Comparative Analysis of the Microcirculation During Cardiac Surgery With Minimal Invasive Versus Conventional Extracorporeal Circulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Perfused vessel density assessed with sublingual microscopy
研究概览
简要总结
The aim of the proposed study is to evaluate microcirculatory alterations in patients undergoing open heart surgery with minimal invasive versus conventional extracorporeal circulation. Positive clinical results evidenced with goal-directed perfusion and cerebral oximetry monitoring could be attributed to preserved microcirculation at tissue level.
详细描述
The aim of the proposed study is to evaluate microcirculatory alterations in patients undergoing open heart surgery with minimal invasive versus conventional extracorporeal circulation.
Microcirculatory changes during cardiac surgery have been investigated mainly during coronary procedures using the conventional extracorporeal circulation.There is no single study in the literature investigating microcirculatory alterations using a perioperative strategy of "physiologic" perfusion.
Positive clinical results evidenced with goal-directed perfusion and cerebral oximetry monitoring could be attributed to preserved microcirculation at tissue level.
All patients will follow the same anaesthetic and perfusion protocol. The patients will be randomized to two arms:
- Patients operated with Minimal Invasive Extracorporeal Circulation (MiECC)
- Patients operated with conventional cardiopulmonary bypass (cCPB)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing undergoing open heart surgery with accepted indications under extracorporeal circulation
排除标准
- •patients undergoing emergency surgery
- •patients in preoperative cardiogenic shock with evidence of tissue malperfusion
- •patients with severe peripheral vascular disease
- •patients unable to give informed consent
结局指标
主要结局
Perfused vessel density assessed with sublingual microscopy
时间窗: During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Perfused vessel density (PVD) assessed with sublingual microscopy.
Total vessel density assessed with sublingual microscopy
时间窗: During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Total vessel density (TVD) assessed with sublingual microscopy.
Proportion of perfused vessels assessed with sublingual microscopy
时间窗: During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Proportion of perfused vessels (PPV) assessed with sublingual microscopy.
次要结局
- Peripheral tissue oximetry(During surgery, from induction of anesthesia to weaning of extracorporeal circulation)
- Cox index assessed with near-infrared spectroscopy(During surgery, from induction of anesthesia to weaning of extracorporeal circulation)
- Cerebral oximetry(During surgery, from induction of anesthesia to weaning of extracorporeal circulation)
研究者
Kyriakos Anastasiadis
Professor of Cardiac Surgery, Head of Cardiothoracic Department
Aristotle University Of Thessaloniki