Trial Outcomes & Findings for Vibratory PEP Device and Hospital Length of Stay for Acute Exacerbation of COPD (NCT NCT03094806)
NCT ID: NCT03094806
Last Updated: 2024-03-21
Results Overview
Time of admission to time of discharge from hospital
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
91 participants
Primary outcome timeframe
Up to 2 weeks
Results posted on
2024-03-21
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
47
|
|
Overall Study
COMPLETED
|
44
|
47
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vibratory PEP Device and Hospital Length of Stay for Acute Exacerbation of COPD
Baseline characteristics by cohort
| Measure |
Total
n=91 Participants
Total of all reporting groups
|
Acapella Vibratory PEP Therapy Device
n=44 Participants
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.
|
Sham Acapella Vibratory PEP Device
n=47 Participants
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.
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=5 Participants
|
28 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
43 Participants
n=5 Participants
|
16 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
61.8 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
65.9 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
31 Participants
n=5 Participants
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=5 Participants
|
31 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
NA Participants
n=5 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
NA Participants
n=5 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
91 participants
n=5 Participants
|
44 participants
n=5 Participants
|
47 participants
n=7 Participants
|
|
Body Mass Index (BMI)
|
32.6 kg/m^2
STANDARD_DEVIATION 10.3 • n=5 Participants
|
34.6 kg/m^2
STANDARD_DEVIATION 11.9 • n=5 Participants
|
30.7 kg/m^2
STANDARD_DEVIATION 8.2 • n=7 Participants
|
PRIMARY outcome
Timeframe: Up to 2 weeksTime of admission to time of discharge from hospital
Outcome measures
| Measure |
Acapella Vibratory PEP Therapy Device
n=44 Participants
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.
|
Sham Acapella Vibratory PEP Device
n=47 Participants
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.
|
|---|---|---|
|
Length of Stay
|
4.8 days
Interval 3.9 to 6.1
|
3.2 days
Interval 3.0 to 4.3
|
SECONDARY outcome
Timeframe: Up to 5 daysSputum production in a 24 hour period in mL volume
Outcome measures
| Measure |
Acapella Vibratory PEP Therapy Device
n=44 Participants
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.
|
Sham Acapella Vibratory PEP Device
n=47 Participants
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.
|
|---|---|---|
|
Analysis of Change in Daily Sputum Production
Sputum production day 1
|
6.6 volume in mL
Standard Deviation 8.8
|
14.6 volume in mL
Standard Deviation 17.6
|
|
Analysis of Change in Daily Sputum Production
Sputum production day 2
|
7.5 volume in mL
Standard Deviation 8.5
|
15.9 volume in mL
Standard Deviation 16.8
|
|
Analysis of Change in Daily Sputum Production
Sputum production day 3
|
6.5 volume in mL
Standard Deviation 6.7
|
15.9 volume in mL
Standard Deviation 16.6
|
|
Analysis of Change in Daily Sputum Production
Sputum production day 4
|
5.3 volume in mL
Standard Deviation 7.0
|
13.4 volume in mL
Standard Deviation 16.4
|
|
Analysis of Change in Daily Sputum Production
Sputum production day 5
|
2.9 volume in mL
Standard Deviation 5.7
|
13.3 volume in mL
Standard Deviation 15.9
|
SECONDARY outcome
Timeframe: Up to 5 daysScale 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.
Outcome measures
| Measure |
Acapella Vibratory PEP Therapy Device
n=44 Participants
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.
|
Sham Acapella Vibratory PEP Device
n=47 Participants
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.
|
|---|---|---|
|
Dyspnea on the Borg Scale
Borg scale day 3
|
3.3 score on a scale
Standard Deviation 2.2
|
3.3 score on a scale
Standard Deviation 2.2
|
|
Dyspnea on the Borg Scale
Borg scale day 4
|
2.9 score on a scale
Standard Deviation 2.1
|
3.3 score on a scale
Standard Deviation 2.5
|
|
Dyspnea on the Borg Scale
Borg scale day 5
|
3.1 score on a scale
Standard Deviation 2.4
|
3.2 score on a scale
Standard Deviation 2.0
|
|
Dyspnea on the Borg Scale
Borg scale day 1
|
5.0 score on a scale
Standard Deviation 2.4
|
5.1 score on a scale
Standard Deviation 2.5
|
|
Dyspnea on the Borg Scale
Borg scale day 2
|
3.7 score on a scale
Standard Deviation 2.1
|
4.3 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Up to 5 daysThe 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.
Outcome measures
| Measure |
Acapella Vibratory PEP Therapy Device
n=44 Participants
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.
|
Sham Acapella Vibratory PEP Device
n=47 Participants
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.
|
|---|---|---|
|
Dyspnea on the MMRC Scale
MMRC scale day 1
|
2.2 score on a scale
Standard Deviation 1.0
|
2.4 score on a scale
Standard Deviation 1.3
|
|
Dyspnea on the MMRC Scale
MMRC scale day 2
|
1.9 score on a scale
Standard Deviation 1.0
|
2.1 score on a scale
Standard Deviation 1.4
|
|
Dyspnea on the MMRC Scale
MMRC scale day 3
|
1.7 score on a scale
Standard Deviation 1.0
|
2.2 score on a scale
Standard Deviation 1.4
|
|
Dyspnea on the MMRC Scale
MMRC scale day 4
|
1.7 score on a scale
Standard Deviation 1.0
|
2.2 score on a scale
Standard Deviation 1.3
|
|
Dyspnea on the MMRC Scale
MMRC scale day 5
|
1.8 score on a scale
Standard Deviation 1.0
|
2.4 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Day 1 and Day 5A 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.
Outcome measures
| Measure |
Acapella Vibratory PEP Therapy Device
n=44 Participants
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.
|
Sham Acapella Vibratory PEP Device
n=47 Participants
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.
|
|---|---|---|
|
Change in 6MWT Test
6MWT day 1
|
168.8 meters
Standard Deviation 118.9
|
206.7 meters
Standard Deviation 120.8
|
|
Change in 6MWT Test
6 MWT day 5
|
200.1 meters
Standard Deviation 90.3
|
199.3 meters
Standard Deviation 119.9
|
SECONDARY outcome
Timeframe: Day 5Degree of airflow obstruction (FEV1/FVC)
Outcome measures
| Measure |
Acapella Vibratory PEP Therapy Device
n=44 Participants
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.
|
Sham Acapella Vibratory PEP Device
n=47 Participants
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.
|
|---|---|---|
|
Difference in Bedside Spirometry
|
70.7 ratio
Standard Deviation 20.6
|
57.7 ratio
Standard Deviation 13.8
|
SECONDARY outcome
Timeframe: Up to 2 weeksDeath at the time of discharge
Outcome measures
| Measure |
Acapella Vibratory PEP Therapy Device
n=44 Participants
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.
|
Sham Acapella Vibratory PEP Device
n=47 Participants
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.
|
|---|---|---|
|
In Hospital Mortality
|
0 Participants
|
0 Participants
|
Adverse Events
Acapella Vibratory PEP Therapy Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Acapella Vibratory PEP Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place