N/A
Completed N=10
Effect of HFCWO Vests on Spirometry Measurements
Source: ClinicalTrials.gov NCT03628456 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Tidal Volume (TV) Assessed in Participants at Baseline and With Both Devices — 0.79; 0.93; 1.12 L
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
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 | — |
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
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. Informational only — not medical advice.