Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
PEP, exacerbation, physiotherapy, airway clearance, sputum, physical Therapy modalities
Brief summary
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
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.
Interventions
DEVICEPositive expiratory pressure (PEP) mask therapy
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).
Sponsors
The Alfred
Austin Hospital, Melbourne Australia
La Trobe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom severity | Within 48 hours of presenting to hospital (day 1) | Measured via the Breathlessness, Cough and Sputum Scale (BCSS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| Hospital length of stay | At hospital discharge (up to approx. day 10) | Measured as number of days |
| Time to first exacerbation | 6 months following hospital discharge | Measured as number of days |
| Time to first hospitalisation (due to respiratory illness) | 6 months following hospital discharge | Measured as number of days |
| Number of acute exacerbations | 6 months following hospital discharge | Measured as number of events |
| Disease-specific quality of life | Within 48 hours of presenting to hospital (day 1) | Measured via the 4-week English (Australian) version of the St. George's Respiratory Questionnaire (SGRQ). |
| Total number of hospitalised days | 6 months following hospital discharge | Measured as number of hospitalised days |
| Lung function (spirometry) | At hospital discharge (up to approx. day 10) | e.g. FEV1, FVC, FEV1/FVC% |
| Mortality (actual, all cause) | At hospital discharge (up to approx. day 10) | Measured as number of events |
| Mortality (predicted) | At hospital discharge (up to approx. day 10) | 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). |
| Number of hospitalisations (due to respiratory illness) | 6 months following hospital discharge | Measured as number of events |
Countries
Australia
Outcome results
None listed