Not Yet RecruitingNot Applicable

Effects of Extracorporeal Circulation Techniques on Cerebral Perfusion in CABG Surgery

Turkey (Türkiye)70 participantsStarted 2026-05-01

Plain-language summary

This prospective study aims to compare the effects of minimal invasive extracorporeal circulation (MiECC) and conventional reservoir-based extracorporeal circulation techniques on cerebral perfusion in patients undergoing elective coronary artery bypass graft (CABG) surgery. Although the adverse effects of cardiopulmonary bypass on cerebral perfusion and oxygenation are well recognized, the relationship between these effects and changes in intracranial pressure has not been fully elucidated. In this context, ultrasonographic measurement of optic nerve sheath diameter (ONSD), a non-invasive surrogate marker of intracranial pressure, will be used in combination with near-infrared spectroscopy (NIRS) to enable a comprehensive assessment of cerebral perfusion and oxygenation. Between February 2026 and February 2027, a total of 70 ASA II-III patients scheduled for elective CABG surgery will be prospectively enrolled and allocated according to the extracorporeal circulation technique used. Perioperative ONSD measurements will be performed by a single anesthesiologist blinded to the perfusion technique. The primary endpoint is the comparison of perioperative changes in ONSD between the two techniques. Secondary endpoints include the correlation between ONSD and NIRS values, incidence of cerebrovascular events, extubation time, duration of intensive care unit and hospital stay, perioperative hemodynamic parameters, and postoperative complications. This study is expected to provide clinically relevant data on the cerebral effects of different extracorporeal circulation strategies and contribute to perioperative neuromonitoring practices in cardiac surgery.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 18 years * Scheduled for elective coronary artery bypass graft (CABG) surgery * American Society of Anesthesiologists (ASA) physical status II-III * Planned use of extracorporeal circulation during surgery * Ability to provide written informed consent Exclusion Criteria: * Age \< 18 years * ASA physical status other than II-III * Emergency surgery * Pregnancy * History of neurological disease affecting consciousness or decision-making capacity * History of psychiatric disease affecting decision-making capacity * History of head trauma within the previous 24 hours * Presence of carotid artery stenosis or significant carotid artery disease * Coagulation disorders (INR \> 1.25, aPTT \> 35 s, or platelet count \< 100,000/μL) * Reoperation (redo cardiac surgery) * Congestive heart failure * Chronic kidney failure * Sepsis * Hypoxia * Ocular trauma * Optic nerve pathology

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Perioperative Optic Nerve Sheath Diameter (ONSD)

Timeframe: Before initiation of cardiopulmonary bypass (CPB), during CPB, and immediately after completion of CPB (within the intraoperative period).

Trial details

NCT IDNCT07420738

SponsorKartal Kosuyolu High Speciality Training and Research Hospital

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2027-05-01

Contact for this trial

Mustafa Burgaç, himself

0 538 984 8198 mustafaburgac@gmail.com

View on ClinicalTrials.gov More Intracranial Hypertension trials