Acute Respiratory Failure After Cardio Thoracic Surgery: Non Invasive Ventilation (VNI) by BIPAP Vision Versus OPTIFLOW System, Comparison.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 830
- 试验地点
- 2
- 主要终点
- Failure of the ventilation system
研究概览
简要总结
The OPTIFLOW ™ use is becoming more common in acute respiratory failure cases, but its place in relation to VNI (Bi-PAP mode) is not yet defined. OPTIFLOW ™ vs the VNI comparison of the use, in the immediate postoperative period, should lead to define the role of each technique and lead to a optimal rationalization of patients management with acute respiratory failure after surgery.
详细描述
Main objective: to determine, if the initiation of OPTIFLOW™ system immediate after cardio/ thoracic surgery with acute respiratory failure or immediate after post extubation in patients at risk, is not less than the start a VNI per BIPAP Vision ®system. In terms of reintubation rates, refusal to continue the technique, or switch to another technique proposed.
Secondary objectives:
- To assess changes in the sensation of dyspnea
- To analyze the skin tolerance and the comfort in this population
- To analyze the evolution of hemodynamic and respiratory parameters
- To compare the number of bronchoscopy performed during the patient's stay in intensive care unit
- Assess the number of postoperative pneumonia and antibiotic consumption
- To determine whether the initiation of any treatment changes in the immediate postoperative length of stay in intensive care and comprehensive.
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
- 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 after cardiac/thoracic surgery with acute respiratory failure defined by the presence of the following criteria:
- •report PaO2/FiO2 <300
- •Respiratory rate> 25 for at least 2 hours
- •Getting involved accessory respiratory muscles
- •paradoxical breathing Or
- •In immediate after extubation, the patient will be eligible if present in the withdrawal test:
- •SaO2 <90% in 12 L of O2 during a trial of spontaneous ventilation tube on
- •PaO2 <10 kPa at a FiO2 ≥ 50% during a VS trial + pressure support
- •The presence of a risk factor: Obesity (BMI> 30), FEVG <40%, Failed extubation prior, stridor
排除标准
- •Previous history of SAS
- •Patient tracheotomy
- •Comas non hypercapnic
- •bradypnea
- •Cardiac arrest
- •Gastric Surgery recent
- •Restlessness, lack of cooperation
- •Nausea, vomiting
- •Hemodynamic instability
结局指标
主要结局
Failure of the ventilation system
时间窗: One week
Failure defined by reintubation rate, refusal to continue the technique, or switch to an another technique proposed breakdown
次要结局
- number of postoperative pneumonia and antibiotic use(one week)
- Skin tolerance and comfort(One week)
- Sensation of dyspnea(one week)
- number of bronchoscopy performed during the patient's stay in Intensive Care Unit(one week)
- Evolution of hemodynamic and respiratory parameters(one week)
- length of stay in intensive care(one week)