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临床试验/NCT03457090
NCT03457090Unknown不适用

Extracorporeal Membrane Oxygenation and Cerebral Blood Flow Velocity Evaluated by Transcranial Doppler

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年4月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Cerebral blood flow velocities evolution

研究概览

简要总结

To determine how venoarterial extracorporeal membrane oxygenation (ECMO) affects cerebral blood flow velocity (CBFV) measured by transcranial doppler (TCD), to determine whether specific changes in cerebral blood flow velocity may be associated with neurologic injury and to determine modifications of CBFV after withdrawal of ECMO.

详细描述

Venoarterial Extracorporeal membrane oxygenation (ECMO) is used in adult with refractory cardiac failure as a life-saving measure. Adults treated with ECMO survived to hospital discharge in 21,8% to 65,4% of cases. Neurologic complications such as intracranial hemorrhage, anoxia and ischemia are major causes of death and long-term disability in ECMO patients (7% to 14%). Current neurological monitoring techniques are insufficient to predict which critically ill patient receiving ECMO therapy will suffer from neurologic injury. Even after a clinical suspicion of neurologic injury, diagnosis can be difficult. TCD is commonly used to monitor the CBFV of traumatic brain injury. There are no reports that evaluate CBFV of patients requiring ECMO therapy. Patient will have to do both echocardiography and TCD to evaluate cardiac output and CBFV. We will repeat these dopplers every 24 hours until ECMO withdrawal and one day after explantation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

  • adult patient who receiving ECMO therapy

排除标准

  • cervico-encephalic vasculopathy
  • lacked an acoustic window allowing for adequate TCD examination
  • stroke in medical past.

研究组 & 干预措施

Patient treated with ECMO

Experimental

Patient treated with ECMO will have Examination : a TCD and Trans-Thoracic Echocardiography (TTE)

干预措施: Examination : a TCD and Trans-Thoracic Echocardiography (Other)

结局指标

主要结局

Cerebral blood flow velocities evolution

时间窗: 24 hours

Cerebral blood flow velocities evolution over the time

The correlation of Cerebral blood flow velocities with the variation of the cardiac output and ECMO flow.

时间窗: 24 hours

The correlation with the variation of the cardiac output and ECMO flow.

次要结局

  • Relation between acute neurologic injury and variation of CBFV(24 hours)
  • Modification of the CBFV detected by TCD after the withdrawal of the ECMO.(24 hours)
  • Relation between the CBFV, the NIRS, the cardiac flow and the ECMO flow.(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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