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Completed

NCT Number: NCT01187420

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

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

    Time frame: 10 days stay at the NSICU

Secondary outcomes

  1. BIS correlation with angiography and transcranial doppler flow for detection of cerebral vasospasm

    Time frame: 10 days stay at the NSICU

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Acronym: BIS

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 24, 2010
Registry last updated
Feb 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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