The Effects of Different Extracorporeal Circulation Techniques on Cerebral Perfusion Markers and Postoperative Awakening in Coronary Artery Bypass Graft Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Perioperative Optic Nerve Sheath Diameter (ONSD)
研究概览
简要总结
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.
详细描述
Introduction
Despite advances in minimally invasive approaches and technical improvements in extracorporeal circulation systems in cardiac surgery, postoperative morbidity and mortality remain clinically significant. One of the main contributors to these adverse outcomes is the non-physiological nature of cardiopulmonary bypass, which disrupts circulatory dynamics and may negatively affect cerebral perfusion and oxygenation. Impairment of cerebral perfusion is closely associated with postoperative neurological complications, prolonged awakening time, and extended intensive care unit stay.
Early and reliable monitoring of cerebral perfusion during cardiac surgery is critical for preventing potential neurological injury. Although changes in intracranial pressure are an important determinant of cerebral perfusion, invasive monitoring methods have limited routine clinical use. Ultrasonographic measurement of optic nerve sheath diameter has emerged as a non-invasive, rapid, and repeatable method reflecting changes in intracranial pressure. However, the use of optic nerve sheath diameter measurement in cardiac surgery, particularly for evaluating the cerebral effects of different extracorporeal circulation techniques, has not been sufficiently investigated.
Minimal invasive extracorporeal circulation systems, with their closed-circuit design, reduced hemodilution, and better preservation of hemodynamic stability, may offer potential advantages in maintaining cerebral perfusion compared with conventional reservoir-based extracorporeal circulation. While these potential benefits have been evaluated mainly through clinical outcomes, clear evidence examining cerebral perfusion, oxygenation, and their relationship with intracranial pressure changes is lacking. Near-infrared spectroscopy allows non-invasive monitoring of cerebral oxygenation, and its combined use with optic nerve sheath diameter measurement may enable simultaneous assessment of both functional and pressure-related components of cerebral perfusion.
The present study aims to compare the effects of minimal invasive extracorporeal circulation and conventional reservoir-based extracorporeal circulation techniques on cerebral perfusion in patients undergoing elective coronary artery bypass graft surgery, using ultrasonographic optic nerve sheath diameter measurements. The primary hypothesis is that minimal invasive extracorporeal circulation limits increases in intracranial pressure and provides better preservation of cerebral perfusion and oxygenation compared with conventional extracorporeal circulation. The primary objective is to compare the effects of the two circulation techniques on optic nerve sheath diameter. Secondary objectives include evaluation of the relationship between optic nerve sheath diameter and near-infrared spectroscopy measurements, incidence of cerebrovascular events, extubation time, duration of intensive care unit and hospital stay, perioperative hemodynamic parameters, and postoperative complication rates.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Ocular trauma
- •Optic nerve pathology
研究组 & 干预措施
Conventional Extracorporeal Circulation (cECC) Group
Patients undergoing elective coronary artery bypass graft surgery using a conventional reservoir-based extracorporeal circulation system. Perioperative cerebral perfusion will be evaluated using ultrasonographic optic nerve sheath diameter measurements and near-infrared spectroscopy monitoring.
Minimal Invasive Extracorporeal Circulation (MiECC) Group
Patients undergoing elective coronary artery bypass graft surgery using a minimal invasive extracorporeal circulation system. Cerebral perfusion will be assessed perioperatively using ultrasonographic optic nerve sheath diameter measurements and near-infrared spectroscopy monitoring.
结局指标
主要结局
Perioperative Optic Nerve Sheath Diameter (ONSD)
时间窗: Before initiation of cardiopulmonary bypass (CPB), during CPB, and immediately after completion of CPB (within the intraoperative period).
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.
次要结局
- Cerebral Oxygenation (NIRS)(From before induction of anesthesia through the intraoperative period until completion of anesthesia.)
- Correlation Between ONSD and NIRS(Correlation analysis performed using intraoperative ONSD and NIRS measurements obtained before CPB, during CPB, and after CPB within the intraoperative period)
- Incidence of Cerebrovascular Events(From completion of surgery to the occurrence of a postoperative cerebrovascular event or hospital discharge, whichever occurred first, assessed up to 30 postoperative days)
- Extubation Time(From completion of surgery to successful tracheal extubation in the intensive care unit, assessed up to 30 postoperative days.)
- Duration of Mechanical Ventilation(From completion of surgery to successful tracheal extubation in the intensive care unit, assessed up to 30 postoperative days.)
- Length of Intensive Care Unit Stay(From completion of surgery to discharge from the intensive care unit, assessed during the index hospitalization, up to 30 postoperative days.)
研究者
Mustafa Burgaç
Specialist physician
Kartal Kosuyolu High Speciality Training and Research Hospital