Actively Recruiting

Age: 18Years +
All Genders
ID07150260

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

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)

Post-operative Follow-up

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

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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

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