Safety and Efficacy of Coaxial Smart Drain (Redax TM) in Uniportal-VATS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 2
- 主要终点
- Fluid output 2
研究概览
简要总结
The aim of the study is to evaluate efficacy and safety of "Smart Coaxial drain" (Redax TM, Poggio Rusco, Mantova, Italia) in terms of total amount of effusion drained, incidence of residual effusion at Chest X-Ray and patient's comfort in Uniportal- and Biportal-VATS upper lobectomies.
In particular, to evaluate in Uniportal-VATS upper lobectomies the efficacy and safety of smart coaxial drains compared with standard silicone chest tubes.
详细描述
At the end of lung surgery, usually surgeons placed one or more chest tubes. There are several types of chest tubes and the type used by surgeons depends on centre avaiability/ local practice or surgeon choice etc...Coaxial smart drains are used in clinical practice since several years in Thoracic Surgery. In thoracoscopic (VATS) surgery usually only one chest tube is placed. In this study, we evaluate the efficacy of placement of 28Fr "coaxial smart drain" chest tube versus 28 Fr standard chest tube after Uniportal- or Biportal-VATS upper lobectomies in terms of total amount of effusion drained, incidence of residual effusion at Chest X-Ray and patient's confort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Patients undergone upper right or left lobectomy in Uniportal- or Biportal-VATS
排除标准
- •Patients undergone open surgery
- •Patients undergone middle or lower lobectomies
- •Patients undergone chest wall/or wedge resections
研究组 & 干预措施
Study group 1
All patients undergone Uniportal-VATS upper lobectomy with standard 28Fr chest drain placed at the end of surgery
Study group
All patients undergone Uniportal-VATS upper lobectomy with 28Fr Smart Coaxial drain placed at the end of surgery
干预措施: 28Fr "coaxial smart drain" chest tube (Procedure)
Study group 2
All patients undergone Biportal-VATS upper lobectomy with 28Fr Smart Coaxial drain placed at the end of surgery
干预措施: 28Fr "coaxial smart drain" chest tube (Procedure)
结局指标
主要结局
Fluid output 2
时间窗: At 48 hours from surgery
Total fluid amount
Fluid output 3
时间窗: At 72 hours from surgery
Total fluid amount
Fluid output 4
时间窗: At 96 hours from surgery
Total fluid amount
Fluid output 1
时间窗: At 24 hours from surgery
Total fluid amount
Residual pleural effusion at chest X-Ray
时间窗: 72 hours after surgery
Residual pleural effusion at chest X-Ray before chest tube removal. The entity of pleural effusion is measured as "intercostal spaces", counted on posterior costal arches
subcutaneous emphysema 3
时间窗: At 72 hours after surgery
incidence of subcutaneous emphysema
subcutaneous emphysema 1
时间窗: At 24 hours after surgery
incidence of subcutaneous emphysema
subcutaneous emphysema 2
时间窗: At 48 hours after surgery
incidence of subcutaneous emphysema
次要结局
- Pain related to chest tube 4(At 96 hours after surgery)
- Tube obstruction(during chest tube removal procedure)
- Pain related to chest tube 1(At 24 hours after surgery)
- Pain related to chest tube 3(At 72 hours after surgery)
- Pain related to chest tube 2(At 48 hours after surgery)