NCT04986527撤回不适用
Chest Tube Management in Traumatic Pneumothorax: Does Duration of Suction Matter
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Chest tube dwell time
研究概览
简要总结
The purpose of this pilot study is to determine whether chest tube suction duration, 24 hours vs 48 hours, prior to water seal affects outcome and length of stay after placement for traumatic 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Trauma service consult/patient
- •Traumatic pneumothorax with chest tube placed within 0-24 hours of presentation and confirmation of adequate position
- •Blunt or penetrating mechanism
- •Chest tubes sizes 14 to 32Fr
- •Chest tubes placed by residents on the trauma surgery service supervised by attending trauma surgeons or placed by the attending surgeon themselves
- •Presence of single chest tube in one or both pleural cavities (single unilateral or bilateral tubes)
- •Subjects with decision making capacity (DMC) who are able to provide written consent. DMC will be determined by the consenting physician through a teach back mechanism. Subjects must demonstrate understanding of the situation, appreciation of the consequences of their decision, reasoning of their thought process, and be able to communicate their wishes.
排除标准
- •Pregnant patients
- •Prisoners
- •Mechanically ventilated in ICU for more than 24 hours while chest tube in place
- •Chest tubes placed as part of, or present during, a thoracic operation
- •History of surgery involving pleural cavity ipsilateral to chest tube
- •Subjects with more than one chest tube on the ipsilateral side at any time prior to study chest tube removal
- •Subjects with chylothorax or empyema
- •Subjects with chest tubes that are withdrawn or removed unintentionally
- •Subjects with known or suspected bronchial injury
- •Subjects with bullous emphysema.
结局指标
主要结局
Chest tube dwell time
时间窗: up to 1 month
Total time that chest tube is in place from insertion to removal
次要结局
- Transfer to ICU(up to 1 week)
- Number of participants with at least one pulmonary complications(up to 1 week)
- Readmission to hospital(30 days)
- Number of participants with reaccumulation of pneumothorax(up to 3 days)
- Median length of stay(Up to 1 year)
研究者
Michael J Nabozny, MD
Assistant Professor
University of Rochester
研究点 (2)
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