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Clinical Trials in Turkey / NCT07420738
Recruiting Observational

Effects of Extracorporeal Circulation Techniques on Cerebral Perfusion in CABG Surgery

NCT07420738 · tracked via the Priya Life Science Turkey tracker
Sponsor
Kartal Kosuyolu High Speciality Training and Research Hospital
Phase
Observational
Started
2026-05-01
Last updated
2026-08-05

Condition(s) studied

Intracranial Hypertension

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Kosuyolu High Specialization Training and Research Hospital Istanbul Turkey (Türkiye) Recruiting

More Kartal Kosuyolu High Speciality Training and Research Hospital trials in Turkey

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07420738 on ClinicalTrials.gov ↗ ← All trials in Turkey