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临床试验/NCT04548466
NCT04548466已完成不适用

Effect of Positive Expiratory Pressure on the Management of Chest Trauma: a Randomized Controlled Trial

Hospital de Granollers2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Aid secretion clearance

研究概览

简要总结

Chest trauma (CT) are a common problem in our environment caused mainly by traffic accidents and causal and domestic accidents among the elderly population. CTs, in some situations, can lead to sequelae such as fibrothorax secondary to hemothorax and / or empyema and residual chronic pain. Clinical regulations and guidelines recommend a guideline for chest physiotherapy (CP) for all patients with rib fractures, but there is little scientific evidence. It would be interesting to establish CP treatment protocols and describe the most appropriate techniques according to the type and stages of thoracic trauma consolidation.

Objective: To evaluate the effect of Positive Expiratory Pressure (PEP) breathing added to conventional CP in terms of aid secretion clearance, pain control, pleuropulmonary radiological abnormalities, restoration of lung function, and admission days in the immediate phase of the 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 breathing.
  • CONTROL group: conventional CP treatment without positive pressure brething. The period between day 0 and 20 days post-trauma is considered an immediate phase of CT.

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 chest physiotherapist will perform a clinical and secretion assessment using the Seva test 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 breathing with the help of a PEP bottle device. 2-CONTROL group: conventional CP treatment without positive pressure breathing 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
None

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

入选标准

  • Chest trauma with three or more rib fractures with or without hemopneumothorax
  • Failure to meet any

排除标准

  • Exclusion Criteria:
  • Non-cooperative patients for not understanding chest physiotherapy techniques.
  • Presence of respiratory failure on admission: PaO2 <60mmHg i / or PaCO2> 50mmHg.
  • Medical indication for mechanical ventilation or non-invasive ventilatory support.
  • Presence of undrained pneumothorax.
  • Complications that limit early mobility.

结局指标

主要结局

Aid secretion clearance

时间窗: 1 month

To determine if PEP bottle improves the secretion clearance

次要结局

  • Reduce hospital stay(1 month)
  • Resolution of pleural lesions(1 month)
  • Improve lung function(1 month)

研究者

发起方
Hospital de Granollers
申办方类型
Other
责任方
Sponsor

研究点 (2)

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