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.
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
- Type of treatment
- Injection or infusion, Medical device
- 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.
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.
- Conditions
- Internal Carotid Artery Stenosis
- 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 group | Role | What they receive |
|---|---|---|
| 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. 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.
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)
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.
- First posted19 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Internal Carotid Artery StenosisStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Investigators
- W. Alan C. Mutch, MD, Principal investigator, University of Manitoba
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00737334
- Acronym / sponsor ID
- B2008:095
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 19 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: EEGo, BIS, FORE-SIGHT cerebral oximeterAll patients will have continuous EEGo, BIS and FORE-SIGHT monitoring, which will be correlated with arterial to jugular venous lactate differences. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients undergoing carotid endarterectomy will be approached in the Pre-Anesthetic Clinic
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEGo, BIS, FORE-SIGHT cerebral oximeterAlso: BIS Vista monitor with BIS Quattro sensor, FORE-SIGHT cerebral oximeterThe 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. | Device | 1 |
Primary outcome
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
1 secondary outcome
To determine the correlation of ischemic changes (if present) with SSEPs and EEG and arterial-jugular venous lactate differences
Time frame: During carotid endarterectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2009.
- Derived from this study: PubMed 20661680Espenell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W. Alan C. Mutch, MD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
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.