Vibratory PEP Device and Hospital Length of Stay for Acute Exacerbation of COPD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Vibratory/Positive Expiratory Pressure Device and Hospital Length of Stay for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: Acapella Vibratory PEP Therapy Device plus usual care
* Device: Sham Acapella Vibratory PEP Device plus usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acapella Vibratory PEP Therapy Device<br>Subject will use the device 3 times a day throughout hospital stay | Device: Acapella Vibratory PEP Therapy Device plus usual care<br>* 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.<br>|
| Placebo Comparator: Sham Acapella Vibratory PEP Device<br>Subject will use the sham device 3 times a day throughout hospital stay | Device: Sham Acapella Vibratory PEP Device plus usual care<br>* The Sham Acapella Vibratory PEP Device is the same as the Therapy Device, except the flutter valve has been removed from the device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay | Time of admission to time of discharge from hospital | Up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of Change in Daily Sputum Production | Sputum production in a 24 hour period in mL volume | 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. | 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. | 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. | Day 1 and Day 5 | 
| Difference in Bedside Spirometry | Degree of airflow obstruction (FEV1/FVC) | Day 5 | 
| In Hospital Mortality | Death at the time of discharge | Up to 2 weeks |