Bilateral Bispectral Index (BIS) Study
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.
Delayed Cerebral Ischemia
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Real Time Monitoring for Cerebral Vasospasm Using Bilateral Processed Electroencephalogram (EEG)|
- Detection of delayed cerebral ischemia (DCI) utilizing Bispectral Index (BIS) [ Time Frame: 10 days stay at the NSICU ] [ Designated as safety issue: No ]
- BIS correlation with angiography and transcranial doppler flow for detection of cerebral vasospasm [ Time Frame: 10 days stay at the NSICU ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
EEG and Cerebral Vasospasm
Cerebral Vasospasm and role of BIS vista monitor in Subarachnoid Hemorrhage (SAH) patients
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01187420
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Principal Investigator:||Stacie Deiner, MD||Mount Sinai School of Medicine|