None listed
Conditions
Brief summary
Chronic obstructive pulmonary disease (COPD) is a respiratory disorder defined by airflow limitation that is not fully reversible. Individuals diagnosed with COPD present with chronic and progressive breathlessness, cough, and often sputum production. Positive expiratory pressure (PEP) is a form of airway clearance that works by splinting the airways open on expiration and allowing greater movement of air, it has been found to be an effective form of immediate airway clearance. Commercial PEP devices are expensive; however an alternative form of PEP that is inexpensive and is being used by New Zealand and Australian physiotherapists in the treatment of COPD is bubble-PEP. Despite bubble-PEP being used regularly there is limited evidence that assesses the effectiveness of it for its use in secretion clearance in the COPD population. The aim of the study is to assess the effect of bubble-PEP compared with theraPEP 'Registered Trademark' (a type of commercially available PEP) and standard physiotherapy in patients with an acute exacerbation of COPD (AECOPD). The study aims to determine if 1, bubble-PEP has a greater effect on participant reported symptoms of breathlessness, cough and sputum compared with standard physiotherapy; 2, bubble-PEP is comparable to theraPEP 'Registered Trademark'. The study hypothesis is that bubble-PEP will have a greater effect on participant reported symptoms than standard physiotherapy and that bubble-PEP will be as effective as the commercial product theraPEP 'Registered Trademark'.
Interventions
Treatment arm 1. A variable resistance positive expiratory pressure (PEP) device (TheraPEP 'Registered Trademark'), it has six resistance setting with pressures ranging from 10cmH2O to 20cmH2O.
The participant will be instructed to sit upright with elbows resting on a table holding the theraPEP 'Registered Trademark' device in front of them. The participant will be instructed to seal their lips around the mouth piece and exhale with a little force for three seconds only so the blue disc rises
Treatment arm 1. A variable resistance positive expiratory pressure (PEP) device (TheraPEP 'Registered Trademark'), it has six resistance setting with pressures ranging from 10cmH2O to 20cmH2O. The participant will be instructed to sit upright with elbows resting on a table holding the theraPEP 'Registered Trademark' device in front of them. The participant will be instructed to seal their lips around the mouth piece and exhale with a little force for three seconds only so the blue disc rises and reaches between the lower and upper black line. They will repeat this for 10 breaths, followed by two huffs (Forced expiratory technique (FET) – a demonstration maybe helpful) and a cough. The full set will be repeated two more times to complete each session. There will be a two minute rest between each set. The first treatment session will be supervised and participants will be instructed to complete two further unsupervised sessions, one in the afternoon and another later that night. Participants will complete a diary after each treatment session. Participants will be shown how to and instructed to increase the resistance if they are reaching the top black line too easily as per the usual method of use. Treatment arm 2 - Bubble-PEP is a threshold resistor PEP system constructed using a plastic bottle, 10cm water and flexible plastic tubing. Bubble-PEP to be set up with 10cm of water (line marked on the bottle), a length of suction tubing placed down the handle of a two litre new plastic bottle. The bubble-PEP device will be set up on a table in front of the participant with the participant sitting upright. Participants will be instructed to seal their lips around the tubing and exhale with a little force for three seconds only to create bubbles. Participants will repeat this for 10 breaths, followed by two huffs (FET – a demonstration maybe helpful) and a cough. The full set is to be repeated two more times to complete the treatment session. There will be a two minute rest between each set. Participants will be supervised for their first session and a handout given. Participants will be instructed to complete 2 further unsupervised sessions, one in the afternoon and one later that night. Participants will complete a diary after each treatment session. The water in the bottle will be changed after each treatment session and refilled to the marked line to ensure 10cm of water as per the Counties Manukau District Health Board (CMDHB) bubble–PEP device procedure
Sponsors
Brigitte Eastwood
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosis of mild, moderate or severe COPD (as defined by spirometry) based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 18 years or over. Admitted to Middlemore Hospital medical wards. Exacerbation with reported sputum based on GOLD definition from COPDx Guidelines (An exacerbation is an event in the natural course of the disease characterised by a change in the patient’s baseline dyspnoea, cough, and/or sputum that is beyond normal day-to-day variations, is acute in onset, and may warrant a change in regular medication in a patient with underlying COPD) English speaking and reading Consent to research
Exclusion criteria
Non English speaking or reading Unable to complete questionnaires or actively participate in treatment for any other reason (medical, physical, psychological) Any previous PEP use at home Receiving Bilevel positive airway pressure (BiPAP) treatment (as already receiving a form of positive pressure) Any contraindications to PEP - large bullous disease, undrained pneumothorax Any contraindications to airway clearance techniques, namely frank haemoptysis Any patients previously recruited into this trial on any other admission
Outcome results
None listed