Correlation Between Carotid Stump Pressure and Interhemispheric rSO₂ Asymmetry During Awake Carotid Endarterectomy

Recruiting now

Conditions studied: Carotid Artery Stenosis Symptomatic, Carotid Endarterectomy (CEA) Surgical Patients, Cerebral Hypoperfusion

In brief

This study aims to better understand how well the brain is perfused (supplied with blood and oxygen) during a specific type of surgery called carotid endarterectomy (CEA), which is performed to prevent strokes in people with stenosis of carotid arteries. During this surgery, the surgeon temporarily clamps the carotid artery to remove a blockage, which can reduce blood flow to the brain. Monitoring brain oxygen levels during this time is important to prevent brain injury. Two common monitoring methods are: Stump pressure (SP) - a pressure measurement taken from the carotid artery during surgery. Near-infrared spectroscopy (NIRS) - a non-invasive technique that tracks brain oxygen levels in real time. This study focuses on the relationship between carotid stump pressure and differences in brain oxygenation between the two sides of the brain (interhemispheric asymmetry), as measured by NIRS. The study will include patients undergoing awake CEA (under regional anesthesia) at a single center university hospital. Oxygen levels in both hemispheres of the brain will be monitored before and after the carotid artery is clamped after 3 minutes. Stump pressure will also be measured. The researchers will examine whether low stump pressure is linked to greater differences in brain oxygen levels between the two sides. The primary goal is to determine whether a large difference in brain oxygenation between the two hemispheres (greater than 10%) is associated with low carotid stump pressure. Secondary goals include identifying a stump pressure threshold that predicts significant asymmetry and analyzing the influence of patient and surgical factors. The findings may help improve how surgeons and anesthesiologists monitor and protect the brain during CEA, particularly in patients who are awake and can be observed for neurological changes.

Key facts

Study ID

NCT07150260

Run by

Izmir Katip Celebi University

People needed

60

Starts

2025-09-01

Expected to finish

2026-10-01

Last updated by the study team

2026-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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 it is running

• Izmir Katip Celebi University Atatürk Training and Research Hospital — Izmir, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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