跳至主要内容
临床试验/NCT01187420
NCT01187420已完成不适用

Real Time Monitoring for Cerebral Vasospasm Using Bilateral Processed Electroencephalogram (EEG)

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Detection of delayed cerebral ischemia (DCI) utilizing Bispectral Index (BIS)

研究概览

简要总结

The purpose of this study is to assess real time changes in raw and processed EEG in relation to the clinical and radiological evidence of cerebral vasospasm.

详细描述

Subarachnoid hemorrhage (SAH) is a prevalent and morbid condition (45%-30 day mortality). One of the major causes of reduced cerebral blood flow (CBF) after initial SAH is cerebral vasospasm. Early treatment of cerebral vasospasm (< 2 hr) is necessary for improved neurologic outcome. Hence, there is significant interest in development of a monitor. The most common bedside diagnostic tool is Transcranial Doppler (TCD) which is controversial given its low sensitivity and specificity. TCD is not a continuous monitor and is user dependent. Many centers rely on Cerebral Angiography for diagnosis of vasospasm; however angiographic spasm does not correlate with outcome. EEG can detect changes in cerebral blood flow which precede clinical decline but is technically difficult to perform and not practical for continuous monitoring.

Processed EEG monitors have become somewhat popular in the operating setting for assessment of depth of anesthesia. The recent introduction of bilateral 4 channel disposable probes presents to opportunity to use EEG as a non-invasive continuous monitor for vasospasm. We propose a prospective observational study to assess real time changes in raw and processed EEG which we will correlate with clinical and radiologic evidence of vasospasm. Our primary clinical endpoint will be the determination of delayed cerebral ischemia. This modality could prove to be a significant clinical advantage for patients suffering from SAH.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult men or women of any age and ethnicity within 48 hours of subarachnoid hemorrhage (SAH)

排除标准

  • Age < 18 years
  • Greater than 48 hours past the initial hemorrhage
  • Previous history of stroke of any etiology
  • Inability to consent for themselves or have a proxy to consent for them (implied consent)

结局指标

主要结局

Detection of delayed cerebral ischemia (DCI) utilizing Bispectral Index (BIS)

时间窗: 10 days stay at the NSICU

次要结局

  • BIS correlation with angiography and transcranial doppler flow for detection of cerebral vasospasm(10 days stay at the NSICU)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验