Comparison of the Outcome of Thoracic Cavity Irrigation Versus No Irrigation in Patients of Traumatic Hemothorax Undergoing Tube Thoracostomy: A Randomized Controlled Trial.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Incidence of retained hemothorax requiring secondary interventions such as VATS, thrombolysis, or additional tube thoracostomy.
研究概览
简要总结
The proposed dissertation is a randomized controlled trial evaluating the effectiveness of thoracic cavity irrigation versus no irrigation during tube thoracostomy in patients with traumatic hemothorax. Traumatic hemothorax is a frequent consequence of thoracic trauma and, if inadequately drained, can lead to retained hemothorax and severe complications like empyema, fibrothorax, and the need for secondary interventions such as video-assisted thoracoscopic surgery (VATS). While systematic reviews and observational studies suggest that thoracic irrigation may significantly reduce these complications, there is a paucity of randomized trials, especially in the Indian context where trauma burden is high and access to advanced interventions is often limited.
This study aims to generate robust evidence on the clinical benefits of thoracic irrigation, particularly its ability to reduce retained hemothorax, minimize secondary interventions, shorten hospital stays, and lower healthcare costs. The trial holds particular relevance for resource-constrained settings like rural India and seeks to establish thoracic irrigation as a cost-effective, scalable intervention. The research question addresses whether thoracic irrigation improves patient outcomes compared to no irrigation, and the hypothesis posits that it will lead to significantly better clinical results. The primary objective is to compare the rate of secondary interventions between the two groups, while secondary objectives include evaluating the incidence of retained hemothorax, hospital stay duration, and complication rates. The findings are expected to influence clinical guidelines and improve trauma care practices in both high- and low-resource healthcare systems.
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 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Adults aged 18 years or older with confirmed traumatic hemothorax requiring tube thoracostomy.
- •Patients presenting within 24 hours of injury during the study period.
- •Patients who provide written informed consent to participate in the study.
排除标准
- •Patients requiring immediate thoracotomy or video-assisted thoracoscopic surgery (VATS).
- •Isolated pneumothorax without evidence of hemothorax.
- •Tube thoracostomy performed more than 24 hours after the initial trauma.
- •Hemodynamically unstable patients requiring emergency surgical intervention.
- •Patients who had thoracostomy tube placement at another institution prior to transfer.
- •Patients whose thoracostomy tube is removed within 24 hours of placement.
- •Patients who die within 48 hours of hospital admission.
- •Patients younger than 18 years of age.
- •Patients who refuse consent to participate in the study.
结局指标
主要结局
Incidence of retained hemothorax requiring secondary interventions such as VATS, thrombolysis, or additional tube thoracostomy.
时间窗: at 1 week, 2 weeks, 30 days
次要结局
- i. Incidence of retained hemothorax between the two groups.(ii. Duration of hospital stay.)
研究者
Jeeshan Khan
All India Institute of Medical Science Patna
