N/A N=10 Treatment

Effect of HFCWO Vests on Spirometry Measurements

Cystic Fibrosis · Bronchiectasis

Bottom Line

View on ClinicalTrials.gov: NCT03628456 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2019

Primary outcome: Primary: Tidal Volume (TV) Assessed in Participants at Baseline and With Both Devices — 0.79; 0.93; 1.12 L

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: International Biophysics AffloVest (Device); Hill-Rom Monarch (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: International Biophysics Corporation
Primary completion: Sep 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Tidal Volume (TV) Assessed in Participants at Baseline and With Both Devices	0.79; 0.93; 1.12	—
PRIMARY Peak Expiratory Flow (PEF) Assessed in Participants at Baseline and With Both Devices	7.08; 7.09; 7.68	—
PRIMARY Forced Vital Capacity (FVC) Assessed in Participants at Baseline and With Both Devices	3.82; 3.70; 3.83	—
PRIMARY Forced Expiratory Volume (1 Second) Assessed in Participants at Baseline and With Both Devices	3.18; 3.04; 3.09	—
PRIMARY Forced Expiratory Flow (FEF25-75%) Assessed in Participants at Baseline and With Both Devices	3.37; 3.08; 3.05	—

Summary

The impact of high-frequency chest wall oscillation therapy on spirometry values (Forced Expiratory Volume, Forced Vital Capacity, Peak Expiratory Flow, Forced Expiratory Flow and Tidal Volume is investigated during use of several products and comparing to baseline values

Eligibility Criteria

Inclusion Criteria

Healthy subject, ages 18 - 50

Exclusion Criteria

Non-ambulatory
diagnosed neuromuscular disorder
currently using any type of oscillation vest therapy
diagnosed co-morbid condition (i.e. lung cancer, other lung disorder or disease)
currently enrolled in a medical research study
non-English speaking
presence of the following active implantable devices: pacemakers, neurostimulators, infusion pumps, circulatory support devices, implantable cardioverter defibrillators (ICD's), cochlear implants
presence of head and/or neck injury that has not yet been stabilized
presence of active hemorrhage with hemodynamic instability

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Data sourced from ClinicalTrials.gov (NCT03628456). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.