The NoTube Study: Evaluation of the Necessity of a Chest Tube After a Video-assisted Thoracoscopic Surgery Pulmonary Wedge Resection.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Pneumothorax >10% / Hemothorax
研究概览
简要总结
After performing VATS pulmonary wedge resections, a chest tube is routinely left in the pleural cavity to drain possible air leaks and fluid accumulations. Chest tubes after VATS pulmonary wedge resections are left in place a minimum of 1 day. However, this practice has no scientific foundations. The investigators believe it is possible to avoid the placement of a chest tube after this procedure in a great amount of patients. This is a randomized controlled clinical trial with analysis blinding in which the investigators want to compare the outcomes between installing a chest tube or not after VATS pulmonary wedge resections. The investigators will include consecutively patients with interstitial lung disease or indeterminate pulmonary nodules undergoing this procedure, at the participating institutions. The investigators calculated a sample size of 50 subjects in each group using pneumothorax < 10% data from Luckraz et al and to determine a difference of hospital stay of 2 versus 1 day; DS(1.5), power = 0.9 and alpha = 0.05.
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
- Single (Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing video-assisted thoracoscopic surgery pulmonary wedge resections at the participating institutions.
- •No evidence of air leak at the end of the surgical procedure.
- •No active bleeding at the end of the surgical procedure.
排除标准
- •Pleural effusion previous to the procedure requiring drainage after it.
- •Bullous or emphysematous changes in lung parenchyma.
- •Patients going to positive pressure in the airways after the procedure.
结局指标
主要结局
Pneumothorax >10% / Hemothorax
时间窗: 1 hour and 1-5 days postoperatively
次要结局
- Pain (Visual analogue scale)(At days 1-5 of hospitalization and at 1 month)
- Surgical procedure duration(At the end of surgery)
- Hospital stay(At patient discharge)