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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
92
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).
The Austin Hospital
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Symptom severity
Measured via the Breathlessness, Cough and Sputum Scale (BCSS).
Time frame: Within 48 hours of presenting to hospital (day 1)
Symptom severity
Measured via the BCSS
Time frame: At hospital discharge (up to approx. day 10)
Symptom severity
Measured via the BCSS
Time frame: 8 weeks following hospital discharge
Symptom severity
Measured via the BCSS
Time frame: 6 months following hospital discharge
Disease-specific quality of life
Measured via the 4-week English (Australian) version of the St. George's Respiratory Questionnaire (SGRQ).
Time frame: Within 48 hours of presenting to hospital (day 1)
Disease-specific quality of life
Measured via the SGRQ
Time frame: 8 weeks following hospital discharge
Disease-specific quality of life
Measured via the SGRQ
Time frame: 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.
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Time frame: At hospital discharge (up to approx. day 10)
Hospital length of stay
Measured as number of days
Time frame: At hospital discharge (up to approx. day 10)
Time to first exacerbation
Measured as number of days
Time frame: 6 months following hospital discharge
Time to first hospitalisation (due to respiratory illness)
Measured as number of days
Time frame: 6 months following hospital discharge
Number of acute exacerbations
Measured as number of events
Time frame: 6 months following hospital discharge
Number of hospitalisations (due to respiratory illness)
Measured as number of events
Time frame: 6 months following hospital discharge
Total number of hospitalised days
Measured as number of hospitalised days
Time frame: 6 months following hospital discharge
Lung function (spirometry)
e.g. FEV1, FVC, FEV1/FVC%
Time frame: At hospital discharge (up to approx. day 10)
Lung function (spirometry)
e.g. FEV1, FVC, FEV1/FVC%
Time frame: 6 months following hospital discharge
Mortality (actual, all cause)
Measured as number of events
Time frame: At hospital discharge (up to approx. day 10)
Mortality (actual, all cause)
Measured as number of events
Time frame: 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).
Time frame: At hospital discharge (up to approx. day 10)
Mortality (predicted)
Measured via BODE index
Time frame: 6 months following hospital discharge