Hemodynamic Changes During Displacement of the Heart in the Aorta No-touch Off-pump Coronary Artery Bypass Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in continuous cardiac index
研究概览
简要总结
Introduction: Aorta no-touch off-pump coronary artery bypass surgery (OPCAB) has been the recommended technique for treatment of patients with high-risk of neurological damage or stroke. However, the displacement of the heart to achieve suitable exposure for graft construction elicits hemodynamic changes, potentially requiring conversion to on-pump. Objective: The aim of this study is to evaluate the sequential changes of hemodynamic parameters in patients that undergo aorta no-touch OPCAB. Method: Patients that undergo aorta no-touch OPCAB will be evaluated. The FloTrac / PreSep / Vigileo ™ (Edwards Lifesciences) system will be used to continuously record heart rate (HR), mean arterial pressure (DBP), central venous pressure (CVP), continuous cardiac index, systolic volume , systolic volume variation (VVS) and central venous oxygen saturation (ScvO2). The parameters will be evaluated 5 min before, during and 5 min after each anastomosis (left anterior descending-LAD, posterior descending PD, marginal-OM and diagonal-Dg). Postoperative lactate will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with a diagnosis of coronary artery disease with indication of myocardial revascularization surgery
排除标准
- •patients will be excluded if they presented clinically significant preoperative hepatic or renal dysfunction, thrombocytopenia, coagulopathy, or uncontrolled arrhythmia.
研究组 & 干预措施
Aorta no-touch
Aorta no-touch off-pump coronary artery bypass surgery.
干预措施: Aorta no-touch (Procedure)
结局指标
主要结局
Change in continuous cardiac index
时间窗: The parameters will be assessed 5 min before, during and 5 min after each anastomosis (left anterior descending-LAD, posterior descending-PD, marginal-OM and diagonal-Dg).
By the FloTrac/PreSep/Vigileo™ system (Edwards Lifesciences), assessing the change in continuouns cardiac index during procedures
Change in heart rate
时间窗: The parameters will be assessed 5 min before, during and 5 min after each anastomosis (left anterior descending-LAD, posterior descending-PD, marginal-OM and diagonal-Dg).
By the FloTrac/PreSep/Vigileo™ system (Edwards Lifesciences), assessing the change in heart rate during procedures
Change in central venous pressure
时间窗: The parameters will be assessed 5 min before, during and 5 min after each anastomosis (left anterior descending-LAD, posterior descending-PD, marginal-OM and diagonal-Dg).
By the FloTrac/PreSep/Vigileo™ system (Edwards Lifesciences), assessing the change in central venous pressure during procedures
Change in stroke volume
时间窗: The parameters will be assessed 5 min before, during and 5 min after each anastomosis (left anterior descending-LAD, posterior descending-PD, marginal-OM and diagonal-Dg).
By the FloTrac/PreSep/Vigileo™ system (Edwards Lifesciences), assessing the change in stroke volume during procedures
Change in mean arterial blood pressure
时间窗: The parameters will be assessed 5 min before, during and 5 min after each anastomosis (left anterior descending-LAD, posterior descending-PD, marginal-OM and diagonal-Dg).
By the FloTrac/PreSep/Vigileo™ system (Edwards Lifesciences), assessing the change in mean arterial blood pressure during procedures
Change in central venous oxygen saturation
时间窗: The parameters will be assessed 5 min before, during and 5 min after each anastomosis (left anterior descending-LAD, posterior descending-PD, marginal-OM and diagonal-Dg).
By the FloTrac /PreSep/Vigileo™ system (Edwards Lifesciences), assessing the change in central venous oxygen saturation during procedures
次要结局
- Evaluate lactate levels(Immediate postoperative period, at the admission on the intensive care unit)
研究者
Solange Guizilini
Principal Investigator
Federal University of São Paulo