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Bilateral Bispectral Index (BIS) Study (BIS)

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ClinicalTrials.gov Identifier: NCT01187420
Recruitment Status : Completed
First Posted : August 24, 2010
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date March 31, 2010
First Posted Date August 24, 2010
Last Update Posted Date February 13, 2017
Study Start Date June 2009
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 23, 2010)
Detection of delayed cerebral ischemia (DCI) utilizing Bispectral Index (BIS) [ Time Frame: 10 days stay at the NSICU ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01187420 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 23, 2010)
BIS correlation with angiography and transcranial doppler flow for detection of cerebral vasospasm [ Time Frame: 10 days stay at the NSICU ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Bilateral Bispectral Index (BIS) Study
Official Title Real Time Monitoring for Cerebral Vasospasm Using Bilateral Processed Electroencephalogram (EEG)
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Neurosurgical ICU patients with Subarachnoid Hemorrhage
Condition
  • Cerebral Vasospasm
  • Delayed Cerebral Ischemia
  • Subarachnoid Hemorrhage
Intervention Not Provided
Study Groups/Cohorts EEG and Cerebral Vasospasm
Cerebral Vasospasm and role of BIS vista monitor in Subarachnoid Hemorrhage (SAH) patients
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 5, 2011)
30
Original Estimated Enrollment
 (submitted: August 23, 2010)
100
Actual Study Completion Date October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01187420
Other Study ID Numbers 09-0470
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Icahn School of Medicine at Mount Sinai
Study Sponsor Icahn School of Medicine at Mount Sinai
Collaborators Not Provided
Investigators
Principal Investigator: Stacie Deiner, MD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date February 2017