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

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ClinicalTrials.gov Identifier: NCT01101282
Recruitment Status : Completed
First Posted : April 9, 2010
Last Update Posted : February 15, 2013
Sponsor:
Collaborators:
The Alfred
Austin Hospital, Melbourne Australia
Information provided by (Responsible Party):
Christian Osadnik, La Trobe University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Device: Positive expiratory pressure (PEP) mask therapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)?
Study Start Date : July 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arms and Interventions
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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
 Device: 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).


Outcome Measures
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Primary Outcome Measures :
  1. Symptom severity [ Time Frame: Within 48 hours of presenting to hospital (day 1) ]
    Measured via the Breathlessness, Cough and Sputum Scale (BCSS).

  2. Symptom severity [ Time Frame: At hospital discharge (up to approx. day 10) ]
    Measured via the BCSS

  3. Symptom severity [ Time Frame: 8 weeks following hospital discharge ]
    Measured via the BCSS

  4. Symptom severity [ Time Frame: 6 months following hospital discharge ]
    Measured via the BCSS


Secondary Outcome Measures :
  1. 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).

  2. Disease-specific quality of life [ Time Frame: 8 weeks following hospital discharge ]
    Measured via the SGRQ

  3. Disease-specific quality of life [ Time Frame: 6 months following hospital discharge ]
    Measured via the SGRQ

  4. 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.

  5. Hospital length of stay [ Time Frame: At hospital discharge (up to approx. day 10) ]
    Measured as number of days

  6. Time to first exacerbation [ Time Frame: 6 months following hospital discharge ]
    Measured as number of days

  7. Time to first hospitalisation (due to respiratory illness) [ Time Frame: 6 months following hospital discharge ]
    Measured as number of days

  8. Number of acute exacerbations [ Time Frame: 6 months following hospital discharge ]
    Measured as number of events

  9. Number of hospitalisations (due to respiratory illness) [ Time Frame: 6 months following hospital discharge ]
    Measured as number of events

  10. Total number of hospitalised days [ Time Frame: 6 months following hospital discharge ]
    Measured as number of hospitalised days

  11. Lung function (spirometry) [ Time Frame: At hospital discharge (up to approx. day 10) ]
    e.g. FEV1, FVC, FEV1/FVC%

  12. Lung function (spirometry) [ Time Frame: 6 months following hospital discharge ]
    e.g. FEV1, FVC, FEV1/FVC%

  13. Mortality (actual, all cause) [ Time Frame: At hospital discharge (up to approx. day 10) ]
    Measured as number of events

  14. Mortality (actual, all cause) [ Time Frame: 6 months following hospital discharge ]
    Measured as number of events

  15. 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).

  16. Mortality (predicted) [ Time Frame: 6 months following hospital discharge ]
    Measured via BODE index


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101282


Locations
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Australia, Victoria
The Austin Hospital
Melbourne, Victoria, Australia, 3084
The Alfred Hospital
Melbourne, Victoria, Australia, 3181
Sponsors and Collaborators
La Trobe University
The Alfred
Austin Hospital, Melbourne Australia
Investigators
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Principal Investigator: Christian R Osadnik, Bachelor of Physiotherapy La Trobe University
More Information
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Responsible Party: Christian Osadnik, Physiotherapist, PhD candidate, La Trobe University
ClinicalTrials.gov Identifier: NCT01101282    
Other Study ID Numbers: (not yet specified)
First Posted: April 9, 2010    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013
Keywords provided by Christian Osadnik, La Trobe University:
PEP
exacerbation
physiotherapy
 airway clearance
sputum
physical Therapy modalities
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases