Status:
RECRUITING
Oscillating Positive Expiratory Pressure Devices and Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Ain Shams University
Collaborating Sponsors:
Trudell Medical International
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
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 positiv...
Detailed Description
In this study, investigators will investigate the change of objective measurements of lung functions and exercise capacity in addition to subjective measures of quality of life.
Eligibility Criteria
Inclusion
- COPD patients, stages 3-4 according to GOLD guidelines 2016, with post bronchodilator FEV1/FVC \< 70% of predicted and FEV1 \< 50% with exacerbations necessitates hospital admission.
- Smokers or Ex-smokers.
- Able and willing to provide informed signed consent. Able and understanding the correct use of the bronchial clearing device.
- Able to perform effectively spirometry.
- Able and willing to receive the management plane as indicated including systemic steroids if seemed necessary.
Exclusion
- Other obstructive pulmonary diseases or those do not fulfill the criteria of COPD diagnosis.
- Nonsmokers.
- Presence of major comorbidity causing organ dysfunction as cardiac (including severe pulmonary hypertension), renal, or liver impairment (not including diabetes, arterial hypertension, or obesity).
- Presence of lobar pneumonia.
- Suspicion of bronchogenic malignancy.
- Any other complication either at admission or during hospital stay as pneumothorax, pulmonary embolism, myocardial infarction, acute coronary syndrome, cerebrovascular accidents, ...
- Patients unable or not willing to provide informed signed consent.
- Patients unable to use the bronchial clearing device.
- Patients unable to perform spirometry.
- Patients unable or not willing to comply to the management plan or the study protocol.
- Patients receiving regular oral steroids or non-selective beta blockers.
Key Trial Info
Start Date :
January 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03299231
Start Date
January 22 2018
End Date
October 1 2024
Last Update
May 23 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ain Shams University Hospital
Cairo, Egypt