AzTrials
AzTrials

Internal Carotid Artery StenosisNCT00737334

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

A study testing EEGo, BIS, FORE-SIGHT cerebral oximeter in people with Internal Carotid Artery Stenosis, run by University of Manitoba at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Internal Carotid Artery Stenosis
What is being tested?
EEGo, BIS, FORE-SIGHT cerebral oximeter
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCanada
Study dates
Sep 2008to Oct 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Health Sciences Centre

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

About this study

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

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.

Read the detailed description

Objective: This study is designed to test the hypothesis that the EEGo monitor will be superior to the BIS monitor to assess onset of cerebral ischemia if it should arise during CEA. The two EEG monitors will be compared with the FORE-SIGHT cerebral oximeter, and all three monitors will be correlated with arterial to jugular venous lactate differences before, during and after carotid cross-clamping.

We hypothesize that the EEGo monitor will be able to more accurately indicate if the brain is at risk of ischemia and better able to direct therapy to relieve the ischemic episode as compared to the BIS monitor. The EEGo will be superior because the raw signal is processed using phase delay analysis, with each patient's raw EEG analyzed instead of a proprietary but generic signal processing approach on a linear scale as with the BIS monitor. Phase delay analysis is a standard approach to display nonlinear signals. A highly reproducible signal transition occurs with differing depths of anesthesia. The ability to process the EEG and display phase delay plots in 50 msec is what makes the EEGo monitor attractive to acutely assess changes in the EEG which can manifest with cerebral ischemia. We also hypothesize that the FORE-SIGHT cerebral oximeter will be an effective monitor for detecting cerebral ischemia during CEA. Accurate assessment of changes in the EEG and cerebral tissue oxygen saturation with carotid cross-clamping will allow better anesthesia management of patients undergoing CEA.

This pilot study will be done to assess the ability of the nonlinear EEG monitor (the EEGo) compared to the BIS monitor and the FORE-SIGHT cerebral oximeter to direct therapy if cerebral ischemia occurs -- notifying the surgeon of the findings, optimizing the blood pressure, arterial oxygenation and carbon dioxide tensions, and permitting consideration of placing a carotid shunt. The EEGo processes the standard EEG signal by nonlinear analysis of the raw signal by 3 dimensional phase delay plots. A cascade from a point attractor, periodic attractor, toroidal attractor to a 3D chaotic attractor occurs from burst suppression to the awake state. These resemble phase transitions and occur rapidly from one state to the next. An analogy is the phase transition that occurs when water changes to ice and vice versa. Monitoring these transitions should permit a rational approach to monitoring cerebral well-being during carotid cross-clamping with CEA. The EEGo will be compared directly in real time to the bispectral (BIS) monitor and to the FORE-SIGHT cerebral oximeter for intraoperative monitoring during CEA.

Cerebral oximetry (also known as Near Infrared Spectroscopy or NIRS) provides a non-invasive measure of regional cerebral tissue oxygen saturation which reflects local oxygen supply and demand, and could indicate cerebral ischemia when desaturation occurs. The FORE-SIGHT cerebral oximeter is a non-invasive, optically-based near-infrared spectrometer that continuously estimates absolute cerebral tissue oxygen saturation, and works based on the principal that hemoglobin's two forms -- oxygenated and deoxygenated -- absorb light differently. The sensor projects laser into the brain at four different wavelengths (to maximize accuracy), with the reflected light being analyzed via algorithm to an absolute value of cerebral saturation. The FORE-SIGHT has been validated in several studies that have shown good precision of the cerebral tissue oxygen saturation value.

In addition, as previously stated, the two EEG monitors and FORE-SIGHT cerebral oximeter will be correlated with arterial to jugular venous lactate differences. In a recent paper, arterial to jugular venous lactate differences were shown to be especially sensitive for detecting cerebral ischemia in awake surgery for CEA. In that paper the sensitivity of lactate differences to detect ischemic changes was 100% for a difference greater than 0.1 mmole/L; 100% specificity if the difference exceeded 0.32 mmole/L; and an ROC best fit for a difference greater than 0.16 mmole/L. In this study we plan to look at a combined approach during carotid artery cross-clamping -- measures of lactate differences with simultaneous assessment of cerebral tissue oxygen saturation using the FORE-SIGHT cerebral oximeter, and EEG changes using two different processed EEG monitors (the well established BIS monitor and the newer EEGo monitor). As such, this is intensified monitoring for these patients at risk of cerebral ischemia over the standard of care.

Being tested
EEGo, BIS, FORE-SIGHT cerebral oximeter
Keywords
Carotid stenosis, EEGo, nonlinear EEG, BIS, cerebral oximetry, FORE-SIGHT cerebral oximeter, cerebral monitoring, arterial jugular venous lactate difference, cerebral ischemia, carotid endarterectomy
Medical subject headings
Carotid Stenosis, Brain Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EEGo, BIS, FORE-SIGHT cerebral oximeterDevice

    Also called BIS Vista monitor with BIS Quattro sensor, 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.

Study groups in NCT00737334
Study groupRoleWhat they receive
1Active comparatorAll patients will have continuous EEGo, BIS and FORE-SIGHT monitoring, which will be correlated with arterial to jugular venous lactate differences.
Receives: Device: EEGo, BIS, FORE-SIGHT cerebral oximeter

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: During cross-clamping of the carotid artery for carotid endarterectomy

Secondary outcomes (1)
  1. To determine the correlation of ischemic changes (if present) with SSEPs and EEG and arterial-jugular venous lactate differences

    Measured: During carotid endarterectomy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionOct 2009
  4. Study completionOct 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00737334
Sponsor's protocol ID
B2008:095
Status last verified
Nov 2009
First submitted
15 Aug 2008
Last updated
11 Nov 2009
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20661680

Questions about this trial

What is this clinical trial studying?

A study testing EEGo, BIS, FORE-SIGHT cerebral oximeter in people with Internal Carotid Artery Stenosis, run by University of Manitoba at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00737334, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2009.

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