Evaluation of the Correlation Between Carotid Stump Pressure and Interhemispheric rSO₂ Asymmetry in Awake Carotid Endarterectomy: A Prospective Cohort Study

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Izmir Katip Celebi University Atatürk Training and Research Hospital
RECRUITING
Izmir
Contact Information
Primary
Ahmet Salih Tüzen, M.D.
astuzen@icloud.com
+90 535 391 55 77
Backup
Murat Aksun, M.D.
murataksun@yahoo.com
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 60
Treatments
Cerebral Asymmetry Group (>10% rSO₂ Difference)
This group includes patients who exhibit a significant interhemispheric cerebral oxygenation asymmetry during awake carotid endarterectomy, defined as an absolute difference in ΔrSO₂ greater than 10% between the ipsilateral (surgical) and contralateral hemispheres.
Cerebral Symmetry Group (≤10% rSO₂ Difference)
This group includes patients who exhibit a nonsignificant interhemispheric cerebral oxygenation asymmetry during awake carotid endarterectomy, defined as an absolute difference in ΔrSO₂ lesser than 10% between the ipsilateral (surgical) and contralateral hemispheres.
Sponsors
Leads: Izmir Katip Celebi University

This content was sourced from clinicaltrials.gov