Actively Recruiting
Oscillating Positive Expiratory Pressure Devices and Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Led by Ain Shams University · Updated on 2024-05-23
160
Participants Needed
1
Research Sites
349 weeks
Total Duration
On this page
Sponsors
A
Ain Shams University
Lead Sponsor
T
Trudell Medical International
Collaborating Sponsor
AI-Summary
What this Trial Is About
Sputum production increases in acute exacerbation of COPD, both in amount and consistency. It increases airways obstruction and hence delays improvement and prolongs hospital stay. oscillating positive expiratory pressure (OPEP) devices were extensively studied in cystic fibrosis and bronchiectasis. Only seldom studied in chronic bronchitis. This study aims to measure the effects of mucous clearing device in hospitalized patients with acute exacerbation of COPD.
CONDITIONS
Official Title
Oscillating Positive Expiratory Pressure Devices and Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- COPD patients with stage 3 or 4 disease by GOLD 2016 guidelines, with post-bronchodilator FEV1/FVC less than 70% and FEV1 less than 50%, experiencing exacerbations needing hospital admission
- Current or former smokers
- Able and willing to give informed consent and understand how to use the bronchial clearing device
- Able to perform spirometry effectively
- Willing to follow the prescribed management plan including systemic steroids if needed
You will not qualify if you...
- Other obstructive lung diseases or patients not meeting COPD diagnosis criteria
- Non-smokers
- Major organ dysfunction from cardiac (including severe pulmonary hypertension), kidney, or liver disease (excluding diabetes, high blood pressure, or obesity)
- Presence of lobar pneumonia
- Suspicion of lung cancer
- Complications such as pneumothorax, pulmonary embolism, heart attack, stroke during admission or stay
- Unable or unwilling to provide informed consent
- Unable to use the bronchial clearing device
- Unable to perform spirometry
- Unable or unwilling to follow the management plan or study protocol
- Regular use of oral steroids or non-selective beta blockers
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ain Shams University Hospital
Cairo, Egypt
Actively Recruiting
Research Team
H
Hesham H Raafat, M.D.
CONTACT
G
Gihan Elassal, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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