Salvage Treatment of Inhaled Nitric Oxide in Patients With Refractory Hypoxemia After Aortic Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mechanical ventilation time (days)
研究概览
简要总结
Hypoxemia is a common complication after aortic surgery. As this complication has an adverse effect on the postoperative course of the patient, early treatment is important; however, the mechanism of hypoxemia after surgery for acute aortic dissection remains unclear. Recently, the investigators found that inhaled Nitric Oxide can improve the oxygenation in some of these patients. The investigators are trying to evaluate the effectiveness and safety of inhaled Nitric Oxide in patients with refractory hypoxemia after aortic surgery.
详细描述
Several risk factors for severe hypoxemia after aortic surgery have been reported including advanced age, obesity, smoking history, previous heart surgery,emergency surgery,reduced cardiac function, advanced chronic obstructive pulmonary disease, excessive volume of blood transfusion,and prolonged CPB time. The routine treatment includes lung protective mechanical ventilation, recruitment maneuvers and glucocorticoids.
No previous clinical studies have reported the effectiveness and safety of inhaled Nitric Oxide in patients with refractory hypoxemia after aortic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Adult patients with refractory hypoxemia after aortic surgery;
- •Accepting invasive mechanical ventilation;
- •Chest X-ray and lung ultrasound to exclude the respiratory factors (eg. pulmonary edema, obstructive atelectasis, pleural effusion, pneumothorax) and hemodynamic factors (pericardial tamponade, acute pulmonary hypertension, intracardiac shunt);
- •The ventilator parameters: PEEP>10cmH2O, VT 6-8ml/kg;
- •The PaO2/FiO2 <= 100mmHg.
排除标准
- •Age <18 years old;
- •Pregnant women;
- •Past medical history included COPD or mental illness;
- •The serious infection or sepsis patients;
- •Patients with pulmonary hypertension and right ventricular dysfunction
研究组 & 干预措施
iNO Group
Patients are treated with iNO at a concentration of 5-10 ppm for 3-5 days according to the clinical conditions
干预措施: Inhaled Nitric Oxide (Drug)
iNO Group
Patients are treated with iNO at a concentration of 5-10 ppm for 3-5 days according to the clinical conditions
干预措施: lung protective mechanical ventilation (Device)
iNO Group
Patients are treated with iNO at a concentration of 5-10 ppm for 3-5 days according to the clinical conditions
干预措施: Hemodynamic monitoring (Device)
Control
Patients are treated without iNO.
干预措施: lung protective mechanical ventilation (Device)
Control
Patients are treated without iNO.
干预措施: Hemodynamic monitoring (Device)
结局指标
主要结局
Mechanical ventilation time (days)
时间窗: During whole ICU stay. From date of randomization until the date of death or discharge from ICU, up to 6 months.
次要结局
- ICU mortality(From date of randomization until the date of death or discharge from ICU, up to 6 months.)
- length of hospital stay (days)(From date of randomization until the date of death or discharge from hospital, up to 6 months.)
- length of ICU stay (days)(From date of randomization until the date of death or discharge from ICU, up to 6 months.)
- hospital mortality(From date of randomization until the date of death or discharge from hospital, up to 6 months.)
研究者
Guowei Tu
Attending doctor, Department of cardiac surgery intensive care unit, Principal Investigator
Shanghai Zhongshan Hospital