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

February 13, 2013 updated by: Christian Osadnik, La Trobe University

Does the Addition of Positive Expiratory Pressure (PEP) Mask Therapy to Usual Medical Care Improve Patients' Symptoms, Quality or Life and Risk of Future Exacerbations in Individuals With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)?

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Victoria
      • Melbourne, Victoria, Australia, 3181
        • The Alfred Hospital
      • Melbourne, Victoria, Australia, 3084
        • The Austin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: '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.
Experimental: 'Usual care' plus PEP mask therapy

This will comprise:

  • 'Usual care'
  • 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom severity
Time Frame: Within 48 hours of presenting to hospital (day 1)
Measured via the Breathlessness, Cough and Sputum Scale (BCSS).
Within 48 hours of presenting to hospital (day 1)
Symptom severity
Time Frame: At hospital discharge (up to approx. day 10)
Measured via the BCSS
At hospital discharge (up to approx. day 10)
Symptom severity
Time Frame: 8 weeks following hospital discharge
Measured via the BCSS
8 weeks following hospital discharge
Symptom severity
Time Frame: 6 months following hospital discharge
Measured via the BCSS
6 months following hospital discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-specific quality of life
Time Frame: Within 48 hours of presenting to hospital (day 1)
Measured via the 4-week English (Australian) version of the St. George's Respiratory Questionnaire (SGRQ).
Within 48 hours of presenting to hospital (day 1)
Disease-specific quality of life
Time Frame: 8 weeks following hospital discharge
Measured via the SGRQ
8 weeks following hospital discharge
Disease-specific quality of life
Time Frame: 6 months following hospital discharge
Measured via the SGRQ
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)
Time Frame: 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.
At hospital discharge (up to approx. day 10)
Hospital length of stay
Time Frame: At hospital discharge (up to approx. day 10)
Measured as number of days
At hospital discharge (up to approx. day 10)
Time to first exacerbation
Time Frame: 6 months following hospital discharge
Measured as number of days
6 months following hospital discharge
Time to first hospitalisation (due to respiratory illness)
Time Frame: 6 months following hospital discharge
Measured as number of days
6 months following hospital discharge
Number of acute exacerbations
Time Frame: 6 months following hospital discharge
Measured as number of events
6 months following hospital discharge
Number of hospitalisations (due to respiratory illness)
Time Frame: 6 months following hospital discharge
Measured as number of events
6 months following hospital discharge
Total number of hospitalised days
Time Frame: 6 months following hospital discharge
Measured as number of hospitalised days
6 months following hospital discharge
Lung function (spirometry)
Time Frame: At hospital discharge (up to approx. day 10)
e.g. FEV1, FVC, FEV1/FVC%
At hospital discharge (up to approx. day 10)
Lung function (spirometry)
Time Frame: 6 months following hospital discharge
e.g. FEV1, FVC, FEV1/FVC%
6 months following hospital discharge
Mortality (actual, all cause)
Time Frame: At hospital discharge (up to approx. day 10)
Measured as number of events
At hospital discharge (up to approx. day 10)
Mortality (actual, all cause)
Time Frame: 6 months following hospital discharge
Measured as number of events
6 months following hospital discharge
Mortality (predicted)
Time Frame: At hospital discharge (up to approx. day 10)
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).
At hospital discharge (up to approx. day 10)
Mortality (predicted)
Time Frame: 6 months following hospital discharge
Measured via BODE index
6 months following hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christian R Osadnik, Bachelor of Physiotherapy, La Trobe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

April 7, 2010

First Submitted That Met QC Criteria

April 8, 2010

First Posted (Estimate)

April 9, 2010

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 13, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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