The impact of low pressure negative pleural suction versus underwater seal drainage in patient of thoracic trauma: A randomised controlled study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- To establish the benefits of chest tube use with negative pleural suction compared with the underwater seal drainage system in patients with thoracic trauma.
研究概览
简要总结
Thoracic trauma affects approximately 60% of patients with multiple injuries and is responsible for 20% to 25% of trauma-related deaths.
Types of thoracic trauma:-
-
hemopneumothorax (52.3%), most common
-
hemothorax (23.4%) and
-
pneumothorax (20-20.7%)
For most of the patients of thoracic trauma requires only the placement of a chest tube connected to a underwater seal drainage system
Downside of ICD:- despite of ICD, complication such as persistent air leak, clotted hemothorax, and empyema.
These complications increase morbidity, the need for more complex surgeries, hospital stay, and health-related costs.
Low pressure negative pleural suction:- For inducing pleural attachment and promoting the quick closing of air leaks and hemothorax drainage.
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
- 15.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients more than 15 years of age.
- •Patients who diagnosed with traumatic pneumothorax, hemothorax or hemopneumothorax (penetrating or blunt) will be enrolled.
排除标准
- •Not giving consent
- •Patients with history of pulmonary diseases or heart failure chronic pulmonary diseases (chronic obstructive pulmonary disease, diffuse interstitial lung disease)
- •Active tuberculosis
- •Patients with multiple injuries with severe traumatic brain injury (TBI) and Glasgow Coma Scale score less than 8 of 15.
结局指标
主要结局
To establish the benefits of chest tube use with negative pleural suction compared with the underwater seal drainage system in patients with thoracic trauma.
时间窗: Outcomes will be accessed clinically and radiologically every 24 hourly.
次要结局
- 1. To study the incidence of complications, such as persistent air leak, coagulated hemothorax, empyema, recurrent pneumothorax.(2.To study the length of hospitalization)
研究者
Dr Shahnawaz Ahmad
King George Medical University, Lucknow India