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

NCT01101282 | Completed

• 1 other identifier: (not yet specified)
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 2

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.

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive

Keywords

PEP; exacerbation; physiotherapy; airway clearance; sputum; physical Therapy modalities

Outcome Measures

Primary Outcomes (4)

• Symptom severity

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

  Within 48 hours of presenting to hospital (day 1)

• Symptom severity

  Measured via the BCSS

  At hospital discharge (up to approx. day 10)

• Symptom severity

  Measured via the BCSS

  8 weeks following hospital discharge

• Symptom severity

  Measured via the BCSS

  6 months following hospital discharge

Secondary Outcomes (16)

• Disease-specific quality of life

  Within 48 hours of presenting to hospital (day 1)

• Disease-specific quality of life

  8 weeks following hospital discharge

• Disease-specific quality of life

  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)

  At hospital discharge (up to approx. day 10)

• Hospital length of stay

  At hospital discharge (up to approx. day 10)

Study Arms (2)

'Usual care'

NO INTERVENTION

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.

'Usual care' plus PEP mask therapy

EXPERIMENTAL

This will comprise: * 'Usual care' * PEP mask therapy

Device: Positive expiratory pressure (PEP) mask therapy

Interventions

Positive expiratory pressure (PEP) mask therapy 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).

'Usual care' plus PEP mask therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• La Trobe University: lead
• The Alfred: collaborator
• Austin Hospital, Melbourne Australia: collaborator

Study Sites (2)

The Austin Hospital

Melbourne, Victoria, 3084, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3181, Australia

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christian R Osadnik, Bachelor of Physiotherapy

  La Trobe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, PhD candidate

Study Record Dates

• First Submitted: April 7, 2010
• First Posted: April 9, 2010
• Study Start: July 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

AU (2)