EEG, Cerebral Oximetry, and Arterial to Jugular Venous Lactate to Assess Cerebral Ischemia During Carotid Endarterectomy
|Internal Carotid Artery Stenosis||Device: EEGo, BIS, FORE-SIGHT cerebral oximeter|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Official Title:||A Comparison of the EEGo Monitor, BIS Monitor, and FORE-SIGHT Cerebral Oximeter With Arterial to Jugular Venous Lactate Difference to Assess Cerebral Ischemia During Carotid Endarterectomy|
- An assessment of the ability of the nonlinear EEG monitor (EEGo), the BIS monitor and the FORE-SIGHT cerebral oximeter to detect cerebral ischemia [ Time Frame: During cross-clamping of the carotid artery for carotid endarterectomy ]
- To determine the correlation of ischemic changes (if present) with SSEPs and EEG and arterial-jugular venous lactate differences [ Time Frame: During carotid endarterectomy ]
|Study Start Date:||September 2008|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Active Comparator: 1
All patients will have continuous EEGo, BIS and FORE-SIGHT monitoring, which will be correlated with arterial to jugular venous lactate differences.
Device: EEGo, BIS, FORE-SIGHT cerebral oximeter
The EEGo monitor, BIS monitor, and FORE-SIGHT cerebral oximeter will be used for cerebral monitoring of all patients. A comparison of the three monitors will be done. For EEGo monitoring, five bipolar electrodes will be placed per International 1020 system. For BIS monitoring, the BIS quattro sensor will be placed on the forehead in usual fashion. For FORE-SIGHT monitoring, the two sensor strips will be placed on the forehead in usual fashion.
All patients will have their ipsilateral Internal Jugular vein cannulated by the surgeon intraoperatively with a 16g IV cannula, through which a Portex multi-orifice epidural catheter will then be placed.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00737334
|Health Sciences Centre|
|Winnipeg, Manitoba, Canada, R3A 1R9|
|Principal Investigator:||W. Alan C. Mutch, MD||University of Manitoba|