Accuracy of Zero Heat Flux Cutaneous Temperature in Intensive Care Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Comparison a continuous non-invasive cutaneous temperature using zero-heat flux method
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •minimum 18 years old
- •patients who required core temperature monitoring
排除标准
- •front disrepair
- •refusal to participate
研究组 & 干预措施
PICCO group
干预措施: temperature obtained by the non-invasive method of zero-heat flux (Procedure)
PICCO group
干预措施: esophageal temperature (Procedure)
PICCO group
干预措施: intracerebral temperature (Procedure)
PICCO group
干预措施: arterial temperature (Procedure)
Brain-injured group
干预措施: temperature obtained by the non-invasive method of zero-heat flux (Procedure)
Brain-injured group
干预措施: esophageal temperature (Procedure)
Brain-injured group
干预措施: intracerebral temperature (Procedure)
Hypothermia group
干预措施: esophageal temperature (Procedure)
Hypothermia group
干预措施: intracerebral temperature (Procedure)
Hypothermia group
干预措施: temperature obtained by the non-invasive method of zero-heat flux (Procedure)
Hyperthermia group
干预措施: temperature obtained by the non-invasive method of zero-heat flux (Procedure)
Hyperthermia group
干预措施: esophageal temperature (Procedure)
Hyperthermia group
干预措施: intracerebral temperature (Procedure)
结局指标
主要结局
Comparison a continuous non-invasive cutaneous temperature using zero-heat flux method
时间窗: 5 days
次要结局
未报告次要终点
