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Correlation Between New O3 Regional Oximetry, Electroencephalography and the Somatosensory Evoked Potential in Carotid Endarterectomy Surgery

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ClinicalTrials.gov Identifier: NCT05267782
Recruitment Status : Recruiting
First Posted : March 4, 2022
Last Update Posted : July 20, 2022
Sponsor:
Information provided by (Responsible Party):
Boris Tufegdzic, Cleveland Clinic Abu Dhabi

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment
Carotid Endarterectomy Device: Masimo's O3 Regional Oximetry

Study Design
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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Correlation Between New O3 Regional Oximetry, Electroencephalography and the Somatosensory Evoked Potential in Carotid Endarterectomy Surgery
Actual Study Start Date : April 1, 2022
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : March 31, 2023
Groups and Cohorts
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Intervention Details:
  • Device: Masimo's O3 Regional Oximetry
    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

Outcome Measures
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Primary Outcome Measures :
  1. Correlation between new O3 regional oximetry monitoring, electroencephalography and SSEP in CEA. [ Time Frame: The anticipated duration will not exceed duration of surgery. ]

Secondary Outcome Measures :
  1. 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. ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  1. Subjects older than 18 years of age
  2. Subjects undergoing carotid endarterectomy.
  3. American Society of Anaesthesiologists Classification (ASA) score I to III.

Exclusion Criteria:

  1. American Society of Anaesthesiologists Classification (ASA) score IV and V.
  2. Subject has skin abnormalities affecting the sensor placement
  3. Emergency cases
  4. Cognitive/Mentally impaired or unable to provide consent
  5. Pregnant subject
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05267782


Contacts
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Contact: Boris Tufegdzic, MD +971 2 659 0200 ext 48458 tufegdb@clevelandclinicabudhabi.ae
Contact: Francisco Lobo, MD LoboF@ClevelandClinicAbuDhabi.ae

Locations
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United Arab Emirates
Cleveland Clinic Abu Dhabi Recruiting
Abu Dhabi, United Arab Emirates, 0000
Contact: Boris Tufegdzic, MD       TufegdB@ClevelandClinicAbuDhabi.ae   
Sponsors and Collaborators
Cleveland Clinic Abu Dhabi
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:
https://www.masimo.com/technology/brain-monitoring/cerebral-oximetry
https://www.masimo.com/siteassets/us/documents/pdf/plm_11661c_brochure_o3_series_us.pdf

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Responsible Party: Boris Tufegdzic, Associate Professor, Cleveland Clinic Abu Dhabi
ClinicalTrials.gov Identifier: NCT05267782    
Other Study ID Numbers: A-2022-005
First Posted: March 4, 2022    Key Record Dates
Last Update Posted: July 20, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boris Tufegdzic, Cleveland Clinic Abu Dhabi:
O3 regional oximetry
somatosensory evoked potential
electroencephalography
carotid endarterectomy surgery