A randomized control trial comparing the efficacy of small-bore 14-French (14Fr) pigtail catheters versus 28-32Fr chest tubes in management of traumatic hemothorax & hemopneumothorax.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Failure rates of drainage catheters, requiring change of the tube.
研究概览
简要总结
This trial is to compare 14 French pigtail catheter (new treatment) versus the usual recommended treatment with 28 to 32 French chest tubes in case of traumatic hemothorax or hemopneumothorax. A few studies have shown that 14 French pigtail catheter was equally efficacious in draining hemothorax or hemopneumothorax in case of blunt chest trauma as that of 28 to 32 French chest tubes. The benefit of using 14 French pigtail catheters is that they are small bore catheters, associated with lesser pain and better patient comfort, while being equivalent to the wide bore chest tubes, which is recommendations by ATLS. Thus we aim to compare the efficacy of 14 French pigtail catheters in terms of failure rates, versus 28 to 32 French chest tubes in draining traumatic hemothorax or hemopneumothorax in blunt chest trauma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Age more than 18 years
- •Blunt chest trauma
- •Any isolated chest injury or polytrauma with traumatic hemothorax or hemopneumothorax requiring drainage (more than 300 mL on CT scan thorax.
- •However, not all patients would receive computed tomography scans quantifying this amount when it is obvious on chest xray or ultrasonography).
排除标准
- •Penetrating chest trauma
- •Chest drain insertion more than24 hours after the trauma
- •Isolated pneumothorax
- •Placement of the chest drain was primarily for drainage of pneumothorax in the hemopneumothorax.
- •Pregnant patients
- •Death on arrival.
结局指标
主要结局
Failure rates of drainage catheters, requiring change of the tube.
时间窗: 12 hours, 24 hours
次要结局
- Total drain output
- Pain score assessment using Numerical Rating Scale (NRS) at the tube site
- Tube related complications.(48 hours)
- Total tube days(10 days)
- Total ventilator days.(Intensive care unit (ICU) & hospital length of stay (HLOS).)
研究者
Anjali Rangnani
Christian Medical College, Vellore