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临床试验/NCT03724721
NCT03724721已完成不适用

To Investigate the Safety and Efficacy of Vacuum Bottle Plus Catheter for Drainage of Pneumothorax

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2018年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Intrapleural pressure during vacuum bottle air drainage

研究概览

简要总结

The use of vacuum bottle in drainage of pneumothorax was seldom reported. This study aims to investigate the safety of vacuum bottle plus non-tunneled catheter for drainage of iatrogenic pneumothorax.

详细描述

For aspiration or drainage of pneumothorax, a 16-gauge or 18-gauge over-the-needle non-tunneled catheter, a pigtail, or chest tube are frequently used to penetrate the pleural space. A 50-ml or 60-ml syringe may be connected to the over-the-needle catheter or a pigtail for simple aspiration, while underwater-sealed bottle or suction drainage connected to chest tube for drainage of pneumothorax. Vacuum bottle for removing pleural effusion are frequently reported in literature and common in daily practice. However, the use of vacuum bottle in drainage of pneumothorax was seldom reported. This study aims to investigate the safety of vacuum bottle plus non-tunneled catheter for drainage of iatrogenic pneumothorax.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Intrapleural pressure during vacuum bottle air drainage

时间窗: Within 1 hour

The investigator will measure the intrapleural pressure during air drainage at 5 seconds, 10 seconds, 15 seconds, 20 seconds, 25 seconds, 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes and until finished (the remaining with 5 minutes interval). It is proposed in previous studies that it is safe if the intrapleural pressure is less than 20 cmH2O during the procedure.

次要结局

  • Rate of reexpansion pulmonary edema(within 1day after the procedure)
  • The resolution rate of pneumothorax(1 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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