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

This study has been completed.
Sponsor:
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00737334
First received: August 15, 2008
Last updated: November 9, 2009
Last verified: November 2009
  Purpose

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 Intervention
Internal Carotid Artery Stenosis
Device: EEGo, BIS, FORE-SIGHT cerebral oximeter

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the correlation of ischemic changes (if present) with SSEPs and EEG and arterial-jugular venous lactate differences [ Time Frame: During carotid endarterectomy ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737334

Locations
Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: W. Alan C. Mutch, MD University of Manitoba
  More Information

No publications provided

Responsible Party: W. Alan C. Mutch MD, University of Manitoba
ClinicalTrials.gov Identifier: NCT00737334     History of Changes
Other Study ID Numbers: B2008:095
Study First Received: August 15, 2008
Last Updated: November 9, 2009
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
Carotid stenosis
EEGo
nonlinear EEG
BIS
cerebral oximetry
FORE-SIGHT cerebral oximeter
cerebral monitoring
arterial jugular venous lactate difference
cerebral ischemia
carotid endarterectomy

Additional relevant MeSH terms:
Carotid Stenosis
Cerebral Infarction
Brain Ischemia
Constriction, Pathologic
Ischemia
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Stroke
Pathological Conditions, Anatomical
Pathologic Processes

ClinicalTrials.gov processed this record on August 18, 2014