跳至主要内容
临床试验/NCT05303363
NCT05303363招募中不适用

Monitoring of Cerebral Blood Flow in Patients on Extracorporeal Membrane Oxygenation

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
1
主要终点
Cerebral Blood Flow (CBF) velocity using Transcranial Doppler Ultrasound (cm/sec)

研究概览

简要总结

Venovenous extracorporeal membrane oxygenation (VV-ECMO) is a supportive therapy, indicated in case of severe, possibly reversible pulmonary failure, refractory to conventional therapies. Despite advances, morbidity and mortality remain high. Severe neurological complications can occur during ECMO, but their exact etiology is not well understood. It is hypothesized that fast correction of severe hypercapnia, a common indication for venovenous ECMO, may be detrimental for the brain. The supposed mechanism is that fast correction of hypercapnia may result in massive cerebral vasoconstriction and impaired cerebral blood flow (CBF). In this prospective, observational study the aim is to quantify change in CBF during routine initial correction of severe hypercapnia during VV-ECMO. Furthermore, the investigators will record any other hemodynamic changes during VV-ECMO. The hypothesis is that a larger decline in PaCO2 will result in a larger decline of CBF.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • in order to be eligible to participate in this study, a subject must meet all of the following criteria:
  • High suspicion of an indication for VV-ECMO;
  • Arterial line present to enable blood sampling;
  • Older than 18 years.

排除标准

  • Subjects will be excluded if the cerebral blood flow cannot be measured using the transcranial Doppler
  • VA-ECMO or ECPR;
  • No possibility for neuromonitoring measurements due to technical difficulties, e.g. post-craniotomy, unsuitable transcranial window;
  • No possibility for neuromonitoring measurements due to circumstantial difficulties, e.g. ECPR;
  • Contraindications for ECMO;
  • ECMO is initiated in another center.

结局指标

主要结局

Cerebral Blood Flow (CBF) velocity using Transcranial Doppler Ultrasound (cm/sec)

时间窗: Before,during and after start of VV-ECMO,consisting of:starting 1 hour in advance of ECMO initiation, continuing until a maximum of 1 hour after the last change in SGF. 24 hours after ECMO initiation another measurement of 30 minutes will be performed.

Change in CBF after correction of extracellular (arterial) pH during ECMO

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

A.P.J. Vlaar

Principal Investigator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (1)

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