Drainage Amount for Removal of Thoracostomy Tube (DARTT)
Non-inferiority Randomized Trial Evaluating Removal of Thoracostomy Tubes Independent of the Drainage Amount Versus Removal When the Drainage Amount Is Low
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
California
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Sacramento、California、美国、95817
- University of California, Davis, Medical Center
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Thoracostomy tube in place for <72 hours
- Age at least 14 years
- Hospitalized for traumatic injury or elective operation
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:1
No drainage threshold
|
Removal of the thoracostomy tube independently of the amount of fluid that drained from the tube in the prior 24 hours
|
|
有源比较器:2
Drainage <2 mL/kg
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Removal of the thoracostomy tube only if the drainage from the tube in the prior 24 hours is less than 2 mL/kg of the patient's ideal body weight
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Invasive drainage procedure
大体时间:Within 60 days
|
Within 60 days
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
死亡
大体时间:60天
|
60天
|
|
Time to thoracostomy tube removal
大体时间:Within 60 days
|
Within 60 days
|
|
Pulmonary symptoms
大体时间:60 days
|
60 days
|
合作者和调查者
调查人员
- 首席研究员:Garth H Utter, MD MSc、University of California, Davis
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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