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
- 2
- 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
- •(all of the following criteria must be met):
- •The primary reason for hospital admission is an acute exacerbation of clinically diagnosed COPD
- •There is evidence of sputum expectoration or they are a chronic sputum producer ('regularly expectorates sputum on most days')
- •They are able and willing to provide written, informed consent
- •Recent (within the last 6 months) lung function data indicates obstructive lung disease (of any severity), according to the GOLD criteria: post-bronchodilator FEV1/FVC < 0.7 (only if available)
- •They have a smoking history of ≥ 10 pack/years (only if diagnosis unclear)
排除标准
- •(none of the following criteria must be present):
- •They are breathing via an artificial airway (e.g. endotracheal or tracheostomy tube)
- •They have a more significant respiratory disease other than COPD (e.g. primary diagnosis of bronchiectasis, cystic fibrosis, interstitial lung disease, asthma, lung cancer)
- •They have had recent (within the last 6 months) lung volume reduction procedure(s) (e.g. surgery, valve or stent insertion, or other), lung transplantation or pneumonectomy
- •The intervention is contraindicated (including but not limited to evidence of undrained pneumothorax, significant frank haemoptysis, recent facial, oral, oesophageal or skull surgery/trauma, altered conscious state or inability to co-operate)
- •They have poor oxygen saturation at rest (SpO2 < 88%) despite supplemental oxygen delivered via nasal prongs
- •They intend to continue performing established ACT routines throughout the study period
- •It is more than 48 hours since being admitted as an inpatient to hospital.
研究组 & 干预措施
'Usual care'
Participants will receive 'usual medical care' consisting of the following:
- Medical management: Bronchodilators, corticosteroids, antibiotics and supplemental oxygen will be provided (where appropriate) in accordance with Australian and New Zealand COPD management guidelines (COPDX guidelines).
- Non-invasive ventilation: if clinically indicated and prescribed in accordance with standardised hospital guidelines.
- Physical rehabilitation: Participants will be assessed by a physiotherapist and prescribed appropriate exercises to facilitate a safe and timely discharge. Participants will perform physical rehabilitation according to a standardised protocol with an aim of maximising physical function at discharge.
- Other allied health (e.g. occupational therapy, speech pathology, dietician) assessments and interventions, as required.
'Usual care' plus PEP mask therapy
This will comprise:
- 'Usual care'
- PEP mask therapy
干预措施: Positive expiratory pressure (PEP) mask therapy (Device)
结局指标
主要结局
Symptom severity
时间窗: 6 months following hospital discharge
Measured via the BCSS
Symptom severity
时间窗: Within 48 hours of presenting to hospital (day 1)
Measured via the Breathlessness, Cough and Sputum Scale (BCSS).
Symptom severity
时间窗: At hospital discharge (up to approx. day 10)
Measured via the BCSS
Symptom severity
时间窗: 8 weeks following hospital discharge
Measured via the BCSS
次要结局
- Total number of hospitalised days(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)
- Number of acute exacerbations(6 months following hospital discharge)
- Mortality (predicted)(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))
- Disease-specific quality of life(Within 48 hours of presenting to hospital (day 1))
- Disease-specific quality of life(8 weeks following hospital discharge)
- Lung function (spirometry)(At hospital discharge (up to approx. day 10))
- Mortality (actual, all cause)(At hospital discharge (up to approx. day 10))
- Mortality (predicted)(At hospital discharge (up to approx. day 10))
研究者
Christian Osadnik
Physiotherapist, PhD candidate
La Trobe University