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

NCT00737334 | Completed

• 1 other identifier: B2008:095
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Internal Carotid Artery Stenosis

Keywords

Carotid stenosis; EEGo; nonlinear EEG; BIS; cerebral oximetry; FORE-SIGHT cerebral oximeter; cerebral monitoring; arterial jugular venous lactate difference; cerebral ischemia; carotid endarterectomy

Outcome Measures

Primary Outcomes (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

  During cross-clamping of the carotid artery for carotid endarterectomy

Secondary Outcomes (1)

• To determine the correlation of ischemic changes (if present) with SSEPs and EEG and arterial-jugular venous lactate differences

  During carotid endarterectomy

Study Arms (1)

1

ACTIVE COMPARATOR

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

Interventions

EEGo, BIS, FORE-SIGHT cerebral oximeter DEVICE

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.

Also known as: BIS Vista monitor with BIS Quattro sensor, FORE-SIGHT cerebral oximeter

1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Related Publications (1)

• Espenell AE, McIntyre IW, Gulati H, Girling LG, Wilkinson MF, Silvaggio JA, Koulack J, West M, Harding GE, Kaufmann AM, Mutch WA. Lactate flux during carotid endarterectomy under general anesthesia: correlation with various point-of-care monitors. Can J Anaesth. 2010 Oct;57(10):903-12. doi: 10.1007/s12630-010-9356-7. Epub 2010 Jul 27.

  PMID: 20661680 DERIVED

MeSH Terms

Conditions

Carotid Stenosis; Brain Ischemia

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• W. Alan C. Mutch, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 15, 2008
• First Posted: August 19, 2008
• Study Start: September 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: November 11, 2009

Record last verified: 2009-11

Locations

CA (1)