The Efficacy of Driving Pressure-guided Lung Protective Ventilation in Surgical Repair of Acute Type A Aortic Dissection: an Open-label, Randomized Control Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- The incidence of postoperative hypoxemia
研究概览
简要总结
The study, named as "The Efficacy of Driving Pressure-guided Lung Protective Ventilation in Surgical Repair of Acute Type A Aortic Dissection: an open-label, randomized control clinical trial", aims to investigate whether driving pressure-guided lung protective ventilation can reduce postoperative oxygenation function in patients who have undergone surgical repair of acute type A aortic dissection. The primary outcomes is the incidence of postoperative hypoxemia (a partial pressure of arterial oxygen to inspiratory oxygen fraction ratio less than 300 mm Hg or a peripheral blood oxygen saturation less than 93% at any concentration of inspiratory oxygen) within 7 days after the surgery.
详细描述
Postoperative hypoxemia is defined as a partial pressure of arterial oxygen to inspiratory oxygen fraction ratio less than 300 mm Hg or a peripheral blood oxygen saturation less than 93% at any concentration of inspiratory oxygen. Acute type A aortic dissection is a lethal disease requiring emergency surgery. Compared with non-cardiac surgery, hypoxemia frequently occurs after surgical repair for acute type A aortic dissection which has been reported to be 52%-67.6%, and the possible mechanisms are as followed: (1) systemic inflammatory reaction induced by massive thrombosis formation and long duration of extracorporeal circulation; (2) ischemia-perfusion injury in lung; and (3) a massive perioperative transfusion. Postoperative hypoxemia has been reported to be associated with prolonged duration of extubation, length of stay in ICU and respiratory failure, which contributes a high mortality of 20% to 44%.
Driving pressure, defined as the difference between platform airway pressure and positive end-expiratory pressure, was first introduced by Amato and his colleagues in their meta-analysis study on acute respiratory distress syndrome in 2015, demonstrating that driving pressure was most strongly associated with survival among various ventilation parameters. A lower driving pressure has been verified to be closely relative to an ameliorative prognosis after surgery. However, controversy persists regarding whether driving pressure-guided ventilation can decrease the incidences of postoperative hypoxemia and other pulmonary complications in the patients underwent surgical repair of acute type A aortic dissection.
Given the need for additional evidence to confirm the relationship between driving pressure and postoperative hypoxemia in the patients with acute type A aortic dissection, this open-label, randomized control clinical trial aims to assess the efficacy and safety of the driving pressure-guided lung protective ventilation strategy in preventing hypoxemia and other pulmonary complications after the surgical repair for acute type A aortic dissection.
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
- None
入排标准
- 年龄范围
- 14 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to sign Informed Consent and Release of Medical Information Forms;
- •Age ≥ 14 years and ≤ 70 years old;
- •Being confirmed the diagnosis by chest computed tomography angiography and receiving the surgical repair of acute type A aortic dissection.
排除标准
- •Age < 14 years or > 70 years old;
- •Sepsis before surgery;
- •Chronic pulmonary disease including lung infection or asthma requiring long-term pharmacotherapy;
- •History of lung tumor;
- •Obstructive sleep apnea hypopnea syndrome requiring long-term noninvasive mechanical ventilation support;
- •Heart failure requiring catecholamines or invasive mechanical ventilation support;
- •Body mass index > 30 Kg·m-2;
- •Being reluctance to participate this study.
研究组 & 干预措施
Driving pressure-guided lung protective ventilation during the surgery
A 10-cycle experimental ventilation will be carried out at each level of positive end expiratory pressure after intubation, and the driving pressure of the last cycle will be recorded. The positive end expiratory pressure value corresponding to the lowest driving pressure is recognised as the optimal ventilation parameter.
干预措施: Driving pressure-guided positive end expiratory pressure (Procedure)
Driving pressure-guided lung protective ventilation during the surgery
A 10-cycle experimental ventilation will be carried out at each level of positive end expiratory pressure after intubation, and the driving pressure of the last cycle will be recorded. The positive end expiratory pressure value corresponding to the lowest driving pressure is recognised as the optimal ventilation parameter.
干预措施: Ventilation strategy (Procedure)
Driving pressure-guided lung protective ventilation during the surgery
A 10-cycle experimental ventilation will be carried out at each level of positive end expiratory pressure after intubation, and the driving pressure of the last cycle will be recorded. The positive end expiratory pressure value corresponding to the lowest driving pressure is recognised as the optimal ventilation parameter.
干预措施: Management of hypoxemia (Procedure)
Conventional lung protective ventilation
Positive end expiratory pressure will be maintained at the level facilitating optimal oxygenation during the off-pump period.
干预措施: Optimal oxygenation-guided positive end expiratory pressure (Procedure)
Conventional lung protective ventilation
Positive end expiratory pressure will be maintained at the level facilitating optimal oxygenation during the off-pump period.
干预措施: Ventilation strategy (Procedure)
Conventional lung protective ventilation
Positive end expiratory pressure will be maintained at the level facilitating optimal oxygenation during the off-pump period.
干预措施: Management of hypoxemia (Procedure)
结局指标
主要结局
The incidence of postoperative hypoxemia
时间窗: Within 7 days after surgery
Postoperative hypoxemia is defined as a partial pressure of arterial oxygen to inspiratory oxygen fraction ratio less than 300 mm Hg or a pulse oximetry less than 93% at any concentration of inspiratory oxygen that occurred from admission to the operating room to 7 days post-surgery.
次要结局
- Early/late death(Within 30 days after surgery)
- Ventilation assistance time(Depending on the time point of extubation, not exceeding 30 days)
- The trend of perioperative oxygenation function(Within 7 days after surgery)
- Length of stay in intensive care unit(Within 30 days after surgery)
- Vasoactive-inotropic score at the end of surgery(Within 7 days after surgery)
- Postoperative extrapulmonary complications(Within 7 days after surgery)
- Postoperative pulmonary complications except hypoxemia(Within 7 days after surgery)
- Postoperative adverse cardiovascular events(Within 7 days after surgery)
研究者
Yong Lin, PhD
Associate chief physician
Fujian Medical University Union Hospital