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
- 1
- 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.
详细描述
Background: Cardiac surgery is performed with the use of extracorporeal circulation which triggers a systemic inflammatory response leading to end-organ dysfunction. Contemporary minimal invasive extracorporeal circulation represents an evolution of the conventional extracorporeal circulation that reduces systemic inflammatory response and improves clinical outcome in large studies. A potential explanation includes preservation of tissue microcirculation with minimal invasive extracorporeal circulation as the underlying pathophysiologic mechanism.
Aim: The aim of the present study is to detect differences in tissue microcirculation during cardiopulmonary bypass with minimal (study group) versus conventional (control group) in patients undergoing open heart surgery.
Study type: This is a randomized comparative study. Patients: The study group consists of sixty patients scheduled for elective open-heart surgery (coronary artery bypass grafting, aortic valve replacement of combined procedure) at the Cardiothoracic Department School of Medicine Aristotle University of Thessaloniki.
Intervention: Patients included in the study will be randomly assigned in two groups with a computer-generated algorithm. Study group will undergo cardiac surgery with minimal invasive extracorporeal circulation while control group will be operated with the use of conventional extracorporeal circulation.
Protocol: In both groups tissue microcirculation will be assessed with the use of a specifically designed second generation hand-held video monitoring device which uses sidestream dark field (SDF) imaging placed at the sublingual mucosa. Microcirculatory assessments will be performed at the following time-points: before induction of anesthesia (baseline - T0), after induction of general anesthesia (T1), after initiation of cardiopulmonary bypass (T2) and immediately after weaning cardiopulmonary bypass (T3).
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
研究组 & 干预措施
Minimal Invasive Extracorporeal Circulation (MiECC)
Patients undergoing cardiac surgery with Minimal Invasive Extracorporeal Circulation.
干预措施: Sublingual microscopy (Device)
Conventional cardiopulmonary Bypass (cCPB)
Patients undergoing cardiac surgery with conventional cardiopulmonary bypass.
干预措施: Sublingual microscopy (Device)
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.
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.
Total vascular density assessed with sublingual microscopy
时间窗: During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Total vascular density (TVD) assessed with sublingual microscopy.
Microvascular Flow Index (MFI)
时间窗: During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Microvascular Flow Index (MFI) assessed with sublingual microscopy
次要结局
- Peak lactate levels(During surgery from induction to weaning of cardiopulmonary bypass)
- Mean arterial pressure(During surgery from induction to weaning of cardiopulmonary bypass)
- Overall mortality rate(From surgery to 30 days postoperatively)
- Rate of preoperative myocardial infarction(From surgery to 30 days postoperatively)
- Rate of postoperative stroke(From surgery to 30 days postoperatively)
- Rate of postoperative revascularization(From surgery to 30 days postoperatively)
- Length of hospital stay(Perioperatively, from the day of operation up to 4 weeks after surgery)
- Rate of postoperative renal failure(From surgery to 30 days postoperatively)
- Rate of re-intubation(From surgery to 30 days postoperatively)
- Rate of re-operation(From surgery to 30 days postoperatively)
- Volume of postoperative bleeding(From ICU admission to 12 hours postoperatively)
- Rate of blood product transfusion(Postoperatively up to 30 days)
- Length of ICU stay(Perioperatively, up to 4 weeks after surgery)
研究者
Kyriakos Anastasiadis
Professor of Cardiac Surgery, Head of Cardiothoracic Department
Aristotle University Of Thessaloniki