Monitoring brain function during carotid artery surgery
Correlation Between New O3 Regional Oximetry, Electroencephalography and the Somatosensory Evoked Potential in Carotid Endarterectomy Surgery
This study is testing new ways to monitor brain function during carotid artery surgery to see if it can help improve patient safety and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cleveland Clinic Abu Dhabi Academic / other |
| Locations | 1 site (Abu Dhabi) |
| Trial ID | NCT05267782 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the correlation between new O3 regional oximetry, electroencephalography (EEG), and somatosensory evoked potentials (SSEP) in patients undergoing carotid endarterectomy (CEA). The aim is to enhance the monitoring of cerebral ischemia during surgery, potentially improving patient outcomes by utilizing a multimodal approach to intraoperative monitoring. The study will involve patients over 18 years old who are classified as ASA I to III and are scheduled for CEA at Cleveland Clinic Abu Dhabi.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old scheduled for carotid endarterectomy with an ASA classification of I to III.
Not a fit: Patients with ASA classification IV and V, those with skin abnormalities affecting sensor placement, or those who are cognitively impaired may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring techniques that reduce the risk of stroke during carotid endarterectomy surgeries.
How similar studies have performed: Previous studies have indicated that multimodal monitoring techniques, including EEG and SSEP, can enhance diagnostic accuracy during similar surgical procedures.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Abu Dhabi
- Cleveland Clinic Abu Dhabi — Abu Dhabi, United Arab Emirates (Recruiting)
Study contacts
- Study coordinator: Boris Tufegdzic, MD
- Email: tufegdb@clevelandclinicabudhabi.ae
- Phone: +971 2 659 0200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.