Two-Lumen Catheterization Versus Chest Tube Placement in Patients With Lung Wedge Resection: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Postoperative adverse event incidence rate
研究概览
简要总结
This study evaluates the viability and safety of two-lumen catheterization versus chest tube placement in patients with lung wedge resection. Half of participants will receive routine chest tube placement, 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 10~40% cases, and some of them need re-intervention. Hence, the investigators designed a intra-operative two-lumen catheterization for remedial gas-remove. Therefore, this study evaluates the viability and safety of two-lumen catheterization versus 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
- 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
- •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
研究组 & 干预措施
chest tube
VATS with chest tube placement
干预措施: chest tube (Procedure)
two-lumen catheter
VATS with two-lumen catheterization
干预措施: two-lumen catheterization (Procedure)
two-lumen catheter
VATS with two-lumen catheterization
干预措施: two-lumen catheter (Device)
结局指标
主要结局
Postoperative adverse event incidence rate
时间窗: 1 months
To evaluate the incidence rate of pneumothorax (a pneumothorax greater than 2.0 cm on X-ray) or pleural effusion (\>800ml) in both groups.
Rate of post-operative related complications
时间窗: 1 week
To evaluate the rate of post-operative related complications within 7 days of surgery
Length of post-operative hospital stay
时间窗: 1 week
To evaluate the length of post-operative hospital stay
次要结局
- The time of post-operative extubation(1 week)
- Postoperative pulmonary function recovery(1 week)
- Postoperative wound satisfaction(1 month)
- Postoperative pneumoderm incidence rate(3 days)
- Postoperative pain score(1 day)
研究者
Wen-zhao ZHONG
Guangdong General Hospital
Guangdong Provincial People's Hospital