Bilateral Bispectral Index (BIS) Study - Full Text View

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 Mount Sinai School of Medicine:

Primary Outcome Measures:

Detection of delayed cerebral ischemia (DCI) utilizing Bispectral Index (BIS) [ Time Frame: 10 days stay at the NSICU ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187420

Locations

United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029

Sponsors and Collaborators

Mount Sinai School of Medicine

Investigators

Principal Investigator:

Stacie Deiner, MD

Mount Sinai School of Medicine

More Information

Publications:

Cross DT 3rd, Tirschwell DL, Clark MA, Tuden D, Derdeyn CP, Moran CJ, Dacey RG Jr. Mortality rates after subarachnoid hemorrhage: variations according to hospital case volume in 18 states. J Neurosurg. 2003 Nov;99(5):810-7.

Broderick JP, Brott TG, Duldner JE, Tomsick T, Leach A. Initial and recurrent bleeding are the major causes of death following subarachnoid hemorrhage. Stroke. 1994 Jul;25(7):1342-7.

Sehba FA, Bederson JB. Mechanisms of acute brain injury after subarachnoid hemorrhage. Neurol Res. 2006 Jun;28(4):381-98. Review.

Heros RC, Zervas NT, Varsos V. Cerebral vasospasm after subarachnoid hemorrhage: an update. Ann Neurol. 1983 Dec;14(6):599-608.

Claassen J, Hirsch LJ, Kreiter KT, Du EY, Connolly ES, Emerson RG, Mayer SA. Quantitative continuous EEG for detecting delayed cerebral ischemia in patients with poor-grade subarachnoid hemorrhage. Clin Neurophysiol. 2004 Dec;115(12):2699-710.

Aaslid R, Huber P, Nornes H. Evaluation of cerebrovascular spasm with transcranial Doppler ultrasound. J Neurosurg. 1984 Jan;60(1):37-41.

Lysakowski C, Walder B, Costanza MC, Tramèr MR. Transcranial Doppler versus angiography in patients with vasospasm due to a ruptured cerebral aneurysm: A systematic review. Stroke. 2001 Oct;32(10):2292-8.

Claassen J, Bernardini GL, Kreiter K, Bates J, Du YE, Copeland D, Connolly ES, Mayer SA. Effect of cisternal and ventricular blood on risk of delayed cerebral ischemia after subarachnoid hemorrhage: the Fisher scale revisited. Stroke. 2001 Sep;32(9):2012-20.

Frontera JA, Fernandez A, Schmidt JM, Claassen J, Wartenberg KE, Badjatia N, Connolly ES, Mayer SA. Defining vasospasm after subarachnoid hemorrhage: what is the most clinically relevant definition? Stroke. 2009 Jun;40(6):1963-8. Epub 2009 Apr 9.

Rosenwasser RH, Armonda RA, Thomas JE, Benitez RP, Gannon PM, Harrop J. Therapeutic modalities for the management of cerebral vasospasm: timing of endovascular options. Neurosurgery. 1999 May;44(5):975-9; discussion 979-80.

Sen I, Puri GD, Bapuraj JR. Early detection of cerebral vasospasm during a neurointerventional procedure using the BIS. Anaesth Intensive Care. 2005 Oct;33(5):691-2. No abstract available.

Claassen J, Mayer SA, Hirsch LJ. Continuous EEG monitoring in patients with subarachnoid hemorrhage. J Clin Neurophysiol. 2005 Apr;22(2):92-8. Review.

Towle VL, Bolaños J, Suarez D, Tan K, Grzeszczuk R, Levin DN, Cakmur R, Frank SA, Spire JP. The spatial location of EEG electrodes: locating the best-fitting sphere relative to cortical anatomy. Electroencephalogr Clin Neurophysiol. 1993 Jan;86(1):1-6.

Vespa PM, Nuwer MR, Juhász C, Alexander M, Nenov V, Martin N, Becker DP. Early detection of vasospasm after acute subarachnoid hemorrhage using continuous EEG ICU monitoring. Electroencephalogr Clin Neurophysiol. 1997 Dec;103(6):607-15.

Labar DR, Fisch BJ, Pedley TA, Fink ME, Solomon RA. Quantitative EEG monitoring for patients with subarachnoid hemorrhage. Electroencephalogr Clin Neurophysiol. 1991 May;78(5):325-32.

Schultz A, Siedenberg M, Grouven U, Kneif T, Schultz B. Comparison of Narcotrend Index, Bispectral Index, spectral and entropy parameters during induction of propofol-remifentanil anaesthesia. J Clin Monit Comput. 2008 Apr;22(2):103-11. Epub 2008 Feb 21.

Responsible Party:	Stacie Deiner, MD, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:	NCT01187420 History of Changes
Other Study ID Numbers:	09-0470
Study First Received:	March 31, 2010
Last Updated:	July 5, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:

Cerebral vasospasm
delayed cerebral ischemia (DCI)
subarachnoid hemorrhage (SAH) patients

Additional relevant MeSH terms:

Cerebral Infarction
Brain Ischemia
Hemorrhage
Ischemia
Subarachnoid Hemorrhage
Vasospasm, Intracranial
Brain Infarction
Cerebrovascular Disorders

Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Intracranial Hemorrhages

ClinicalTrials.gov processed this record on May 21, 2013