Effect of IntraoperatiVe High Positive End-ExpirAtory Pressure (PEEP) With ReCruitment MAneuveRs vs Low PEEP on Major Postoperative Pulmonary Complications and Death After On-pump Cardiac Surgery in High-risk Patients: the VACARM Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 441
- 试验地点
- 10
- 主要终点
- Rate of major pulmonary complications and death
研究概览
简要总结
Controversies remain concerning the best intraoperative mechanical ventilation regimen for major cardiac surgery. While the use of intra operative low tidal volumes is now standard practice, the optimal level of positive end-expiratory pressure (PEEP) and the use of recruitment maneuvers (RM) remain controversial. The aim of this study is to compare two regimens of intraoperative mechanical ventilation on postoperative outcomes in cardiac surgery patients at risk of postoperative pulmonary complications
详细描述
In this randomized controlled trial, cardiac surgery patients at risk of postoperative pulmonary complications will be assigned to intraoperative ventilation with high PEEP and RM or intraoperative mechanical ventilation with low PEEP and without RM. The primary endpoint will be a composite endpoint including major postoperative complications within the first postoperative week and death within the 28 days after surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years-old,
- •Evaluated before cardiopulmonary bypass for any cardiac surgical procedure (e.g. coronary artery bypass grafting, valve, aorta, or combined procedures),
- •With a pulmonary risk score ≥ 2
- •Who gave written informed consent
- •affiliated to a social security system
排除标准
- •BMI > 40kg/m2 ;
- •Left Ventricular Ejection Fraction < 35% ;
- •Preoperative shock ;
- •Aortic surgery with planned circulatory arrest ;
- •Minimally invasive cardiac surgery ;
- •Emergency surgery with patient unable to give written informed consent
- •Heart transplantation
- •Mechanical circulatory support surgery
- •Pregnant or lactating women
- •Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty
研究组 & 干预措施
Intervention group_MRA
Recruitment maneuvers and high PEEP
干预措施: Intervention group_MRA (Procedure)
Control group
No recruitment maneuvers and low PEEP
干预措施: Control group (Procedure)
结局指标
主要结局
Rate of major pulmonary complications and death
时间窗: 28 days after surgery
Major pulmonary complications, defined as prolonged mechanical ventilation \>24h post-operatively, pneumonia (defined according to the 2017 French guidelines) or reintubation for any cause within 7 post-operative days, or death
次要结局
- Evaluate the postoperative blood gases(30 minutes after extubation)
- Evaluate the postoperative blood gases(Day 1)
- Pulmonary function tests(Day -1 or Day 0)
- Pulmonary function tests(Day 3)
- Mortality rate(Day 28)
- Mortality rate(Day 90)
- Biomarkers of systemic inflammation and of epithelial and endothelial aggression(Day 0)
- Rate of patients with hypotension(intraoperative period)
- Evaluate the postoperative blood gases(Day 2)
- Pulmonary function tests(Day 5)
- Daily evaluation of organ failure(Up to 7 days)
- Daily evaluation of delirium(Up to 7 days)
- Rate of Postoperative pulmonary complications (PPC)(within the 28 days after surgery)
- Rate of Postoperative non pulmonary complications(within the 28 days after surgery)
- Ventilation duration, length of stay in ICU and in the study hospital and death(Day 28)
- Mortality rate(Day 180)
- Biomarkers of systemic inflammation and of epithelial and endothelial aggression(Day 1)
- Length of stay in ICU and in the study hospital(Day 180)