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临床试验/NCT01864577
NCT01864577已完成不适用

Efficacy of Negative Pleural Suction in Tube Thoracostomy for Patients With Penetrating and/or Blunt Chest Trauma: a Randomized Clinical Trial

Universidad de Antioquia1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
Lenght of Hospital stay

研究概览

简要总结

The purpose of this study is to determine whether the use of negative pleural suction in tube thoracostomy is more effective than water seal alone for the treatment of pneumothorax and/or hemothorax in patients with chest trauma.

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
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pneumothorax after penetrating o blunt chest trauma
  • Hemothorax after penetrating o blunt chest trauma
  • Hemopneumothorax after penetrating o blunt chest trauma
  • Require tube thoracostomy

排除标准

  • Invasive mechanical ventilation
  • Emergent Surgery (thoracoscopy, open thoracotomy)
  • Chronic pulmonary diseases (COPD, CRPD)
  • Severe traumatic brain injury
  • Glasgow coma scale upon arrival <8/15

结局指标

主要结局

Lenght of Hospital stay

时间窗: 30 days

次要结局

  • Incidence of persistent bronchopleural fistulae(30 days)
  • Incidence of coagulated Hemothorax(30 days)
  • Incidence of empyema(30 days)
  • Incidence of recurrent pneumothorax(30 days)
  • Number of patients necessitating surgical interventions (includes new thoracostomy, thoracoscopy and open thoracotomy)(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Camila Mejia

Surgical Resident

Universidad de Antioquia

研究点 (1)

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