Effect of HFCWO Vests on Spirometry Measurements
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Bronchitis, Pulmonary, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 9/12/2018 |
| Start Date: | September 2018 |
| End Date: | December 2018 |
Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements, Comparative Study
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
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
The study will be broken into one (1) arm:
• AffloVest® & Monarch™
Within the arm, the order of products will be randomized.
Baseline spirometry (Forced Expiratory Volume (FEV1), Forced Vital Capacity (FVC), Peak
Expiratory Flow (PEF), Forced Expiratory Flow (FEF25-75%) and Tidal Volume (TV)) will be
taken at the beginning, middle and end of each series of measurements with each subject,
without any device on the subject. A product (AffloVest or Monarch) will be placed onto
subject and turned ON to the highest frequency and intensity settings. Then the subject will
be given a certain period of time to adjust and spirometry measurements will then be
repeated, then the product will be removed and the subject will be allowed a recovery period,
then the other product will be placed on the subject, turned ON and spirometry measurements
will repeated.
• AffloVest® & Monarch™
Within the arm, the order of products will be randomized.
Baseline spirometry (Forced Expiratory Volume (FEV1), Forced Vital Capacity (FVC), Peak
Expiratory Flow (PEF), Forced Expiratory Flow (FEF25-75%) and Tidal Volume (TV)) will be
taken at the beginning, middle and end of each series of measurements with each subject,
without any device on the subject. A product (AffloVest or Monarch) will be placed onto
subject and turned ON to the highest frequency and intensity settings. Then the subject will
be given a certain period of time to adjust and spirometry measurements will then be
repeated, then the product will be removed and the subject will be allowed a recovery period,
then the other product will be placed on the subject, turned ON and spirometry measurements
will repeated.
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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