Neurocognitive Outcome After Coronary Artery Bypass Surgery Using Minimal Versus Conventional Extracorporeal Circulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Neurocognitive outcome at 3-month follow-up
研究概览
简要总结
The aim of this study is to assess the effect of minimal (MECC) versus conventional (CECC) extracorporeal circulation on neurocognitive function after elective coronary bypass grafting (CABG) as well as whether this can be attributed to improved cerebral perfusion intraoperatively.
详细描述
Despite improvements in the biocompatibility of cardiopulmonary bypass (CPB) circuits, the activation of inflammatory systemic response can result in clinically relevant organ dysfunction. Regarding the central nervous system, prolonged hypoperfusion and microembolization during conventional CPB have been related to postoperative neurologic impairment with an incidence varying from 30% to 60%. This clinical scenario covers a spectrum from a transient subtle cognitive dysfunction to a permanent stroke. Postoperative cognitive decline (POCD) is characterized as impairment in attention, cognition, recognition, orientation, memory, and learning. It may result in prolonged hospitalization, increased morbidity and mortality, while it has an adverse impact on quality of life after surgery.
Near-infrared spectroscopy (NIRS) provides a continuous and noninvasive monitoring of regional cerebral oxygen saturation (rSO2). Recent studies have shown a significant relationship between intraoperative cerebral oxygen desaturation, indicative of cerebral ischemia, and early POCD in patients undergoing elective coronary bypass grafting (CABG) with conventional extracorporeal circulation (CECC). In an attempt to reduce CPB-inherent side effects, a minimal extracorporeal circulation (MECC) system was developed and it is evaluated in clinical practice. The aim of this pilot study was to define whether there is a difference in early postoperative neurocognitive functioning between patients being operated for CABG on MECC versus CECC systems as well as whether this can be attributed to improved cerebral perfusion intraoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients scheduled for elective coronary artery bypass grafting
排除标准
- •history of psychiatric disorder
- •inability to undergo neuropsychological assessment
- •history of transient ischemic attack or stroke
- •carotid artery stenosis > 60% assessed by duplex ultrasonography
研究组 & 干预措施
MECC Group
Patients operated for elective coronary artery bypass grafting with the use of minimal extracorporeal circulation.
干预措施: Coronary artery bypass grafting with the use of minimal extracorporeal circulation (Procedure)
CECC Group
Group of patients undergoing elective coronary bypass grafting with the use of conventional extracorporeal circulation.
干预措施: Coronary artery bypass grafting under conventional extracorporeal circulation (Procedure)
结局指标
主要结局
Neurocognitive outcome at 3-month follow-up
时间窗: 3 months
Neurocognitive outcome at 3-month follow-up after elective coronary artery bypass grafting with the use of minimal (MECC) versus conventional (CECC) extracorporeal circulation.
次要结局
- Neurocognitive outcome at discharge(7-30 days)
- Episodes of intraoperative cerebral desaturation(During the operation)
研究者
Kyriakos Anastasiadis
Head of Cardiothoracic Department
AHEPA University Hospital
