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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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)?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01101282
• Other study ID #: (not yet specified)
• Status: Completed
• Phase: N/A
• First received: April 7, 2010
• Last updated: February 13, 2013
• Start date: July 2010
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: La Trobe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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).

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	The Austin Hospital	Melbourne	Victoria

Sponsors (3)

Lead Sponsor	Collaborator
La Trobe University	Austin Hospital, Melbourne Australia, The Alfred

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom severity	Measured via the Breathlessness, Cough and Sputum Scale (BCSS).	Within 48 hours of presenting to hospital (day 1)	No
Primary	Symptom severity	Measured via the BCSS	At hospital discharge (up to approx. day 10)	No
Primary	Symptom severity	Measured via the BCSS	8 weeks following hospital discharge	No
Primary	Symptom severity	Measured via the BCSS	6 months following hospital discharge	No
Secondary	Disease-specific quality of life	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)	No
Secondary	Disease-specific quality of life	Measured via the SGRQ	8 weeks following hospital discharge	No
Secondary	Disease-specific quality of life	Measured via the SGRQ	6 months following hospital discharge	No
Secondary	Need for assisted (non-invasive and/or invasive) ventilation during hospitalisation (within, and after 48 hours of presentation to hospital)	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)	Yes
Secondary	Hospital length of stay	Measured as number of days	At hospital discharge (up to approx. day 10)	No
Secondary	Time to first exacerbation	Measured as number of days	6 months following hospital discharge	No
Secondary	Time to first hospitalisation (due to respiratory illness)	Measured as number of days	6 months following hospital discharge	No
Secondary	Number of acute exacerbations	Measured as number of events	6 months following hospital discharge	No
Secondary	Number of hospitalisations (due to respiratory illness)	Measured as number of events	6 months following hospital discharge	No
Secondary	Total number of hospitalised days	Measured as number of hospitalised days	6 months following hospital discharge	No
Secondary	Lung function (spirometry)	e.g. FEV1, FVC, FEV1/FVC%	At hospital discharge (up to approx. day 10)	No
Secondary	Lung function (spirometry)	e.g. FEV1, FVC, FEV1/FVC%	6 months following hospital discharge	No
Secondary	Mortality (actual, all cause)	Measured as number of events	At hospital discharge (up to approx. day 10)	Yes
Secondary	Mortality (actual, all cause)	Measured as number of events	6 months following hospital discharge	Yes
Secondary	Mortality (predicted)	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)	Yes
Secondary	Mortality (predicted)	Measured via BODE index	6 months following hospital discharge	Yes