Suction Versus Water Seal for Initial Treatment of Traumatic Pneumothorax Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Chest tube duration
研究概览
简要总结
The goal of this clinical trial is to compare the effect of placing chest tubes to water seal versus suction initially, in patients with traumatic pneumothoraces, on overall chest tube duration.
The main question it aims to answer is:
- Does placing chest tubes to water seal initially results in a shorter chest tube duration, without an increase in complications?
Alternating each month, patients' chest tubes will either be placed to water seal or to suction initially. All other management decisions related to the chest tube will be left to the providers.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •admitted to the trauma surgery service
- •pneumothorax requiring a chest tube
排除标准
- •less than 18 years olf
- •greater than 300cc of hemothorax on CT
- •chest tube placed prior to CT scan
研究组 & 干预措施
Initial Water Seal
After chest tube placement, the chest tube will be placed to 20cm H2O of suction for 1 minute to evacuate all pneumothorax. After this, the chest tube will be placed to water seal, defined as the water seal chamber on the chest tube drainage system being filled up to the 2cm line and not on suction. All other management decisions related to the chest tube will be left to the providers.
干预措施: Inital water seal (Procedure)
Initial Suction
After chest tube placement, the suction group will have their chest tube placed to 20cm H2O of suction delivered by the chest tube drainage suction. All other management decisions related to the chest tube will be left to the providers.
干预措施: Initial suction (Procedure)
结局指标
主要结局
Chest tube duration
时间窗: Through study completion, an average of 1 year
Duration of the initial chest tube, measured in hours
次要结局
- Unplanned ICU admission(Through study completion, an average of 1 year)
- Change from water seal to suction(Through study completion, an average of 1 year)
- Additional chest tube placement on affected side(Through study completion, an average of 1 year)
- Pneumothorax reaccumulation with chest tube to water seal(Through study completion, an average of 1 year)
- Replacement of chest tube(Through study completion, an average of 1 year)
- Pneumothorax reaccumulation after chest tube removal(Through study completion, an average of 1 year)
- Hypoxic events(Through study completion, an average of 1 year)
- Empyema(Through study completion, an average of 1 year)
- Pneumonia(Through study completion, an average of 1 year)
- Retained hemothorax(Through study completion, an average of 1 year)
- TPA administration(Through study completion, an average of 1 year)
- Chest tube site, skin and soft tissue infection(Through study completion, an average of 1 year)
- Video-assisted thoracoscopic surgery(Through study completion, an average of 1 year)
- Acute respiratory failure requiring intubation(Through study completion, an average of 1 year)
- 30-day mortality(Through study completion, an average of 1 year)
- Length of hospital stay(Through study completion, an average of 1 year)
- 30-day readmission(Through study completion, an average of 1 year)
- Thoracic intervention during readmission(Through study completion, an average of 1 year)
研究者
Eric Yeates
Acute Care surgery Clinical Fellow
Vanderbilt University Medical Center