROCEDURE

Brain-injured group; Hyperthermia group; Hypothermia group; PICCO group

arterial temperature PROCEDURE

PICCO group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• front disrepair
• refusal to participate

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU de Poitiers

Poitiers, 86021, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: October 13, 2016
• Study Start: August 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: January 28, 2019

Record last verified: 2016-09

Locations

FR (1)