Effects of Extracorporeal Circulation Techniques on Cerebral Perfusion in CABG Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorKartal Kosuyolu High Speciality Training and Research Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

70 Participants
are grouped into 2 trial groups
Group A: Minimal Invasive Extracorporeal Circulation (MiECC) Group
Group B: Conventional Extracorporeal Circulation (cECC) Group

Trial outcomes

Primary outcomes

1

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.

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

Secondary outcomes

1

Cerebral Oxygenation (NIRS)

Perioperative cerebral regional oxygen saturation values measured using near-infrared spectroscopy to assess cerebral oxygenation under different extracorporeal circulation techniques.

Time frame
From before induction of anesthesia through the intraoperative period until completion of anesthesia.
2

Correlation Between ONSD and NIRS

Assessment of the relationship between perioperative optic nerve sheath diameter and near-infrared spectroscopy measurements

Time frame
Correlation analysis performed using intraoperative ONSD and NIRS measurements obtained before CPB, during CPB, and after CPB within the intraoperative period
3

Incidence of Cerebrovascular Events

Occurrence of postoperative cerebrovascular events during hospital stay.

Time frame
From completion of surgery to the occurrence of a postoperative cerebrovascular event or hospital discharge, whichever occurred first, assessed up to 30 postoperative days
4

Extubation Time

Time from completion of surgery to successful tracheal extubation.

Time frame
From completion of surgery to successful tracheal extubation in the intensive care unit, assessed up to 30 postoperative days.

Other outcomes

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