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临床试验/NCT00575198
NCT00575198已完成不适用

Non-inferiority Randomized Trial Evaluating Removal of Thoracostomy Tubes Independent of the Drainage Amount Versus Removal When the Drainage Amount Is Low

University of California, Davis2 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2007年12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
280
试验地点
2
主要终点
Invasive drainage procedure

研究概览

简要总结

The purpose of this study is to determine whether chest tubes can be safely removed without considering how much fluid is draining through the tube.

详细描述

Thoracostomy tubes are routinely used to drain the pleural space of fluid and gas to optimize pulmonary mechanics. Clinicians frequently postpone removal of thoracostomy tubes if the drainage from the tube exceeds a specific volume threshold for the prior 24 hours. However, there is substantial variability in the drainage volume threshold that different clinicians use, and no threshold has been established as clearly superior to any other. Removing tubes independently of the drainage volume may result in a greater risk of pleural effusion or pneumothorax requiring an invasive drainage procedure. However, removing tubes independently of the drainage volume might also expedite recovery by allowing earlier removal of the tube, thus diminishing pain and increasing patient mobility.

Thoracostomy tube management practices, including the drainage volume threshold used, may be dissimilar for different types of disease processes, so this study will be restricted to patients who required a thoracostomy tube for treatment of traumatic injury.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Thoracostomy tube in place for <72 hours
  • Age at least 14 years
  • Hospitalized for traumatic injury or elective operation

排除标准

  • Thoracostomy tube already removed from the pleural cavity of interest
  • Mediastinal tubes
  • Death expected within 48 hours
  • Prisoner status
  • Severe congestive heart failure
  • End-stage liver disease
  • End-stage renal disease
  • History of or suspected empyema involving the pleural cavity of interest
  • History of or anticipated need for pleurodesis of the pleural cavity of interest
  • Malignant pleural effusion
  • Pregnancy
  • Previous participation in this study
  • Thoracostomy tube drainage already <2 mL/kg

结局指标

主要结局

Invasive drainage procedure

时间窗: Within 60 days

次要结局

  • Time to thoracostomy tube removal(Within 60 days)
  • Mortality(60 days)
  • Pulmonary symptoms(60 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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