Trial Outcomes & Findings for Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements (NCT NCT03534986)
NCT ID: NCT03534986
Last Updated: 2018-10-03
Results Overview
Tidal Volume, the lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
30 minutes
Results posted on
2018-10-03
Participant Flow
Participant milestones
| Measure |
AffloVest The Vest Arm
Devices placed on highest intensity / highest frequency
International Biophysics AffloVest: High-frequency chest wall oscillation vest
Hill-Rom The Vest: High-frequency chest wall oscillation vest
|
AffloVest inCourage Arm
Devices placed on highest intensity / highest frequency
International Biophysics AffloVest: High-frequency chest wall oscillation vest
Respirtech inCourage: High-frequency chest wall oscillation vest
|
AffloVest SmartVest Arm
Devices placed on highest intensity / highest frequency
International Biophysics AffloVest: High-frequency chest wall oscillation vest
Electromed SmartVest: High-frequency chest wall oscillation vest
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
12
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
AffloVest The Vest Arm
n=10 Participants
Devices placed on highest intensity / highest frequency
International Biophysics AffloVest: High-frequency chest wall oscillation vest
Hill-Rom The Vest: High-frequency chest wall oscillation vest
|
AffloVest inCourage Arm
n=10 Participants
Devices placed on highest intensity / highest frequency
International Biophysics AffloVest: High-frequency chest wall oscillation vest
Respirtech inCourage: High-frequency chest wall oscillation vest
|
AffloVest SmartVest Arm
n=12 Participants
Devices placed on highest intensity / highest frequency
International Biophysics AffloVest: High-frequency chest wall oscillation vest
Electromed SmartVest: High-frequency chest wall oscillation vest
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=32 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
12 Participants
n=12 Participants
|
32 Participants
n=32 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=32 Participants
|
|
Age, Continuous
|
28.4 years
STANDARD_DEVIATION 11.9 • n=10 Participants
|
30.6 years
STANDARD_DEVIATION 13.3 • n=10 Participants
|
34.7 years
STANDARD_DEVIATION 10.2 • n=12 Participants
|
31.7 years
STANDARD_DEVIATION 11.7 • n=32 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
7 Participants
n=12 Participants
|
13 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
5 Participants
n=12 Participants
|
19 Participants
n=32 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
12 participants
n=12 Participants
|
32 participants
n=32 Participants
|
PRIMARY outcome
Timeframe: 30 minutesTidal Volume, the lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied
Outcome measures
| Measure |
Baseline
n=10 Participants
Patient Baseline Results
|
AffloVest Arm
n=10 Participants
Devices placed on highest intensity / highest frequency
Hill-Rom The Vest: High-frequency chest wall oscillation vest
|
Compressor Arm
n=10 Participants
Devices placed on highest intensity / highest frequency
Compressor-type device
|
|---|---|---|---|
|
TV
|
0.93 L
Interval 0.3 to 2.32
|
1.00 L
Interval 0.27 to 2.28
|
1.07 L
Interval 0.24 to 2.69
|
PRIMARY outcome
Timeframe: 30 minutesPeak Expiratory Flow, a person's maximum speed of expiration
Outcome measures
| Measure |
Baseline
n=10 Participants
Patient Baseline Results
|
AffloVest Arm
n=10 Participants
Devices placed on highest intensity / highest frequency
Hill-Rom The Vest: High-frequency chest wall oscillation vest
|
Compressor Arm
n=10 Participants
Devices placed on highest intensity / highest frequency
Compressor-type device
|
|---|---|---|---|
|
PEF
|
8.19 L/s
Interval 3.96 to 11.82
|
8.28 L/s
Interval 3.5 to 12.0
|
8.13 L/s
Interval 4.23 to 12.89
|
PRIMARY outcome
Timeframe: 30 minutesForced Vital Capacity, the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible
Outcome measures
| Measure |
Baseline
n=10 Participants
Patient Baseline Results
|
AffloVest Arm
n=10 Participants
Devices placed on highest intensity / highest frequency
Hill-Rom The Vest: High-frequency chest wall oscillation vest
|
Compressor Arm
n=10 Participants
Devices placed on highest intensity / highest frequency
Compressor-type device
|
|---|---|---|---|
|
FVC
|
4.29 L
Interval 2.48 to 6.57
|
4.25 L
Interval 2.5 to 7.42
|
4.12 L
Interval 2.29 to 6.73
|
PRIMARY outcome
Timeframe: 30 minutesForced Expiratory Volume, the volume of air that can be forced out in one second after taking a deep breath
Outcome measures
| Measure |
Baseline
n=10 Participants
Patient Baseline Results
|
AffloVest Arm
n=10 Participants
Devices placed on highest intensity / highest frequency
Hill-Rom The Vest: High-frequency chest wall oscillation vest
|
Compressor Arm
n=10 Participants
Devices placed on highest intensity / highest frequency
Compressor-type device
|
|---|---|---|---|
|
FEV1
|
3.51 L
Interval 2.05 to 5.54
|
3.46 L
Interval 2.0 to 6.19
|
3.30 L
Interval 1.92 to 5.83
|
PRIMARY outcome
Timeframe: 30 minutesForced Expiratory Flow (25-75%), the peak expiratory flow at 25 - 75% FVC
Outcome measures
| Measure |
Baseline
n=10 Participants
Patient Baseline Results
|
AffloVest Arm
n=10 Participants
Devices placed on highest intensity / highest frequency
Hill-Rom The Vest: High-frequency chest wall oscillation vest
|
Compressor Arm
n=10 Participants
Devices placed on highest intensity / highest frequency
Compressor-type device
|
|---|---|---|---|
|
FEF25-75%
|
3.71 L/s
Interval 1.77 to 6.43
|
3.54 L/s
Interval 1.63 to 6.37
|
3.19 L/s
Interval 1.19 to 6.22
|
Adverse Events
AffloVest The Vest Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AffloVest inCourage Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AffloVest SmartVest Arm
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
VP of Engineering and Quality
International Biophysics Corporation
Phone: 512-814-0046
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place