Does the Addition of Positive Expiratory Pressure (PEP) Mask Therapy to Usual Medical Care Improve Patients' Symptoms, Quality or Life and Risk of Future Exacerbations in Individuals With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 4
- 主要终点
- Symptom severity
研究概览
简要总结
This study aims to identify whether the addition of positive expiratory pressure (PEP) mask therapy to standard medical care improves clinically important outcomes in individuals with acute exacerbations of chronic obstructive pulmonary disease. It is hypothesized that those who receive the additional PEP mask therapy will show greater improvements than those who do not.
详细描述
This study aims to identify whether the addition of positive expiratory pressure (PEP) mask therapy to standard medical care improves symptoms, quality of life and risk of re-exacerbation in individuals with acute exacerbations of chronic obstructive pulmonary disease.
A PEP mask is a small hand-held device that is self-applied over the nose and mouth. It creates a resistance against exhalation (outward) breaths which helps facilitate movement of sputum from the lungs towards the mouth.
Participants will be recruited from two tertiary metropolitan hospitals in Melbourne, Australia and randomised to receive either 'usual care' (comprising medical management, non-invasive ventilation if required, rehabilitation and allied health interventions) or 'usual care' plus PEP mask therapy for the duration of their hospital admission. All participants will then complete daily diaries for six months after discharge.
The effect of PEP mask therapy will be evaluated using a range of outcomes important to both patients and health care providers.
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)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Symptom severity
时间窗: 6 months following hospital discharge
Measured via the BCSS
次要结局
- Number of acute exacerbations(6 months following hospital discharge)
- Total number of hospitalised days(6 months following hospital discharge)
- Mortality (predicted)(6 months following hospital discharge)
- Number of hospitalisations (due to respiratory illness)(6 months following hospital discharge)
- Mortality (actual, all cause)(6 months following hospital discharge)
- Lung function (spirometry)(6 months following hospital discharge)
- Time to first exacerbation(6 months following hospital discharge)
- Time to first hospitalisation (due to respiratory illness)(6 months following hospital discharge)
- Disease-specific quality of life(6 months following hospital discharge)
- Need for assisted (non-invasive and/or invasive) ventilation during hospitalisation (within, and after 48 hours of presentation to hospital)(At hospital discharge (up to approx. day 10))
- Hospital length of stay(At hospital discharge (up to approx. day 10))
研究者
Christian Osadnik
Physiotherapist, PhD candidate
La Trobe University