EEG, Cerebral Oximetry, and Arterial to Jugular Venous Lactate to Assess Cerebral Ischemia During Carotid Endarterectomy
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|ClinicalTrials.gov Identifier: NCT00737334|
Recruitment Status : Completed
First Posted : August 19, 2008
Last Update Posted : November 11, 2009
|Condition or disease||Intervention/treatment||Phase|
|Internal Carotid Artery Stenosis||Device: EEGo, BIS, FORE-SIGHT cerebral oximeter||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
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.
- 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 ]
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): NCT00737334
|Health Sciences Centre|
|Winnipeg, Manitoba, Canada, R3A 1R9|
|Principal Investigator:||W. Alan C. Mutch, MD||University of Manitoba|