About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age < 18 years
ASA physical status other than II-III
Emergency surgery
Pregnancy
Trial population
The study population consists of adult patients aged 18 years and older with American Society of Anesthesiologists (ASA) physical status II-III who are scheduled to undergo elective coronary artery bypass graft surgery with the use of extracorporeal circulation. All participants will be treated according to standard clinical practice in a tertiary cardiac surgery center and will provide written informed consent prior to enrollment.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Perioperative Optic Nerve Sheath Diameter (ONSD)
Perioperative changes in optic nerve sheath diameter will be measured using ultrasonography to evaluate the effects of different extracorporeal circulation techniques on intracranial pressure-related cerebral perfusion.
Secondary outcomes
Cerebral Oxygenation (NIRS)
Perioperative cerebral regional oxygen saturation values measured using near-infrared spectroscopy to assess cerebral oxygenation under different extracorporeal circulation techniques.
Correlation Between ONSD and NIRS
Assessment of the relationship between perioperative optic nerve sheath diameter and near-infrared spectroscopy measurements
Incidence of Cerebrovascular Events
Occurrence of postoperative cerebrovascular events during hospital stay.
Extubation Time
Time from completion of surgery to successful tracheal extubation.
Sponsors and contacts
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