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

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive

Status

Completed

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

Positive expiratory pressure (PEP) mask therapy

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring PEP, exacerbation, physiotherapy, airway clearance, sputum, physical Therapy modalities

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The Austin Hospital
The Alfred Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

'Usual care'

'Usual care' plus PEP mask therapy

Arm Description

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.

This will comprise: 'Usual care' PEP mask therapy

Outcomes

Primary Outcome Measures

Symptom severity

Measured via the Breathlessness, Cough and Sputum Scale (BCSS).

Symptom severity

Measured via the BCSS

Symptom severity

Measured via the BCSS

Symptom severity

Measured via the BCSS

Secondary Outcome Measures

Disease-specific quality of life

Measured via the 4-week English (Australian) version of the St. George's Respiratory Questionnaire (SGRQ).

Disease-specific quality of life

Measured via the SGRQ

Disease-specific quality of life

Measured via the SGRQ

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.

Hospital length of stay

Measured as number of days

Time to first exacerbation

Measured as number of days

Time to first hospitalisation (due to respiratory illness)

Measured as number of days

Number of acute exacerbations

Measured as number of events

Number of hospitalisations (due to respiratory illness)

Measured as number of events

Total number of hospitalised days

Measured as number of hospitalised days

Lung function (spirometry)

e.g. FEV1, FVC, FEV1/FVC%

Lung function (spirometry)

e.g. FEV1, FVC, FEV1/FVC%

Mortality (actual, all cause)

Measured as number of events

Mortality (actual, all cause)

Measured as number of events

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).

Mortality (predicted)

Measured via BODE index

Full Information

NCT ID

NCT01101282

First Posted

April 7, 2010

Last Updated

February 13, 2013

Sponsor

La Trobe University

Collaborators