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临床试验/NCT02931227
NCT02931227已完成不适用

Accuracy of Zero Heat Flux Cutaneous Temperature in Intensive Care Adults

Poitiers University Hospital2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年8月最近更新:
适应症
干预措施

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

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

Experimental

干预措施: temperature obtained by the non-invasive method of zero-heat flux (Procedure)

PICCO group

Experimental

干预措施: esophageal temperature (Procedure)

PICCO group

Experimental

干预措施: intracerebral temperature (Procedure)

PICCO group

Experimental

干预措施: arterial temperature (Procedure)

Brain-injured group

Experimental

干预措施: temperature obtained by the non-invasive method of zero-heat flux (Procedure)

Brain-injured group

Experimental

干预措施: esophageal temperature (Procedure)

Brain-injured group

Experimental

干预措施: intracerebral temperature (Procedure)

Hypothermia group

Experimental

干预措施: esophageal temperature (Procedure)

Hypothermia group

Experimental

干预措施: intracerebral temperature (Procedure)

Hypothermia group

Experimental

干预措施: temperature obtained by the non-invasive method of zero-heat flux (Procedure)

Hyperthermia group

Experimental

干预措施: temperature obtained by the non-invasive method of zero-heat flux (Procedure)

Hyperthermia group

Experimental

干预措施: esophageal temperature (Procedure)

Hyperthermia group

Experimental

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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