Omission of Chest Tube Versus Improved Drainage Strategy in Patients With Lung Wedge Resection: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 主要终点
- The incidence rate of massive pneumothorax on day 1 after surgery
研究概览
简要总结
This study evaluates the viability and safety of two-lumen catheterization versus complete omission of chest tube in patients with lung wedge resection. Half of participants will receive complete omission of chest tube, while the other half will receive a two-lumen central venous catheterization along the midclavicular line, second intercostal space for remedial gas-remove.
详细描述
With the development of video-assisted thoracoscopic surgery (VATS) techniques, minimally invasive thoracic surgery has evolved considerably over the last three decades. The concept of "tubeless" involves non-intubated anesthesia with spontaneous ventilation and no chest tube placement. Chest tube placement always causes pain, and its duration is known to be one of the most important factors influencing hospital stay and costs. Early tube removal allows patients to breathe deeply with less pain, which leads to more compliance with chest physiotherapy, as demonstrated by a concomitant improvement in patients' ventilatory function. Hence, more and more experienced surgeons choose the omission of chest tube placement after lung wedge resection. However, based on previous retrospective studies, residual pneumothorax was noted in about 10% cases, and some of them need re-intervention. Hence, the investigators designed a intra-operative two-lumen catheterization as improved drainage strategy. Therefore, this study evaluates the viability and safety of two-lumen catheterization versus omission of chest tube placement in patients with lung wedge resection.
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
- •Preoperative radiology revealed solitary peripheral pulmonary nodule, with both size and depth less than 3 cm
- •Lung wedge resection for tumor biopsy to elucidate drug resistant mechanism or confirm diagnosis
排除标准
- •Previous ipsilateral thoracic surgery or extensive adhesion
- •Preoperative radiology revealed pneumonia or atelectasis
- •Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- •Bleeding tendency or anticoagulant use
- •Pregnancy or breast feeding
- •Patient who can not sign permit
结局指标
主要结局
The incidence rate of massive pneumothorax on day 1 after surgery
时间窗: 1 day
To evaluate the incidence rate of pneumothorax (a pneumothorax greater than 2.0 cm on X-ray)
次要结局
- Pain score on day 1 after surgery(1 day)
- Length of post-operative hospital stay(1 week)
- Postoperative pulmonary function recovery(1 month)
研究者
Wen-zhao ZHONG
Porfessor
Guangdong Provincial People's Hospital