Arterial Temperature Clinical Trial
— TempCore| NCT number | NCT02931227 |
| Other study ID # | TempCore |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | August 2014 |
| Est. completion date | June 2018 |
| Verified date | September 2016 |
| Source | Poitiers University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | June 2018 |
| Est. primary completion date | June 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - minimum 18 years old - patients who required core temperature monitoring Exclusion Criteria: - front disrepair - refusal to participate |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de Poitiers | Poitiers |
| Lead Sponsor | Collaborator |
|---|---|
| Poitiers University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Comparison a continuous non-invasive cutaneous temperature using zero-heat flux method | 5 days |