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Bilateral Bispectral Index (BIS) Study (BIS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01187420
First Posted: August 24, 2010
Last Update Posted: February 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
  Purpose
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.

Condition
Cerebral Vasospasm Delayed Cerebral Ischemia Subarachnoid Hemorrhage

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real Time Monitoring for Cerebral Vasospasm Using Bilateral Processed Electroencephalogram (EEG)

Further study details as provided by Icahn School of Medicine at Mount Sinai:

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

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

Enrollment: 30
Study Start Date: June 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
EEG and Cerebral Vasospasm
Cerebral Vasospasm and role of BIS vista monitor in Subarachnoid Hemorrhage (SAH) patients

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neurosurgical ICU patients with Subarachnoid Hemorrhage
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187420


Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Stacie Deiner, MD Icahn School of Medicine at Mount Sinai
  More Information

Publications:

Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01187420     History of Changes
Other Study ID Numbers: 09-0470
First Submitted: March 31, 2010
First Posted: August 24, 2010
Last Update Posted: February 13, 2017
Last Verified: February 2017

Keywords provided by Icahn School of Medicine at Mount Sinai:
Cerebral vasospasm
delayed cerebral ischemia (DCI)
subarachnoid hemorrhage (SAH) patients

Additional relevant MeSH terms:
Hemorrhage
Ischemia
Subarachnoid Hemorrhage
Brain Ischemia
Cerebral Infarction
Vasospasm, Intracranial
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Stroke