Does Positive Expiratory Pressure Mask Therapy Improve Recovery From Acute Exacerbations of Chronic Obstructive Pulmonary Disease?

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)?

Conditions
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Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive

Intervention / Treatment
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* Device: Positive expiratory pressure (PEP) mask therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (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) Exclusion Criteria (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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 'Usual care'<br>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. | |
| Experimental: 'Usual care' plus PEP mask therapy<br>This will comprise: 'Usual care' PEP mask therapy | Device: Positive expiratory pressure (PEP) mask therapy<br>* PEP mask therapy will be performed once/day, supervised, by an experienced physiotherapist until hospital discharge or ≥ 24 hours without sputum expectoration (whichever comes first). Written instructions shall also be provided, encouraging two more independent PEP mask sessions per day. Each session will comprise up to 5 cycles of 8-10 slightly active breaths, followed by 2 huffs (FET) and 2 coughs. A target pressure of 10-20 cms H20 during the middle of expiration shall be used (monitored via a pressure manometer).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom severity | Measured via the Breathlessness, Cough and Sputum Scale (BCSS). | Within 48 hours of presenting to hospital (day 1) | 
| Symptom severity | Measured via the BCSS | At hospital discharge (up to approx. day 10) | 
| Symptom severity | Measured via the BCSS | 8 weeks following hospital discharge | 
| Symptom severity | Measured via the BCSS | 6 months following hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-specific quality of life | Measured via the 4-week English (Australian) version of the St. George's Respiratory Questionnaire (SGRQ). | Within 48 hours of presenting to hospital (day 1) | 
| Disease-specific quality of life | Measured via the SGRQ | 8 weeks following hospital discharge | 
| Disease-specific quality of life | Measured via the SGRQ | 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) | The number of participants needing non-invasive or invasive ventilation during their inpatient stay shall be assessed. As early non-invasive ventilation is commonly used for the management of acute exacerbations of COPD, this outcome shall be assessed both within and after 48 hours of presentation to hospital. This aims to differentiate usual care from clinical deterioration. | At hospital discharge (up to approx. day 10) | 
| Hospital length of stay | Measured as number of days | At hospital discharge (up to approx. day 10) | 
| Time to first exacerbation | Measured as number of days | 6 months following hospital discharge | 
| Time to first hospitalisation (due to respiratory illness) | Measured as number of days | 6 months following hospital discharge | 
| Number of acute exacerbations | Measured as number of events | 6 months following hospital discharge | 
| Number of hospitalisations (due to respiratory illness) | Measured as number of events | 6 months following hospital discharge | 
| Total number of hospitalised days | Measured as number of hospitalised days | 6 months following hospital discharge | 
| Lung function (spirometry) | e.g. FEV1, FVC, FEV1/FVC% | At hospital discharge (up to approx. day 10) | 
| Lung function (spirometry) | e.g. FEV1, FVC, FEV1/FVC% | 6 months following hospital discharge | 
| Mortality (actual, all cause) | Measured as number of events | At hospital discharge (up to approx. day 10) | 
| Mortality (actual, all cause) | Measured as number of events | 6 months following hospital discharge | 
| Mortality (predicted) | Measured via calculation of the BODE index. The BODE index is derived from: Body mass index, Obstruction severity (spirometry), Dyspnoea (MRC dyspnoea scale) and Exercise tolerance (6 minute walk test). | At hospital discharge (up to approx. day 10) | 
| Mortality (predicted) | Measured via BODE index | 6 months following hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PEP, exacerbation, physiotherapy, airway clearance, sputum, physical Therapy modalities