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临床试验/NCT02344524
NCT02344524已完成不适用

Drainage of Traumatic Hemothorax and Pneumothorax: Small Bore Versus Large Bore Chest Drain- a Randomized Controlled Trial

Delhi University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Success rate

研究概览

简要总结

The purpose of this trial is to study the role of small bore chest drains in draining traumatic hemothorax and pneumothorax.

详细描述

The precise role of small bore chest drains in treating post traumatic pleural collections, especially hemothorax is not well established. This trial is conducted to study the efficacy and safety profile of small bore chest drains in trauma patients with hemothorax and pneumothorax.

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
16 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with traumatic hemothorax, pneumothorax and hemopneumothorax

排除标准

  • Patients with tension pneumothorax
  • Patients requiring emergency thoracotomy
  • Patients who had undergone chest drain insertion elsewhere
  • Patients lost to follow up

研究组 & 干预措施

Small bore chest drain

Experimental

Intercostal drainage for traumatic hemothorax and pneumothorax using small bore chest drain

干预措施: Intercostal drainage (Device)

Large bore chest drain

Active Comparator

Intercostal drainage for traumatic hemothorax and pneumothorax using large bore chest drain

干预措施: Intercostal drainage (Device)

结局指标

主要结局

Success rate

时间窗: 7 days (plus or minus 5 days)

Complete drainage of traumatic hemothorax and pneumothorax

次要结局

  • Procedure time(At the time of the intervention)
  • Iatrogenic injuries(At the time of the intervention)
  • Resolution time(7 days (plus or minus 5 days))
  • Wound healing time(10 days (plus or minus 5 days))
  • Catheter sepsis(7 days (plus or minus 5 days))

研究者

发起方
Delhi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sunil Kumar

Director Professor & Head, Department of Surgery

Delhi University

研究点 (2)

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