Bilateral Bispectral Index (BIS) Study

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01187420
• Date of registration: 31/03/2010
• Primary sponsor: Mount Sinai School of Medicine
• Public title: Bilateral Bispectral Index (BIS) Study BIS
• Scientific title: Real Time Monitoring for Cerebral Vasospasm Using Bilateral Processed Electroencephalogram (EEG)
• Date of first enrolment: June 2009
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01187420
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective

Countries of recruitment

United States

Contacts

• Name: Stacie Deiner, MD
• Affiliation: Mount Sinai School of Medicine

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cerebral Vasospasm

Delayed Cerebral Ischemia

Subarachnoid Hemorrhage

Primary Outcome(s)

Detection of delayed cerebral ischemia (DCI) utilizing Bispectral Index (BIS) [Time Frame: 10 days stay at the NSICU]

Secondary Outcome(s)

BIS correlation with angiography and transcranial doppler flow for detection of cerebral vasospasm [Time Frame: 10 days stay at the NSICU]

Secondary ID(s)

09-0470

Source(s) of Monetary Support

Please refer to primary and secondary sponsors