Chronic Obstructive Pulmonary Disease
Conditions
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.
Interventions
DEVICEAcapella 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.
DEVICESham 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.
Sponsors
New York Presbyterian Brooklyn Methodist Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | Up to 2 weeks | Time of admission to time of discharge from hospital |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Analysis of Change in Daily Sputum Production | Up to 5 days | Sputum production in a 24 hour period in mL volume |
| Difference in Bedside Spirometry | Day 5 | Degree of airflow obstruction (FEV1/FVC) |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 44 |
| 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. | 47 |
| Total | 91 |
Baseline characteristics
| Characteristic | Total | Acapella Vibratory PEP Therapy Device | Sham Acapella Vibratory PEP Device |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 43 Participants | 16 Participants | 27 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants | 28 Participants | 20 Participants |
| Age, Continuous | 64.0 years STANDARD_DEVIATION 11.6 | 61.8 years STANDARD_DEVIATION 10.6 | 65.9 years STANDARD_DEVIATION 12.2 |
| Body Mass Index (BMI) | 32.6 kg/m^2 STANDARD_DEVIATION 10.3 | 34.6 kg/m^2 STANDARD_DEVIATION 11.9 | 30.7 kg/m^2 STANDARD_DEVIATION 8.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 31 Participants | 13 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) White | 60 Participants | 31 Participants | 29 Participants |
| Region of Enrollment United States | 91 participants | 44 participants | 47 participants |
| Sex: Female, Male Female | 58 Participants | 29 Participants | 29 Participants |
| Sex: Female, Male Male | 33 Participants | 15 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 44 | 0 / 47 |
| serious Total, serious adverse events | 0 / 44 | 0 / 47 |
Outcome results
Primary
Length of Stay
Time of admission to time of discharge from hospital
Time frame: Up to 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Acapella Vibratory PEP Therapy Device | Length of Stay | 4.8 days |
| Sham Acapella Vibratory PEP Device | Length of Stay | 3.2 days |
Secondary
Analysis of Change in Daily Sputum Production
Sputum production in a 24 hour period in mL volume
Time frame: Up to 5 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acapella Vibratory PEP Therapy Device | Analysis of Change in Daily Sputum Production | Sputum production day 2 | 7.5 volume in mL | Standard Deviation 8.5 |
| Acapella Vibratory PEP Therapy Device | Analysis of Change in Daily Sputum Production | Sputum production day 4 | 5.3 volume in mL | Standard Deviation 7 |
| Acapella Vibratory PEP Therapy Device | Analysis of Change in Daily Sputum Production | Sputum production day 3 | 6.5 volume in mL | Standard Deviation 6.7 |
| Acapella Vibratory PEP Therapy Device | Analysis of Change in Daily Sputum Production | Sputum production day 5 | 2.9 volume in mL | Standard Deviation 5.7 |
| Acapella Vibratory PEP Therapy Device | Analysis of Change in Daily Sputum Production | Sputum production day 1 | 6.6 volume in mL | Standard Deviation 8.8 |
| Sham Acapella Vibratory PEP Device | Analysis of Change in Daily Sputum Production | Sputum production day 5 | 13.3 volume in mL | Standard Deviation 15.9 |
| Sham Acapella Vibratory PEP Device | Analysis of Change in Daily Sputum Production | Sputum production day 1 | 14.6 volume in mL | Standard Deviation 17.6 |
| Sham Acapella Vibratory PEP Device | Analysis of Change in Daily Sputum Production | Sputum production day 2 | 15.9 volume in mL | Standard Deviation 16.8 |
| Sham Acapella Vibratory PEP Device | Analysis of Change in Daily Sputum Production | Sputum production day 3 | 15.9 volume in mL | Standard Deviation 16.6 |
| Sham Acapella Vibratory PEP Device | Analysis of Change in Daily Sputum Production | Sputum production day 4 | 13.4 volume in mL | Standard Deviation 16.4 |
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.
Time frame: Day 1 and Day 5
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acapella Vibratory PEP Therapy Device | Change in 6MWT Test | 6MWT day 1 | 168.8 meters | Standard Deviation 118.9 |
| Acapella Vibratory PEP Therapy Device | Change in 6MWT Test | 6 MWT day 5 | 200.1 meters | Standard Deviation 90.3 |
| Sham Acapella Vibratory PEP Device | Change in 6MWT Test | 6MWT day 1 | 206.7 meters | Standard Deviation 120.8 |
| Sham Acapella Vibratory PEP Device | Change in 6MWT Test | 6 MWT day 5 | 199.3 meters | Standard Deviation 119.9 |
Secondary
Difference in Bedside Spirometry
Degree of airflow obstruction (FEV1/FVC)
Time frame: Day 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acapella Vibratory PEP Therapy Device | Difference in Bedside Spirometry | 70.7 ratio | Standard Deviation 20.6 |
| Sham Acapella Vibratory PEP Device | Difference in Bedside Spirometry | 57.7 ratio | Standard Deviation 13.8 |
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.
Time frame: Up to 5 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acapella Vibratory PEP Therapy Device | Dyspnea on the Borg Scale | Borg scale day 2 | 3.7 score on a scale | Standard Deviation 2.1 |
| Acapella Vibratory PEP Therapy Device | Dyspnea on the Borg Scale | Borg scale day 4 | 2.9 score on a scale | Standard Deviation 2.1 |
| Acapella Vibratory PEP Therapy Device | Dyspnea on the Borg Scale | Borg scale day 3 | 3.3 score on a scale | Standard Deviation 2.2 |
| Acapella Vibratory PEP Therapy Device | Dyspnea on the Borg Scale | Borg scale day 5 | 3.1 score on a scale | Standard Deviation 2.4 |
| Acapella Vibratory PEP Therapy Device | Dyspnea on the Borg Scale | Borg scale day 1 | 5.0 score on a scale | Standard Deviation 2.4 |
| Sham Acapella Vibratory PEP Device | Dyspnea on the Borg Scale | Borg scale day 5 | 3.2 score on a scale | Standard Deviation 2 |
| Sham Acapella Vibratory PEP Device | Dyspnea on the Borg Scale | Borg scale day 1 | 5.1 score on a scale | Standard Deviation 2.5 |
| Sham Acapella Vibratory PEP Device | Dyspnea on the Borg Scale | Borg scale day 2 | 4.3 score on a scale | Standard Deviation 2.5 |
| Sham Acapella Vibratory PEP Device | Dyspnea on the Borg Scale | Borg scale day 3 | 3.3 score on a scale | Standard Deviation 2.2 |
| Sham Acapella Vibratory PEP Device | Dyspnea on the Borg Scale | Borg scale day 4 | 3.3 score on a scale | Standard Deviation 2.5 |
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.
Time frame: Up to 5 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acapella Vibratory PEP Therapy Device | Dyspnea on the MMRC Scale | MMRC scale day 2 | 1.9 score on a scale | Standard Deviation 1 |
| Acapella Vibratory PEP Therapy Device | Dyspnea on the MMRC Scale | MMRC scale day 4 | 1.7 score on a scale | Standard Deviation 1 |
| Acapella Vibratory PEP Therapy Device | Dyspnea on the MMRC Scale | MMRC scale day 3 | 1.7 score on a scale | Standard Deviation 1 |
| Acapella Vibratory PEP Therapy Device | Dyspnea on the MMRC Scale | MMRC scale day 5 | 1.8 score on a scale | Standard Deviation 1 |
| Acapella Vibratory PEP Therapy Device | Dyspnea on the MMRC Scale | MMRC scale day 1 | 2.2 score on a scale | Standard Deviation 1 |
| Sham Acapella Vibratory PEP Device | Dyspnea on the MMRC Scale | MMRC scale day 5 | 2.4 score on a scale | Standard Deviation 0.9 |
| Sham Acapella Vibratory PEP Device | Dyspnea on the MMRC Scale | MMRC scale day 1 | 2.4 score on a scale | Standard Deviation 1.3 |
| Sham Acapella Vibratory PEP Device | Dyspnea on the MMRC Scale | MMRC scale day 2 | 2.1 score on a scale | Standard Deviation 1.4 |
| Sham Acapella Vibratory PEP Device | Dyspnea on the MMRC Scale | MMRC scale day 3 | 2.2 score on a scale | Standard Deviation 1.4 |
| Sham Acapella Vibratory PEP Device | Dyspnea on the MMRC Scale | MMRC scale day 4 | 2.2 score on a scale | Standard Deviation 1.3 |
Secondary
In Hospital Mortality
Death at the time of discharge
Time frame: Up to 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acapella Vibratory PEP Therapy Device | In Hospital Mortality | 0 Participants |
| Sham Acapella Vibratory PEP Device | In Hospital Mortality | 0 Participants |