Trial Outcomes & Findings for Effect of HFCWO Vests on Spirometry Measurements (NCT NCT03628456)

Results Overview

Tidal Volume is the normal volume of air displaced between normal inhalation and exhalation, measured using standard sprirometry techniques

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

30 minutes

Results posted on

2019-11-22

Participant Flow

Participant milestones

Participant milestones
Measure	AffloVest Monarch Arm Devices placed on highest intensity / highest frequency International Biophysics AffloVest: High-frequency chest wall oscillation vest Hill-Rom Monarch: High-frequency chest wall oscillation vest
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AffloVest Monarch Arm n=10 Participants Devices placed on highest intensity / highest frequency International Biophysics AffloVest: High-frequency chest wall oscillation vest Hill-Rom Monarch: High-frequency chest wall oscillation vest
Age, Categorical <=18 years	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=10 Participants
Sex: Female, Male Female	5 Participants n=10 Participants
Sex: Female, Male Male	5 Participants n=10 Participants
Region of Enrollment United States	10 Participants n=10 Participants

PRIMARY outcome

Timeframe: 30 minutes

Tidal Volume is the normal volume of air displaced between normal inhalation and exhalation, measured using standard sprirometry techniques

Outcome measures

Outcome measures
Measure	Baseline n=10 Participants Patient baseline result	AffloVest Arm n=10 Participants AffloVest placed on subject at highest intensity for five (5) minutes	Monarch Arm n=10 Participants Monarch placed on subject at highest intensity for five (5) minutes
Tidal Volume (TV) Assessed in Participants at Baseline and With Both Devices	0.79 L Interval 0.36 to 1.87	0.93 L Interval 0.34 to 2.47	1.12 L Interval 0.38 to 2.24

PRIMARY outcome

Timeframe: 30 minutes

Peak Expiratory Flow (PEF) measures the peak flow during a forced exhalation, measured using standard spirometry techniques

Outcome measures

Outcome measures
Measure	Baseline n=10 Participants Patient baseline result	AffloVest Arm n=10 Participants AffloVest placed on subject at highest intensity for five (5) minutes	Monarch Arm n=10 Participants Monarch placed on subject at highest intensity for five (5) minutes
Peak Expiratory Flow (PEF) Assessed in Participants at Baseline and With Both Devices	7.08 L/s Interval 4.39 to 10.62	7.09 L/s Interval 4.38 to 10.32	7.68 L/s Interval 4.85 to 11.16

PRIMARY outcome

Timeframe: 30 minutes

Forced Vital Capacity (FVC) is the total amount of air exhaled during the FEV test, measured using standard spirometry techniques

Outcome measures

Outcome measures
Measure	Baseline n=10 Participants Patient baseline result	AffloVest Arm n=10 Participants AffloVest placed on subject at highest intensity for five (5) minutes	Monarch Arm n=10 Participants Monarch placed on subject at highest intensity for five (5) minutes
Forced Vital Capacity (FVC) Assessed in Participants at Baseline and With Both Devices	3.82 L Interval 2.61 to 5.45	3.70 L Interval 2.48 to 5.45	3.83 L Interval 2.77 to 5.04

PRIMARY outcome

Timeframe: 30 minutes

Forced Expiratory Volume in 1 second (FEV1) measures how much air a person can exhale during a forced breath during the first one (1) second, measured using standard spirometry techniques

Outcome measures

Outcome measures
Measure	Baseline n=10 Participants Patient baseline result	AffloVest Arm n=10 Participants AffloVest placed on subject at highest intensity for five (5) minutes	Monarch Arm n=10 Participants Monarch placed on subject at highest intensity for five (5) minutes
Forced Expiratory Volume (1 Second) Assessed in Participants at Baseline and With Both Devices	3.18 L Interval 2.15 to 4.73	3.04 L Interval 2.03 to 4.66	3.09 L Interval 2.23 to 4.33

PRIMARY outcome

Timeframe: 30 minutes

Forced Expiratory Flow (25-75%) is the average flow from the point at which 25% of the FVC has been exhaled to the point at which 75% of the FVC has been exhaled, measured using standard spirometry techniques

Outcome measures

Outcome measures
Measure	Baseline n=10 Participants Patient baseline result	AffloVest Arm n=10 Participants AffloVest placed on subject at highest intensity for five (5) minutes	Monarch Arm n=10 Participants Monarch placed on subject at highest intensity for five (5) minutes
Forced Expiratory Flow (FEF25-75%) Assessed in Participants at Baseline and With Both Devices	3.37 L/s Interval 2.24 to 5.06	3.08 L/s Interval 1.85 to 4.9	3.05 L/s Interval 2.24 to 4.54

Adverse Events

Baseline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AffloVest Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Monarch 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: 512-804-0046

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place