Does Positive Expiratory Pressure Mask Therapy Improve Recovery From Acute Exacerbations of Chronic Obstructive Pulmonary Disease?
- Conditions
- Pulmonary Disease, Chronic ObstructiveLung Diseases, Obstructive
- Interventions
- Device: Positive expiratory pressure (PEP) mask therapy
- Registration Number
- NCT01101282
- Lead Sponsor
- La Trobe University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 'Usual care' plus PEP mask therapy Positive expiratory pressure (PEP) mask therapy This will comprise: * 'Usual care' * PEP mask therapy
- Primary Outcome Measures
Name Time Method Symptom severity 6 months following hospital discharge Measured via the BCSS
- Secondary Outcome Measures
Name Time Method Total number of hospitalised days 6 months following hospital discharge Measured as number of hospitalised days
Number of hospitalisations (due to respiratory illness) 6 months following hospital discharge Measured as number of events
Mortality (actual, all cause) 6 months following hospital discharge Measured as number of events
Lung function (spirometry) 6 months following hospital discharge e.g. FEV1, FVC, FEV1/FVC%
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
Mortality (predicted) 6 months following hospital discharge Measured via BODE index
Disease-specific quality of life 6 months following hospital discharge Measured via the SGRQ
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
Trial Locations
- Locations (2)
The Austin Hospital
🇦🇺Melbourne, Victoria, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia