Continuous Positive Airway Pressure (CPAP) for Preventing Respiratory Failure After Laparoscopic Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Incidence of postoperative respiratory failure (PaO2<60mmHg, FEV1<70% of baseline)
研究概览
简要总结
Aim of this study is verify if postoperative CPAP after laparoscopic prostatectomy may reduce the impact of postoperative respiratory failure, defined as occurrence of hypoxemia (PaO2<60 mmHg) and/or reduction of Forced Expiratory Volume in 1 second (FEV1) beyond 70% of basal value.
详细描述
Laparoscopic radical prostatectomy (LRP) is a wide used, well tolerated procedure. However, the general anesthesia, the need for pneumoperitoneum and Trendelenburg position may have detrimental effects on both pulmonary volumes and mechanics, and they may increase the risk of postoperative respiratory failure (PORF). Continuous positive airway pressure (CPAP) improves oxygenation and reduces the rate of re-intubation in the presence of PORF.
The aim of our study is to investigate postoperative respiratory function and the likely benefits of the use of CPAP, compared with Venturi mask in terms of prevention of post-operative hypoxaemia and worsening of lung spirometry.
CPAP is delivered with "CASTAR" Helmet by StarMed.
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 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective laparoscopic prostatectomy
- •American Society of Anesthesiologists status I-II
排除标准
- •Cardiac functional status New York Heart Association (NYHA) >II
- •Chronic Obstructive Pulmonary Disease (COPD) Gold Class >2
结局指标
主要结局
Incidence of postoperative respiratory failure (PaO2<60mmHg, FEV1<70% of baseline)
时间窗: 24 hours after the end of surgery
次要结局
- Incidence of pneumonia(Partecipants will be followed for the duration of hospital stay, an expected average of 1 week)
研究者
Tommaso Fossali
Consultant
ASST Fatebenefratelli Sacco