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

February 6, 2024 updated by: Boris Tufegdzic, Cleveland Clinic Abu Dhabi

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
The anticipated duration will not exceed duration of surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cleveland Clinic Abu Dhabi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

February 24, 2022

First Submitted That Met QC Criteria

February 24, 2022

First Posted (Actual)

March 4, 2022

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A-2022-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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