Phase 4, Randomized, Controlled Trial on the Efficacy as Prophylaxis of Postoperative Respiratory Complications and Safety of Continuous Positive Airways Pressure (CPAP) Applied Throughout Boussignac Mask During the Immediate Postoperative Period of Patients Undergoing Lung Resection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 258
- 试验地点
- 4
- 主要终点
- Frequency of atelectasis- Pneumonia, and other postoperative complications,
研究概览
简要总结
Evaluation of efficacy and safety from 6hours of 7 cmH2O CPAP after weaning in patients undergoing lung resection, on the prevention of atelectasis / pneumonia and gas exchange improve.
详细描述
Multicenter randomized clinical trial. 460 patients randomly assigned to treatment and control groups will be studied. The main variables are the frequency of atelectasis or pneumonia, defined by clinical and radiological criteria, the FiO2/PaO2 ratio, 7 and 24 h after weaning, and hospital stay.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing thoracic surgery including resection of lung parenchyma.
- •To have given signed consent to enter in the study.
排除标准
- •Weaning in the first 4h after the intervention end.
- •Suspected bronchopleural fistula at the admission to the surgical ICU.
- •Patients with facial problems or a history of intolerance to CPAP masks.
- •Having significant bullous emphysema defined as the presence of more than 5 contiguous bullae <2cm or the existence of a pulmonary bulla> 2 cm or dystrophy bullosa, not in the area to dry and having had a previous pneumothorax.
- •Known Obstructive Apnea Hypopnea syndrome known or some form of noninvasive ventilation prescribed.
- •Immunocompromised patients, or having used an immunosuppressor drug at least one month prior to surgery with potential (except corticosteroids administered by inhalation)
研究组 & 干预措施
CPAP plus gas
Treatment with Boussingnac valve CPAP during 6 hour, starting immediately after weaning
干预措施: CPAP plus Gas (Device)
Usual treatment(ventimask plus gas)
ventimask
干预措施: ventimask plus gas (Device)
结局指标
主要结局
Frequency of atelectasis- Pneumonia, and other postoperative complications,
时间窗: 1 week after the surgical intervention
次要结局
- Gas exchange ( Pa/FiO2)(1 week after the surgical intervention)
- Hospital stay comparison between arms(from the surgical intervention date to hospital discharge date up to 1month)