This study is evaluating the use of a respiratory device, the Acapella Vibratory Positive Expiratory Pressure (PEP) Therapy device, in patients admitted to the hospital with a chronic obstructive pulmonary disease (COPD) exacerbation.
The investigators hypothesize that the PEP-FV used as adjunctive therapy in patients hospitalized for an acute exacerbation of COPD will result in decreased hospital length of stay and improvement of overall COPD-related health outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
91
The acapella® Vibratory PEP Therapy System (PEP-FV) device is a handheld device that operates in same principle as standard FV. Unlike standard FV, it is not gravity dependent. It comes in two different devices to accommodate for different flows rates of the patient. It has similar properties of a standard FV and may be better tolerated.
The Sham Acapella Vibratory PEP Device is the same as the Therapy Device, except the flutter valve has been removed from the device.
New York Methodist Hospital
Brooklyn, New York, United States
Length of Stay
Time of admission to time of discharge from hospital
Time frame: Up to 2 weeks
Analysis of Change in Daily Sputum Production
Sputum production in a 24 hour period in mL volume
Time frame: Up to 5 days
Dyspnea on the Borg Scale
Scale is used to rate the difficulty of breathing. It starts at 0 where the breathing is causing no difficulty at all and progresses through to number 10 where the breathing difficulty is maximal.
Time frame: Up to 5 days
Dyspnea on the MMRC Scale
The Modified Medical Research Council (MMRC) dyspnea scale is used to assess an individual's shortness of breath. It starts at 0 where the shortness of breath occurs during strenuous exercise and progresses through to number 4 where the shortness of breath is maximal.
Time frame: Up to 5 days
Change in 6MWT Test
A six-minute walk test (6MWT) measures the distance that an individual can walk on a flat, hard surface in a period of six minutes. This is used to assess the exercise tolerance measured by the difference in meters between the tests.
Time frame: Day 1 and Day 5
Difference in Bedside Spirometry
Degree of airflow obstruction (FEV1/FVC)
Time frame: Day 5
In Hospital Mortality
Death at the time of discharge
Time frame: Up to 2 weeks
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