A Randomized Comparison of Active Suction vs. Passive Chest Tube Drainage and Regulated and Unregulated Pleural Pressure After Anatomic Lung Resection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 5
- 主要终点
- Duration of air leak
研究概览
简要总结
A 2 x 2 randomized study testing active versus passive drainage and regulated versus unregulated pleural pressure in patients undergoing anatomic lung resection
详细描述
This study is a prospective, multi-center randomized clinical trial at 6 sites. Pre-operative evaluation and the decision for surgical intervention will proceed as currently performed at each center. That is, neither inclusion in nor exclusion from this study will affect the plan of care for patients other than the approach to chest tube management, which is determined by randomization among 4 methods that are in common clinical use. Each enrolled patient will be randomized to either regulated pleural pressure using the Thopaz+ digital chest drainage device or unregulated pleural pressure using a traditional system (multi-chambered system e.g. Pleur-Evac, Atrium-Maquet or similar device as is routine at each institution) and also randomized to either active suction (-20 cm H2O) or passive drainage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to read, understand, and provide written consent
- •Age 18-90
- •Undergoing a segmentectomy, lobectomy, or bilobectomy (including sleeve resection). Both open and minimally invasive (thoracoscopic or robotic) resections are acceptable
排除标准
- •Patients unstable enough to require ICU care for hemodynamic or respiratory problems during the first 7 days postoperatively. Patients admitted to the ICU for other reasons (e.g. bed availability, institutional norm, routine monitoring etc.) should NOT be excluded
- •Patients undergoing non-anatomic lung resection only (i.e. wedge resection)
- •Patients undergoing anatomic lung resection for bullous disease, lung abscess or bronchiectasis.
- •Patients undergoing pneumonectomy or completion pneumonectomy
研究组 & 干预措施
Reg pressure, Active suction (Dig)
Regulated pleural pressure with active suction
干预措施: Reg Pressure (Other)
Reg pressure, Active suction (Dig)
Regulated pleural pressure with active suction
干预措施: Active Suction (Dig) (Other)
Reg pressure, Passive drainage (Dig)
Regulated pleural pressure with passive drainage
干预措施: Reg Pressure (Other)
Reg pressure, Passive drainage (Dig)
Regulated pleural pressure with passive drainage
干预措施: Passive Drainage (Dig) (Other)
Unreg pressure, Active suction (Trad)
Unregulated pleural pressure with active suction
干预措施: Unreg Pressure (Other)
Unreg pressure, Active suction (Trad)
Unregulated pleural pressure with active suction
干预措施: Active Suction (Trad) (Other)
Unreg pressure, Passive drainage (Trad)
Unregulated pleural pressure with passive drainage
干预措施: Unreg Pressure (Other)
Unreg pressure, Passive drainage (Trad)
Unregulated pleural pressure with passive drainage
干预措施: Passive Drainage (Trad) (Other)
结局指标
主要结局
Duration of air leak
时间窗: up to 7 days
Duration until there is no clinically significant air leak by standard criteria (no bubbles during coughing with a traditional device and a ≥6 hour period with no spikes \>80 ml/min and an air flow ≤30 ml/min during passive drainage or ≤50 ml/min during active suction)
次要结局
- Time till chest tube removal(up to 7 days)