Actively Recruiting
Evaluation of the Correlation Between Carotid Stump Pressure and Interhemispheric rSO2 Asymmetry in Awake Carotid Endarterectomy: A Prospective Cohort Study
Led by Izmir Katip Celebi University · Updated on 2026-01-07
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to better understand how well the brain receives blood and oxygen during awake carotid endarterectomy (CEA), a surgery to prevent strokes in people with narrowed carotid arteries. The study focuses on the relationship between carotid stump pressure (SP), a pressure measurement taken during surgery, and differences in brain oxygen levels between the two sides of the brain, measured by near-infrared spectroscopy (NIRS). This observational study involves patients undergoing awake CEA under regional anesthesia at a single center. During the surgery, blood flow in the carotid artery is temporarily blocked, and brain oxygen levels in both hemispheres are monitored before and three minutes after this clamping using NIRS. Carotid stump pressure is also measured at that time. Patients will be grouped based on whether their brain oxygen level difference between hemispheres is greater than 10% or not. Researchers will analyze how stump pressure relates to this asymmetry, as well as other patient and surgical factors. Participants will undergo continuous brain oxygen monitoring and carotid stump pressure measurement during surgery. Data will be collected before and after clamping to evaluate oxygen differences and pressure values. Additional assessments include heart rate, blood pressure, oxygen levels in blood, and monitoring for surgical complications up to 30 days after surgery. The main outcome is the difference in stump pressure between patients with and without significant brain oxygen asymmetry. This study may help improve brain monitoring during CEA to protect patients from ischemic injury.
CONDITIONS
Brief Title
Correlation Between Carotid Stump Pressure and Interhemispheric rSO₂ Asymmetry During Awake Carotid Endarterectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Intraoperative period (approximately several hours on surgery day)
Participants undergo awake carotid endarterectomy under regional anesthesia with continuous monitoring of cerebral oxygenation and intraoperative carotid stump pressure measurement.
1 surgical visit (in-person)
Duration - 30 days
Participants are monitored for postoperative complications, including neurological deficits or bleeding, within 30 days after surgery.
Follow-up visits as per routine postoperative care
Trial Site Locations
Total: 1 location
1
Izmir Katip Celebi University Atatürk Training and Research Hospital
Izmir, Turkey (Türkiye)
Actively Recruiting
Research Team
A
Ahmet Salih Tüzen, M.D.
M
Murat Aksun, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here