A Comparative Study of Incentive Spirometry and Positive Expiratory Pressure in Patients With Chest Trauma: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Improve the degree of pain
研究概览
简要总结
Chest trauma (CT) patients with 3 or more ribs fractures with or without pleuropulmonary injury are an indicator of severity. Chest physiotherapy (CP) and analgesia is the first line treatment in these patients.
The aim study is to evaluate the effect of positive expiratory pressure (PEP) breathing compared to the incentive spirometry in terms of pain control in the recent phase of CT.
详细描述
After acceptance to participate in the study, patients will be computerized randomized into 2 groups:
- PEP group: positive expiratory pressure (PEP) breathing.
- INS group: inspiratory incentive spirometry breathing. The period between day 0 and 20 days post-trauma is considered an immediate phase of TT.
Once admitted, an initial evaluation by the doctor will be performed, and pleuro-pulmonary complications, the presence of respiratory failure, and pain control will be evaluated. The CP will perform a clinical, pain control, secretion and a dynamic costal examination. The medical treatment of pain control will begin, and the treatment of CP will begin, where it will be randomized in 2 groups: 1- PEP group: positive expiratory pressure (PEP) breathing the help of a PEP bottle device. 2- INS group: inspiratory incentive spirometry device (Coach®). Will be daily FR sessions, on weekdays. Upon admission, hospital discharge and post-discharge, radiological checks (simple radiography) will be performed and forced vital capacity will be measured with forced spirometry.
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
- Single (Outcomes Assessor)
盲法说明
Los evaluadores de los resultados y el investigador que realiza la aleatorización
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chest trauma of 3 or more rib fractures with or without hemopneumothorax
- •Signed informed consent.
排除标准
- •Non-collaborating patients.
- •Failure to submit a duly completed follow-up sheet for carrying out a minimum daily guideline (3 times a day) for CP treatment.
- •Presence of respiratory failure at admission: PaO2 <60mmHg and / or PaCO2> 50mmHg.
- •Medical indication for invasive or non-invasive ventilatory support.
- •Presence of undrained pneumothorax.
- •Complications that limit early mobility.
结局指标
主要结局
Improve the degree of pain
时间窗: 1 month
To assess if PEP decreased pain
次要结局
- Resolution of pleural lesions(1 month)
- Improve lung function(1 month)
- Reduce hospital stay(1 month)