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

Purpose

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	Intervention
Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive	Device: Positive expiratory pressure (PEP) mask therapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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)?

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Further study details as provided by La Trobe University:

Primary Outcome Measures:

Symptom severity [ Time Frame: Within 48 hours of presenting to hospital (day 1) ] [ Designated as safety issue: No ]
Measured via the Breathlessness, Cough and Sputum Scale (BCSS).
Symptom severity [ Time Frame: At hospital discharge (up to approx. day 10) ] [ Designated as safety issue: No ]
Measured via the BCSS
Symptom severity [ Time Frame: 8 weeks following hospital discharge ] [ Designated as safety issue: No ]
Measured via the BCSS
Symptom severity [ Time Frame: 6 months following hospital discharge ] [ Designated as safety issue: No ]
Measured via the BCSS

Secondary Outcome Measures:

Disease-specific quality of life [ Time Frame: Within 48 hours of presenting to hospital (day 1) ] [ Designated as safety issue: No ]
Measured via the 4-week English (Australian) version of the St. George's Respiratory Questionnaire (SGRQ).
Disease-specific quality of life [ Time Frame: 8 weeks following hospital discharge ] [ Designated as safety issue: No ]
Measured via the SGRQ
Disease-specific quality of life [ Time Frame: 6 months following hospital discharge ] [ Designated as safety issue: No ]
Measured via the SGRQ
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) ] [ Designated as safety issue: Yes ]
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 [ Time Frame: At hospital discharge (up to approx. day 10) ] [ Designated as safety issue: No ]
Measured as number of days
Time to first exacerbation [ Time Frame: 6 months following hospital discharge ] [ Designated as safety issue: No ]
Measured as number of days
Time to first hospitalisation (due to respiratory illness) [ Time Frame: 6 months following hospital discharge ] [ Designated as safety issue: No ]
Measured as number of days
Number of acute exacerbations [ Time Frame: 6 months following hospital discharge ] [ Designated as safety issue: No ]
Measured as number of events
Number of hospitalisations (due to respiratory illness) [ Time Frame: 6 months following hospital discharge ] [ Designated as safety issue: No ]
Measured as number of events
Total number of hospitalised days [ Time Frame: 6 months following hospital discharge ] [ Designated as safety issue: No ]
Measured as number of hospitalised days
Lung function (spirometry) [ Time Frame: At hospital discharge (up to approx. day 10) ] [ Designated as safety issue: No ]
e.g. FEV1, FVC, FEV1/FVC%
Lung function (spirometry) [ Time Frame: 6 months following hospital discharge ] [ Designated as safety issue: No ]
e.g. FEV1, FVC, FEV1/FVC%
Mortality (actual, all cause) [ Time Frame: At hospital discharge (up to approx. day 10) ] [ Designated as safety issue: Yes ]
Measured as number of events
Mortality (actual, all cause) [ Time Frame: 6 months following hospital discharge ] [ Designated as safety issue: Yes ]
Measured as number of events
Mortality (predicted) [ Time Frame: At hospital discharge (up to approx. day 10) ] [ Designated as safety issue: Yes ]
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) [ Time Frame: 6 months following hospital discharge ] [ Designated as safety issue: Yes ]
Measured via BODE index

Enrollment:	92
Study Start Date:	July 2010
Study Completion Date:	January 2013
Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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).

Arms

Assigned Interventions

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).

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.

Eligibility

Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01101282

Locations

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

Sponsors and Collaborators

La Trobe University

The Alfred

Austin Hospital, Melbourne Australia

Investigators

Principal Investigator:

Christian R Osadnik, Bachelor of Physiotherapy

La Trobe University

More Information

No publications provided

Responsible Party:	Christian Osadnik, Physiotherapist, PhD candidate, La Trobe University
ClinicalTrials.gov Identifier:	NCT01101282 History of Changes
Other Study ID Numbers:	(not yet specified)
Study First Received:	April 7, 2010
Last Updated:	February 13, 2013
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by La Trobe University:

PEP
exacerbation
physiotherapy

airway clearance
sputum
physical Therapy modalities

Additional relevant MeSH terms:

Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 13, 2013