Effect of Sigh Ventilation on Postoperative Pulmonary Complications in Cardiac Surgery: A Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 686
- 试验地点
- 1
- 主要终点
- Proportion of major postoperative pulmonary complications (Grade ≥ 3 ) through POD7
研究概览
简要总结
The purpose of this trial is to investigate whether sigh ventilation strategy, combining sigh breaths, low tidal volume, and moderate PEEP levels, protects against major pulmonary complications within the first 7 postoperative days after cardiac surgery, as compared with conventional ventilation strategy with low tidal volume, and moderate PEEP levels.
详细描述
Preventing postoperative pulmonary complications with the use of low tidal volume ventilation is now an established consensus. However, low tidal volume promote alveolar collapse in poorly ventilated, dependent regions of the lung.
Recruitment maneuvers, typically delivered at specific intraoperative timepoints, aimed to counteract alveolar collapse promoted by low tidal volume, was found to yield transient physiological benefits. And the PROVECS trial failed to show extra benefit of recruitment maneuvers in cardiac surgery patients in terms of pulmonary complications within the first 7 postoperative days, as compared with low tidal volume ventilation.
Sigh breaths, which involves cyclic deep inflations to re-expand alveoli, potentially providing sustained benefits. The purpose of this trial is to investigate the specific role of sigh breaths for reducing pulmonary complications in cardiac surgery patients already receiving protective ventilation with low tidal volume and moderate PEEP levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •18 years of age or older;
- •Elective cardiac surgery with cardiopulmonary bypass, aortic clamp and cardioplegia;
- •Written informed consent is obtained from patients and/or their legal representatives.
排除标准
- •Emergence surgery;
- •Left ventricular assist device implantation;
- •Planned thoracotomy with one lung ventilation;
- •Undergo concurrent surgical procedures outside cardiology;
- •Neuromuscular illness;
- •Mechanical ventilation within the last 2 weeks before surgery, include CPAP and NIV;
- •Preoperative shock;
- •Preoperative Hypoxemia (PaO2<60mmHg OR SpO2<90% on ambient air);
- •Preoperative left ventricular ejection fraction < 40%;
- •Systolic pulmonary artery pressure > 50 mmHg.
结局指标
主要结局
Proportion of major postoperative pulmonary complications (Grade ≥ 3 ) through POD7
时间窗: From randomization to postoperative day 7
Postoperative pulmonary complications were scored using a grade scale ranging from 0 to 5. Major postoperative pulmonary complications are defined as Grade ≥ 3. Grade 3 (Pleural effusion, pneumonia, pneumothorax, HFNC OR NIV support, re-intubation), Grade 4 (IMV dependence ≥ 48h, HFNC OR NIV dependence ≥ 48h ), Grade 5 (Death).
次要结局
- Severity of postoperative pulmonary complications through POD7(From randomization to postoperative day 7)
- Proportion of major postoperative pulmonary complications (Grade ≥ 3 ) through hospitalization(From randomization up to hospital discharge, assessed up to postoperative day 30)
- Severity of postoperative pulmonary complications through hospitalization(From randomization up to hospital discharge, assessed up to postoperative day 30)
- 30-day mortality(From randomization to postoperative day 30)
- No Ventilatory Support Days by POD7(From randomization to postoperative day 7)
- No Ventilatory Support Days by POD30(From randomization to postoperative day 30)
- Proportion of Acute Respiratory Distress Syndrome through hospitalization(From randomization up to hospital discharge, assessed up to postoperative day 30)
- Hospital length of stay by POD30(From randomization to postoperative day 30)
- Intensive Care Unit length of stay by POD30(From randomization to postoperative day 30)
研究者
Fengmei Guo
Deputy director
Zhongda Hospital