The Role of Clamping Before Removal of a Pneumothorax Drain Connected to a Digital Drainage System.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Isala
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Recurrent pneumothorax after chest tube removal
研究概览
简要总结
The study will be conducted as a, prospective, open label, non-inferiority, randomized controlled trial. In the intervention group; chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data. In the control group removal will be determined by the same criteria of the digital drainage system but before removal, a chest tube clamping test will be performed. Primary outcome measure: recurrent pneumothorax after chest tube removal requiring chest tube reinsertion
详细描述
Determining and timing of chest tube removal has been a continuous topic of debate amongst both surgeons and pulmonologist. It is plausible that provocative clamping tests are no longer necessary when a digital continuous recording drainage device is used that demonstrates the absence of (intermittent) air leak. However, clamping trials are still performed in clinical care, it is an expert opinion's policy prompted by fear of recurrent pneumothorax and no comparative studies exist. We hypothesize that chest tube removal exclusively based on digital drainage system data is as safe as adding a clamping test before removal in patients treated for pneumothorax or after lung surgery.
The study will be conducted as a, prospective, open label, non-inferiority, randomized controlled trial. In the intervention group; chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data. In the control group removal will be determined by the same criteria of the digital drainage system but before removal, a chest tube clamping test will be performed.
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
- •Digital chest tube drainage system
- •Pneumothorax (primary, secondary, pulmonary surgery)
排除标准
- •Pleural effusion as primary indication for chest tube placement.
- •Suspected chest tube malfunction (e.g., leaking, occlusion, malposition)
- •Intubated during chest tube removal
结局指标
主要结局
Recurrent pneumothorax after chest tube removal
时间窗: 0-24 hours after drain removal
number of patients requiring chest tube reinsertion within 24 hours after chest tube removal for recurrent pneumothorax
次要结局
未报告次要终点
