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Clinical Trials/NCT01187420
NCT01187420
Completed
Not Applicable

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

Icahn School of Medicine at Mount Sinai1 site in 1 country30 target enrollmentJune 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Vasospasm
Sponsor
Icahn School of Medicine at Mount Sinai
Enrollment
30
Locations
1
Primary Endpoint
Detection of delayed cerebral ischemia (DCI) utilizing Bispectral Index (BIS)
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
October 2010
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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)

Outcomes

Primary Outcomes

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

Time Frame: 10 days stay at the NSICU

Secondary Outcomes

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

Study Sites (1)

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