Carotid EndarterectomyNCT05267782
Correlation Between New O3 Regional Oximetry, Electroencephalography and the Somatosensory Evoked Potential in Carotid Endarterectomy Surgery
An observational study of Carotid Endarterectomy, run by Cleveland Clinic Abu Dhabi at 1 site in United Arab Emirates.
Trial summary
Carotid endarterectomy (CEA) is one of the modalities to treat carotid artery disease. One of the perioperative complications of this surgery includes stroke, a condition that occurs when the blood supply to part of your brain is interrupted or reduced. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Endarterectomy
- What is being tested?
- Masimo's O3 Regional Oximetry
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Apr 2022to 17 Feb 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is prospective observational pilot study and only 10 subjects will be recruited after application of the below inclusion/exclusion criteria. Subjects will be included only if they sign informed consent for study. The anticipated duration of subject's participation in this study will not exceed duration of surgery.
Who may be able to join
- Subjects older than 18 years of age
- Subjects undergoing carotid endarterectomy.
- American Society of Anaesthesiologists Classification (ASA) score I to III.
Who cannot join
- American Society of Anaesthesiologists Classification (ASA) score IV and V.
- Subject has skin abnormalities affecting the sensor placement
- Emergency cases
- Cognitive/Mentally impaired or unable to provide consent
- Pregnant subject
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Cleveland Clinic Abu Dhabi
Abu Dhabi, Abu Dhabi Emirate, 0000
About this study
Carotid endarterectomy (CEA) is one of the modalities to treat carotid artery disease. One of the perioperative complications of this surgery includes stroke, a condition that occurs when the blood supply to part of your brain is interrupted or reduced. To prevent cerebral ischemia during carotid endarterectomy several methods have been employed in clinical practice, such as awake neurocognitive assessment, electroencephalography, evoked potentials, transcranial Doppler, carotid stump pressure, and near infrared spectroscopy (Regional Oximetry).
Meta-analysis published by Nwachuku EL and colleagues suggests that intraoperative somatosensory evoked potential (SSEP) is a highly specific test in predicting neurological outcome following CEA. Sridharan and colleagues advise multimodality in intraoperative monitoring, with simultaneous use of EEG and SSEP which will improve the diagnostic accuracy. Use of regional oximetry as a continuous, real time and non-invasive monitoring, during CEA is controversial, with pros and cons studies that do not contribute to a clear picture of its application in everyday clinical practice.
Read more
Masimo's O3 Regional Oximetry is new monitoring approved in 2020 by FDA for monitoring somatic tissue oxygenation saturation in all patient populations and for monitoring relative changes in haemoglobin, oxyhaemoglobin, and deoxyhaemoglobin in adult brains. This monitoring can help clinicians to monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain. One such example is carotid endarterectomy (CEA).
Masimo's O3 regional oximetry is integrated part of the SedLine® Brain Function Monitoring (Masimo, Irvine, California, USA, 1989) on the Root® Patient Monitoring Platform. Sensors are equipped within Masimo Open Connect (MOC-9) modules which are applied to the patient's forehead and connected to the Masimo Root® patient monitoring and connectivity platform.
Masimo's O3 Regional Oximetry provides regional or tissue haemoglobin oxygen saturation and unlike peripheral pulse oximetry, which reflects the body's general arterial blood oxygenation, O3 provides information about the local tissue's haemoglobin oxygen saturation, both in cerebral and somatic applications. This information provides additional insight that may help inform clinicians of changes in cerebral or somatic tissue oxygen levels.
Regional Oximetry is already part of the standard monitoring used during CEA in Cleveland Clinic Abu Dhabi, together with electroencephalography and the somatosensory evoked potentials.
Using new Masimo's O3 regional oximetry monitoring (same sensor, only the module is new with new parameters) we will have additional parameters that have not been analysed before:
- Δbase
- ΔSpO2
- ΔcHbi
- Δ HHbi
- ΔO2Hbi
With this in mind, the authors would like to analyse the correlation between new Masimo's O3 regional oximetry parameters, EEG and SSEP in CEA.
- Conditions
- Carotid Endarterectomy
- Being tested
- Masimo's O3 Regional Oximetry
- Keywords
- O3 regional oximetry, somatosensory evoked potential, electroencephalography, carotid endarterectomy surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo's O3 Regional OximetryDevice
Correlation between new O3 regional oximetry monitoring, electroencephalography and somatosensory evoked potential in carotid endarterectomy and data collection during different stages of anaesthesia and correlation with new O3 regional oximetry
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between new O3 regional oximetry monitoring, electroencephalography and SSEP in CEA.
Measured: The anticipated duration will not exceed duration of surgery.
Secondary outcomes (1)
Data collection during different stages of anaesthesia and correlation with new O3 regional oximetry
Measured: The anticipated duration will not exceed duration of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start1 Apr 2022
- Primary completion17 Feb 2025
- Study completion17 Feb 2025
Why it stopped: Due to the change in the surgical approach, it is not possible to recruit future patients. Future patients will have this type of surgical intervention by a vascular surgeon, where EEG and SSEP are not applied during the surgery.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Carotid EndarterectomyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cleveland Clinic Abu Dhabi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boris Tufegdzic, Cleveland Clinic Abu Dhabi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267782
- Sponsor's protocol ID
- A-2022-005
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2022
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nwachuku EL, Balzer JR, Yabes JG, Habeych ME, Crammond DJ, Thirumala PD. Diagnostic value of somatosensory evoked potential changes during carotid endarterectomy: a systematic review and meta-analysis. JAMA Neurol. 2015 Jan;72(1):73-80. doi: 10.1001/jamaneurol.2014.3071.
PubMed 25383418Domenick Sridharan N, Thirumala P, Chaer R, Balzer J, Long B, Crammond D, Makaroun M, Avgerinos E. Predictors of cross-clamp-induced intraoperative monitoring changes during carotid endarterectomy using both electroencephalography and somatosensory evoked potentials. J Vasc Surg. 2018 Jan;67(1):191-198. doi: 10.1016/j.jvs.2017.04.064. Epub 2017 Jul 5.
PubMed 28688529Friedell ML, Clark JM, Graham DA, Isley MR, Zhang XF. Cerebral oximetry does not correlate with electroencephalography and somatosensory evoked potentials in determining the need for shunting during carotid endarterectomy. J Vasc Surg. 2008 Sep;48(3):601-6. doi: 10.1016/j.jvs.2008.04.065. Epub 2008 Jul 18.
PubMed 18639412Tan TW, Garcia-Toca M, Marcaccio EJ Jr, Carney WI Jr, Machan JT, Slaiby JM. Predictors of shunt during carotid endarterectomy with routine electroencephalography monitoring. J Vasc Surg. 2009 Jun;49(6):1374-8. doi: 10.1016/j.jvs.2009.02.206.
PubMed 19497494https://www.masimo.com/technology/brain-monitoring/cerebral-oximetry
https://www.masimo.com/siteassets/us/documents/pdf/plm_11661c_brochure_o3_series_us.pdf
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between New O3 Regional Oximetry, Electroencephalography and the Somatosensory Evoked Potential in Carotid Endarterectomy Surgery
- ClinicalTrials.gov ID
- NCT05267782
- Acronym / sponsor ID
- A-2022-005
- Conditions
- Carotid Endarterectomy
- Keywords
- O3 regional oximetry, somatosensory evoked potential, electroencephalography, carotid endarterectomy surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to the change in the surgical approach, it is not possible to recruit future patients. Future patients will have this type of surgical intervention by a vascular surgeon, where EEG and SSEP are not applied during the surgery.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Cleveland Clinic Abu DhabiUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 4 Mar 2022 (actual)
- 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.
Carotid endarterectomy (CEA) is one of the modalities to treat carotid artery disease. One of the perioperative complications of this surgery includes stroke, a condition that occurs when the blood supply to part of your brain is interrupted or reduced. To prevent cerebral ischemia during carotid endarterectomy several methods have been employed in clinical practice, such as awake neurocognitive assessment, electroencephalography, evoked potentials, transcranial Doppler, carotid stump pressure, and near infrared spectroscopy (Regional Oximetry).
Meta-analysis published by Nwachuku EL and colleagues suggests that intraoperative somatosensory evoked potential (SSEP) is a highly specific test in predicting neurological outcome following CEA. Sridharan and colleagues advise multimodality in intraoperative monitoring, with simultaneous use of EEG and SSEP which will improve the diagnostic accuracy. Use of regional oximetry as a continuous, real time and non-invasive monitoring, during CEA is controversial, with pros and cons studies that do not contribute to a clear picture of its application in everyday clinical practice.
Masimo's O3 Regional Oximetry is new monitoring approved in 2020 by FDA for monitoring somatic tissue oxygenation saturation in all patient populations and for monitoring relative changes in haemoglobin, oxyhaemoglobin, and deoxyhaemoglobin in adult brains. This monitoring can help clinicians to monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain. One such example is carotid endarterectomy (CEA).
Masimo's O3 regional oximetry is integrated part of the SedLine® Brain Function Monitoring (Masimo, Irvine, California, USA, 1989) on the Root® Patient Monitoring Platform. Sensors are equipped within Masimo Open Connect (MOC-9) modules which are applied to the patient's forehead and connected to the Masimo Root® patient monitoring and connectivity platform.
Masimo's O3 Regional Oximetry provides regional or tissue haemoglobin oxygen saturation and unlike peripheral pulse oximetry, which reflects the body's general arterial blood oxygenation, O3 provides information about the local tissue's haemoglobin oxygen saturation, both in cerebral and somatic applications. This information provides additional insight that may help inform clinicians of changes in cerebral or somatic tissue oxygen levels.
Regional Oximetry is already part of the standard monitoring used during CEA in Cleveland Clinic Abu Dhabi, together with electroencephalography and the somatosensory evoked potentials.
Using new Masimo's O3 regional oximetry monitoring (same sensor, only the module is new with new parameters) we will have additional parameters that have not been analysed before:
- Δbase
- ΔSpO2
- ΔcHbi
- Δ HHbi
- ΔO2Hbi
With this in mind, the authors would like to analyse the correlation between new Masimo's O3 regional oximetry parameters, EEG and SSEP in CEA.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is prospective observational pilot study and only 10 subjects will be recruited after application of the below inclusion/exclusion criteria. Subjects will be included only if they sign informed consent for study. The anticipated duration of subject's participation in this study will not exceed duration of surgery.
Key inclusion criteria (3 listed)
- Subjects older than 18 years of age
- Subjects undergoing carotid endarterectomy.
- American Society of Anaesthesiologists Classification (ASA) score I to III.
Key exclusion criteria (5 listed)
- American Society of Anaesthesiologists Classification (ASA) score IV and V.
- Subject has skin abnormalities affecting the sensor placement
- Emergency cases
- Cognitive/Mentally impaired or unable to provide consent
- Pregnant subject
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 |
|---|---|---|
| Masimo's O3 Regional OximetryCorrelation between new O3 regional oximetry monitoring, electroencephalography and somatosensory evoked potential in carotid endarterectomy and data collection during different stages of anaesthesia and correlation with new O3 regional oximetry | Device | – |
Primary outcome
Correlation between new O3 regional oximetry monitoring, electroencephalography and SSEP in CEA.
Time frame: The anticipated duration will not exceed duration of surgery.
1 secondary outcome
Data collection during different stages of anaesthesia and correlation with new O3 regional oximetry
Time frame: The anticipated duration will not exceed duration of surgery.
Results and safety
The study was stopped early (reason given: Due to the change in the surgical approach, it is not possible to recruit future patients. Future patients will have this type of surgical intervention by a vascular surgeon, where EEG and SSEP are not applied during the surgery.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 25383418Nwachuku EL, Balzer JR, Yabes JG, Habeych ME, Crammond DJ, Thirumala PD. Diagnostic value of somatosensory evoked potential changes during carotid endarterectomy: a systematic review and meta-analysis. JAMA Neurol. 2015 Jan;72(1):73-80. doi: 10.1001/jamaneurol.2014.3071.
- Background: PubMed 28688529Domenick Sridharan N, Thirumala P, Chaer R, Balzer J, Long B, Crammond D, Makaroun M, Avgerinos E. Predictors of cross-clamp-induced intraoperative monitoring changes during carotid endarterectomy using both electroencephalography and somatosensory evoked potentials. J Vasc Surg. 2018 Jan;67(1):191-198. doi: 10.1016/j.jvs.2017.04.064. Epub 2017 Jul 5.
- Background: PubMed 18639412Friedell ML, Clark JM, Graham DA, Isley MR, Zhang XF. Cerebral oximetry does not correlate with electroencephalography and somatosensory evoked potentials in determining the need for shunting during carotid endarterectomy. J Vasc Surg. 2008 Sep;48(3):601-6. doi: 10.1016/j.jvs.2008.04.065. Epub 2008 Jul 18.
- Background: PubMed 19497494Tan TW, Garcia-Toca M, Marcaccio EJ Jr, Carney WI Jr, Machan JT, Slaiby JM. Predictors of shunt during carotid endarterectomy with routine electroencephalography monitoring. J Vasc Surg. 2009 Jun;49(6):1374-8. doi: 10.1016/j.jvs.2009.02.206.
- Backgroundhttps://www.masimo.com/technology/brain-monitoring/cerebral-oximetry
- Backgroundhttps://www.masimo.com/siteassets/us/documents/pdf/plm_11661c_brochure_o3_series_us.pdf
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Endarterectomy, run by Cleveland Clinic Abu Dhabi at 1 site in United Arab Emirates.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 28 Oct 2026. 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 United Arab Emirates. 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 was stopped early (reason given: Due to the change in the surgical approach, it is not possible to recruit future patients. Future patients will have this type of surgical intervention by a vascular surgeon, where EEG and SSEP are not applied during the surgery.). Results are not available in the source record.
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?
Correlation between new O3 regional oximetry monitoring, electroencephalography and SSEP in CEA. (time frame: The anticipated duration will not exceed duration of surgery.). 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 NCT05267782, which also lists 6 linked publications.
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 28 Oct 2026.