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临床试验/NCT03822026
NCT03822026已完成不适用

Effects of Moderate Hyperventilation on Cerebral Hemodynamics, Oxygenation and Metabolism in Patients With Severe Traumatic Brain Injury

University of Zurich1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2014年5月20日最近更新:
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
11
试验地点
1
主要终点
intracranial pressure

研究概览

简要总结

Elevated intracranial pressure is a dangerous and potentially fatal complication after traumatic brain injury. Hyperventilation is a medical intervention to reduce elevated intracranial pressure by inducing cerebral vasoconstriction, which might be associated to cerebral ischemia and hypoxia.

The main hypothesis is that a moderate degree of hyperventilation is sufficient to reduce the intracranial pressure without inducing cerebral ischemia.

详细描述

In patients with severe traumatic brain injury (TBI), and with intracranial pressure-monitoring, brain tissue oxygen tension and/or microdialysis probes hyperventilation-tests are performed in the acute phase after trauma. Data are collected and TCCD measurements are performed at baseline, at the beginning of moderate hyperventilation, after prolonged moderate hyperventilation (for 50 minutes) and after return to baseline.

The present study aims to quantify potential adverse effects of moderate short-term hyperventilation during the acute phase of the severe TBI on cerebral hemodynamics, oxygenation, and metabolism.

研究设计

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

  • •nonpenetrating traumatic brain injury
  • •Glasgow coma scale <9 at presentation
  • •Intracranial pressure monitoring
  • •brain tissue oxygen tension monitoring and/or microdialysis monitoring
  • •invasive mechanical ventilation with FIO2 <60% and PEEP <15 mbar

排除标准

  • •decompressive craniectomy
  • •pregnancy
  • •pre-existing neurological disease
  • •previous traumatic brain injury
  • •acute cardiovascular disease
  • •severe respiratory failure
  • •acute on chronic liver disease
  • •failure to obtain satisfactory bilateral TCCD signals
  • •persisting hypovolemia or hemodynamic instability

研究组 & 干预措施

patients with severe TBI

Other

Patients with severe TBI enrolled in the study undergo an hyperventilation test, in which the alveolar ventilation is increased by a stepwise increase in tidal volumes and respiratory rate until a reduction of etCO2 of 0.7 kPa is achieved.

干预措施: Hyperventilation test (Other)

结局指标

主要结局

intracranial pressure

时间窗: 10, 20, 50, 60 minutes after begin of the hyperventilation test

Change of intracranial pressure during moderate hyperventilation

次要结局

  • cerebral flow velocity in the middle cerebral artery(20, 50, 60 minutes after begin of the hyperventilation test)
  • brain tissue oxygenation (PbrO2)(10, 20, 50, 60 minutes after begin of the hyperventilation test)
  • cerebral Lactate/ Pyruvate ratio(1 hour before initiation of the hyperventilation test, and 1 and 2 hours after begin of the hyperventilation test)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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