Vibratory PEP Device and Hospital Length of Stay for Acute Exacerbation of COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Device: Acapella Vibratory PEP Therapy Device plus usual careDevice: Sham Acapella Vibratory PEP Device plus usual care
- Registration Number
- NCT03094806
- Lead Sponsor
- New York Presbyterian Brooklyn Methodist Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 91
- Admitted with COPD exacerbation as a primary diagnosis
- Subjectively produces more than 1 tablespoon (15 ml) / day of sputum
- Has the subjective feeling that he/she cannot cough up or clear her secretions
- Physical respiratory system exam by the physician with evidence of course ronchi suggestive of impacted secretions
- > 10 pack-year smoking history
- Cannot use the flutter device or unable to follow commands
- Altered mental status
- Known active malignancy
- Known systolic congestive heart failure (CHF) with ejection fraction (EF) < 40% or clinically in acute CHF exacerbation as documented by cardiologist or primary diagnosis other than COPD
- Pregnancy
- Patients in severe exacerbation (Intubated, Continuous use of NIPPV, Unable to speak full sentences)
- Intracranial pressure (ICP) >20 mmHg
- Hemodynamic instability (requiring vasopressor support)
- Recent facial, oral, or skull surgery or trauma.
- Acute sinusitis.
- Epistaxis.
- Esophageal surgery.
- Active Hemoptysis (More than 2 tablespoons of frank blood per day)
- Nausea.
- Severe earache or discharge from ear. (Known or suspected tympanic membrane rupture or other middle ear pathology)
- Untreated pneumothorax.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acapella Vibratory PEP Therapy Device Acapella Vibratory PEP Therapy Device plus usual care Subject will use the device 3 times a day throughout hospital stay Sham Acapella Vibratory PEP Device Sham Acapella Vibratory PEP Device plus usual care Subject will use the sham device 3 times a day throughout hospital stay
- Primary Outcome Measures
Name Time Method Length of Stay Up to 2 weeks Time of admission to time of discharge from hospital
- Secondary Outcome Measures
Name Time Method Difference in Bedside Spirometry Day 5 Degree of airflow obstruction (FEV1/FVC)
Analysis of Change in Daily Sputum Production Up to 5 days Sputum production in a 24 hour period in mL volume
Dyspnea on the Borg Scale Up to 5 days 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.
Dyspnea on the MMRC Scale Up to 5 days 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.
In Hospital Mortality Up to 2 weeks Death at the time of discharge
Change in 6MWT Test Day 1 and Day 5 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.
Trial Locations
- Locations (1)
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States