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EEG, Cerebral Oximetry, and Arterial to Jugular Venous Lactate to Assess Cerebral Ischemia During Carotid Endarterectomy

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. Identifier: NCT00737334
Recruitment Status : Completed
First Posted : August 19, 2008
Last Update Posted : November 11, 2009
Information provided by:
University of Manitoba

Brief Summary:
A highly desired result during carotid endarterectomy (CEA) is the ability to predict and warn the surgeon if the brain is at risk of damage during the period of time that the carotid artery is cross-clamped for surgical repair of the vessel narrowing. A number of approaches for cerebral monitoring have been developed, including EEG, cerebral oximetry, and measurement of arterial to jugular venous concentration differences of oxygen, glucose or lactate. This study will utilize and compare multiple monitoring approaches for detecting when and if the brain is at risk of injury during CEA. As such, this robust approach to monitoring may permit a more prompt intervention to prevent or limit damage should cerebral ischemia occur. In this study we will compare a processed EEG monitor -- the EEGo, which uses nonlinear analysis to a bispectral (BIS) index monitor, and to the FORE-SIGHT cerebral oximeter to assess the ability of each to identify cerebral ischemia should it occur with carotid artery cross-clamping during CEA. These monitors will be correlated with arterial to jugular venous lactate concentration difference, which has recently been shown to be a sensitive indicator of hemispheric ischemia during CEA.

Condition or disease Intervention/treatment Phase
Internal Carotid Artery Stenosis Device: EEGo, BIS, FORE-SIGHT cerebral oximeter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
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
Study Start Date : September 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Arm Intervention/treatment
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.

Other Names:
  • BIS Vista monitor with BIS Quattro sensor
  • FORE-SIGHT cerebral oximeter

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To determine the correlation of ischemic changes (if present) with SSEPs and EEG and arterial-jugular venous lactate differences [ Time Frame: During carotid endarterectomy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All adult patients undergoing carotid endarterectomy will be approached in the Pre-Anesthetic Clinic

Exclusion Criteria:

  • Patient refusal
  • A history of asthma requiring routine use of bronchodilators because the study will use desflurane as the volatile agent
  • Pregnancy
  • Non-elective carotid endarterectomy

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 identifier (NCT number): NCT00737334

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Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Sponsors and Collaborators
University of Manitoba
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Principal Investigator: W. Alan C. Mutch, MD University of Manitoba
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: W. Alan C. Mutch MD, University of Manitoba Identifier: NCT00737334    
Other Study ID Numbers: B2008:095
First Posted: August 19, 2008    Key Record Dates
Last Update Posted: November 11, 2009
Last Verified: November 2009
Keywords provided by University of Manitoba:
Carotid stenosis
nonlinear EEG
cerebral oximetry
FORE-SIGHT cerebral oximeter
cerebral monitoring
arterial jugular venous lactate difference
cerebral ischemia
carotid endarterectomy
Additional relevant MeSH terms:
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Brain Ischemia
Cerebral Infarction
Carotid Stenosis
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Carotid Artery Diseases
Arterial Occlusive Diseases