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

NCT ID: NCT01101282

Last Updated: 2013-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-01-31

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.

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

'Usual care'

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

'Usual care' plus PEP mask therapy

This will comprise:

• 'Usual care'
• PEP mask therapy

Group Type: EXPERIMENTAL

Positive expiratory pressure (PEP) mask therapy

Intervention Type: DEVICE

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).

Interventions

Positive 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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Alfred

OTHER

Sponsor Role: collaborator

Austin Hospital, Melbourne Australia

OTHER

Sponsor Role: collaborator

La Trobe University

OTHER

Sponsor Role: lead

Responsible Party

Christian Osadnik

Physiotherapist, PhD candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christian R Osadnik, Bachelor of Physiotherapy

Role: PRINCIPAL_INVESTIGATOR

La Trobe University

Locations

The Austin Hospital

Melbourne, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

(not yet specified)

Identifier Type: -

Identifier Source: org_study_id