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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acapella Vibratory PEP Therapy Device | Experimental | Subject will use the device 3 times a day throughout hospital stay |
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| Sham Acapella Vibratory PEP Device | Placebo Comparator | Subject will use the sham device 3 times a day throughout hospital stay |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acapella Vibratory PEP Therapy Device plus usual care | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | Time of admission to time of discharge from hospital | Up to 2 weeks |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy A Weingarten, MD | New York Presbyterian Brooklyn Methodist Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Methodist Hospital | Brooklyn | New York | 11215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31819393 | Derived | Milan S, Bondalapati P, Megally M, Patel E, Vaghasia P, Gross L, Bachman EM, Chadha P, Weingarten JA. Positive Expiratory Pressure Therapy With And Without Oscillation And Hospital Length Of Stay For Acute Exacerbation Of Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2019 Nov 20;14:2553-2561. doi: 10.2147/COPD.S213546. eCollection 2019. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acapella Vibratory PEP Therapy Device | Subject will use the device 3 times a day throughout hospital stay Acapella Vibratory PEP Therapy Device plus usual care: 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Sham Acapella Vibratory PEP Device plus usual care | Device | The Sham Acapella Vibratory PEP Device is the same as the Therapy Device, except the flutter valve has been removed from the device. |
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| 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 |
| FG001 | Sham Acapella Vibratory PEP Device | Subject will use the sham device 3 times a day throughout hospital stay Sham Acapella Vibratory PEP Device plus usual care: The Sham Acapella Vibratory PEP Device is the same as the Therapy Device, except the flutter valve has been removed from the device. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Acapella Vibratory PEP Therapy Device | Subject will use the device 3 times a day throughout hospital stay Acapella Vibratory PEP Therapy Device plus usual care: 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. |
| BG001 | Sham Acapella Vibratory PEP Device | Subject will use the sham device 3 times a day throughout hospital stay Sham Acapella Vibratory PEP Device plus usual care: The Sham Acapella Vibratory PEP Device is the same as the Therapy Device, except the flutter valve has been removed from the device. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Length of Stay | Time of admission to time of discharge from hospital | Posted | Median | 95% Confidence Interval | days | Up to 2 weeks |
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| Secondary | Analysis of Change in Daily Sputum Production | Sputum production in a 24 hour period in mL volume | Posted | Mean | Standard Deviation | volume in mL | Up to 5 days |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 5 days |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 5 days |
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| Secondary | 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. | Posted | Mean | Standard Deviation | meters | Day 1 and Day 5 |
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| Secondary | Difference in Bedside Spirometry | Degree of airflow obstruction (FEV1/FVC) | Posted | Mean | Standard Deviation | ratio | Day 5 |
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| Secondary | In Hospital Mortality | Death at the time of discharge | Posted | Count of Participants | Participants | Up to 2 weeks |
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Admission to discharge or Day 5, whichever occurred first.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acapella Vibratory PEP Therapy Device | Subject will use the device 3 times a day throughout hospital stay Acapella Vibratory PEP Therapy Device plus usual care: 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. | 0 | 44 | 0 | 44 | ||
| EG001 | Sham Acapella Vibratory PEP Device | Subject will use the sham device 3 times a day throughout hospital stay Sham Acapella Vibratory PEP Device plus usual care: The Sham Acapella Vibratory PEP Device is the same as the Therapy Device, except the flutter valve has been removed from the device. | 0 | 47 | 0 | 47 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeremy A Weingarten, MD | New York Methodist Hospital | 718-780-5835 | jaw9031@nyp.org |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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