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临床试验/NCT04687605
NCT04687605已完成不适用

Therapeutic Hypercapnia After Aneurysmal Subarachnoid Hemorrhage - Study for the Optimum Duration of Hypercapnia

University of Wuerzburg0 个研究点目标入组 12 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
主要终点
Cerebral blood flow (CBF)

研究概览

简要总结

Temporary hypercapnia leads to a reproducible increase of cerebral blood flow (CBF) and brain tissue oxygenation (StiO2) as shown in a previous study (Trial-Identification: NCT01799525). The aim of this study now was to measure the course of carbon dioxide partial pressure (pCO2) reactivity after prolonged hypercapnia, and to evaluate the therapeutic effect of graded hypercapnia.

详细描述

Cerebral vasospasm still is the leading cause of delayed cerebral ischemia (DCI) and secondary ischemic deficits after aneurysmal subarachnoid hemorrhage (SAH). Hypercapnia leads to a reproducible increase of cerebral blood flow (CBF) and brain tissue oxygenation (StiO2) as shown in a previous study (Trial-Identification: NCT01799525). Furthermore, the increase of CBF and StiO2 sustained after normalization of ventilation and no rebound effect was found. So, a possible optimization of the hypercapnic period may lead to prolonged effects of increased CBF and StiO2. Aim of this stuy is to find the ideal duration of hypercapnia and to evaluate the therapeutic effect of graded hypercapnia. For this, intubated and mechanically ventilated patients with an aneurysmal SAH Hunt/Hess 3-5, Fisher grade 2-4 on the initial CT scan and supplied with an external ventricular drainage will be included within the first 96 hours after ictus. Between day 4 and 14 they undergo a trial intervention in which the respiratory minute volume will be reduced in order to maintain a target PaCO2 of 50 - 55 mmHg for 2 hours. Arterial blood gas analysis (ABG) and transcranial Doppler sonography (TCD) is performed in 15-minute intervals. Intracranial pressure (ICP), cerebral perfusion pressure (CPP), and cardiovascular parameters are monitored continuously, serial measurement of CBF and StiO2 under continous hypercapnia is performed. Primary endpoint of this trial is change of CBF under hypercapnia, secondary endpoints are StiO2, measures non-invasively with near-infrared spectroscopy, mean flow velocity of intracranial vessels in TCD, delayed cerebral infarction in cranial CT and Glasgow Outcome Score (GOS) after 6 months.

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

入选标准

  • Aneurysmal SAH
  • Aneurysm occluded by clipping/coiling within 96 hours
  • Hunt/Hess 3-5
  • Fisher 2-4 on initial CT scan
  • Intubated, sedated and mechanically ventilated patient
  • Continous drainage of cerebrospinal fluid (CSF)

排除标准

  • Age under 18 years
  • Pregnancy
  • Common obstructive lung disease (COLD)
  • potential of hydrogen (pH) in ABG < 7,25
  • ICP > 20 mmHg

结局指标

主要结局

Cerebral blood flow (CBF)

时间窗: 2-4 hours, day 4-14 after SAH

Changes of CBF (absolute, ml/100g tissue/min) under changes of arterial pCO2

次要结局

  • Cerebral tissue oxygen saturation(2-4 hours, day 4-14 after SAH)
  • Glasgow Outcome Score (GOS)(up to 6 months)

研究者

发起方
University of Wuerzburg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Stetter

Principial Investigator

University of Wuerzburg

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