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