Study of Microcirculation During Extracorporeal Circulation in Cardiac Surgery; Challenging Near-infrared Spectroscopy With Microvascular Density and Metabolic Parameters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluation of microcirculation
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 under 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 under 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 protocol for the evaluation of microcirculation will be based on:
- Cerebral near-infrared spectroscopy (rScO2) measurements (INVOS, Covidien-Medtronic Inc.).
- NIRS-Based Cerebral Autoregulation Monitoring: Analog arterial blood pressure signals will be digitized and then processed with the digital NIRS signals using a personal computer and a special ICM software (University of Cambridge, Cambridge, UK). Monitoring cerebral autoregulation ensures adequate renal perfusion. Hence, brain can be used not just as a target but also as an index organ indicating adequacy of perfusion.
- Somatic near-infrared spectroscopy (rSsO2) measurements (INVOS, Covidien-Medtronic Inc.).
- Sublingual mucosal microcirculation measurements during surgery using side dark field (SDF) imaging (MicroScan, Microvision Medical, Amsterdam, The Netherlands).
All measurements will be performed at the following time points:
T0: after induction of anaesthesia T1: after initiation of cardiopulmonary bypass T2: 10 minutes after cross- clamping the aorta T3: 10 minutes before removing the aortic cross-clamp T4: after weaning from extracorporeal circulation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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 aged > 18 and < 85 years with coronary artery disease and/or aortic valve disease undergoing open heart surgery with accepted indications
排除标准
- •patients undergoing emergency surgery
- •patients in preoperative cardiogenic shock with evidence of tissue malperfusion
- •patients > 85 years of age
- •patients with severe peripheral vascular disease
结局指标
主要结局
Evaluation of microcirculation
时间窗: During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Correlation of NIRS values with tissue microvascular activity
次要结局
- Goal-directed perfusion(During surgery, from induction of anesthesia to weaning of extracorporeal circulation)
- Global perfusion(During surgery, from induction of anesthesia to weaning of extracorporeal circulation)
- Cerebral autoregulation(During surgery, from induction of anesthesia to weaning of extracorporeal circulation)
- Somatic perfusion(During surgery, from induction of anesthesia to weaning of extracorporeal circulation)
研究者
Kyriakos Anastasiadis
Professor of Cardiac Surgery
AHEPA University Hospital