Carotid stump pressure and side-to-side brain oxygen differences during awake carotid surgery
Evaluation of the Correlation Between Carotid Stump Pressure and Interhemispheric rSO₂ Asymmetry in Awake Carotid Endarterectomy: A Prospective Cohort Study
Izmir Katip Celebi University · NCT07150260
This will test whether carotid stump pressure relates to differences in brain oxygen measured by NIRS in adults having awake carotid endarterectomy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Izmir Katip Celebi University (other) |
| Locations | 1 site (Izmir) |
| Trial ID | NCT07150260 on ClinicalTrials.gov |
What this trial studies
Carotid endarterectomy briefly interrupts blood flow to one side of the brain, and both carotid stump pressure (SP) and near-infrared spectroscopy (NIRS) are used to monitor cerebral perfusion during the procedure. This prospective, single-center observational cohort will enroll adults undergoing awake CEA under regional anesthesia with bilateral NIRS monitoring and intraoperative SP measurement after cross-clamping. Measurements will be recorded at baseline and after cross-clamping to quantify interhemispheric rSO2 asymmetry and its association with SP values. The study aims to determine whether SP correlates with NIRS-detected side-to-side oxygenation differences that might indicate inadequate collateral flow.
Who should consider this trial
Good fit: Adults (≥18 years) scheduled for elective awake carotid endarterectomy under regional (superficial cervical plexus) anesthesia who can have bilateral NIRS monitoring and intraoperative stump pressure measurement are ideal candidates.
Not a fit: Patients who require general anesthesia, have incomplete NIRS or SP recordings, prior ipsilateral carotid surgery or stenting, recent major stroke or recent myocardial infarction, or other intraoperative technical issues are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the findings could help clinicians use SP and NIRS asymmetry together to better identify intraoperative cerebral hypoperfusion and guide shunting decisions to reduce ischemic complications.
How similar studies have performed: Both stump pressure and NIRS have been used clinically as monitoring tools, but correlating SP with interhemispheric rSO2 asymmetry during awake CEA is relatively novel and not yet definitively established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years or older * Scheduled for elective carotid endarterectomy (CEA) * Able to tolerate surgery under regional anesthesia (superficial cervical plexus block) * Availability of bilateral regional cerebral oxygen saturation (rSO₂) measurements by near-infrared spectroscopy (NIRS) * Successful intraoperative carotid stump pressure (SP) measurement after cross-clamping * Provided written informed consent Exclusion Criteria: * Incomplete NIRS or SP recordings * Conversion from regional to general anesthesia * Intraoperative technical complications preventing monitoring * History of prior ipsilateral carotid endarterectomy or carotid artery stenting * Recent major stroke with permanent neurological deficit * Recent myocardial infarction within the past 3 months * History of traumatic brain injury within the past 6 months
Where this trial is running
Izmir
- Izmir Katip Celebi University Atatürk Training and Research Hospital — Izmir, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Ahmet Salih Tüzen, M.D: — Izmir Katip Celebi University Atatürk Training and Research Hospital
- Study coordinator: Ahmet Salih Tüzen, M.D.
- Email: astuzen@icloud.com
- Phone: +90 535 391 55 77
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.
Conditions: Carotid Artery Stenosis Symptomatic, Carotid Endarterectomy Surgical Patients, Cerebral Hypoperfusion, Carotid stump pressure, Near-infrared spectroscopy, rSO₂ asymmetry, Cerebral oxygenation, Awake carotid endarterectomy