Bronchiectasis, Cystic Fibrosis
Conditions
Brief 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
Detailed description
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.
Interventions
High-frequency chest wall oscillation vest
DEVICEHill-Rom Monarch
High-frequency chest wall oscillation vest
Sponsors
International Biophysics Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tidal Volume (TV) Assessed in Participants at Baseline and With Both Devices | 30 minutes | Tidal Volume is the normal volume of air displaced between normal inhalation and exhalation, measured using standard sprirometry techniques |
| Peak Expiratory Flow (PEF) Assessed in Participants at Baseline and With Both Devices | 30 minutes | Peak Expiratory Flow (PEF) measures the peak flow during a forced exhalation, measured using standard spirometry techniques |
| Forced Vital Capacity (FVC) Assessed in Participants at Baseline and With Both Devices | 30 minutes | Forced Vital Capacity (FVC) is the total amount of air exhaled during the FEV test, measured using standard spirometry techniques |
| Forced Expiratory Volume (1 Second) Assessed in Participants at Baseline and With Both Devices | 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 |
| Forced Expiratory Flow (FEF25-75%) Assessed in Participants at Baseline and With Both Devices | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | AffloVest Monarch Arm | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 10 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 10 Participants | — |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Forced Expiratory Flow (FEF25-75%) Assessed in Participants at Baseline and With Both Devices
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
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Baseline | Forced Expiratory Flow (FEF25-75%) Assessed in Participants at Baseline and With Both Devices | 3.37 L/s |
| AffloVest Arm | Forced Expiratory Flow (FEF25-75%) Assessed in Participants at Baseline and With Both Devices | 3.08 L/s |
| Monarch Arm | Forced Expiratory Flow (FEF25-75%) Assessed in Participants at Baseline and With Both Devices | 3.05 L/s |
Primary
Forced Expiratory Volume (1 Second) Assessed in Participants at Baseline and With Both Devices
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
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Baseline | Forced Expiratory Volume (1 Second) Assessed in Participants at Baseline and With Both Devices | 3.18 L |
| AffloVest Arm | Forced Expiratory Volume (1 Second) Assessed in Participants at Baseline and With Both Devices | 3.04 L |
| Monarch Arm | Forced Expiratory Volume (1 Second) Assessed in Participants at Baseline and With Both Devices | 3.09 L |
Primary
Forced Vital Capacity (FVC) Assessed in Participants at Baseline and With Both Devices
Forced Vital Capacity (FVC) is the total amount of air exhaled during the FEV test, measured using standard spirometry techniques
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Baseline | Forced Vital Capacity (FVC) Assessed in Participants at Baseline and With Both Devices | 3.82 L |
| AffloVest Arm | Forced Vital Capacity (FVC) Assessed in Participants at Baseline and With Both Devices | 3.70 L |
| Monarch Arm | Forced Vital Capacity (FVC) Assessed in Participants at Baseline and With Both Devices | 3.83 L |
Primary
Peak Expiratory Flow (PEF) Assessed in Participants at Baseline and With Both Devices
Peak Expiratory Flow (PEF) measures the peak flow during a forced exhalation, measured using standard spirometry techniques
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Baseline | Peak Expiratory Flow (PEF) Assessed in Participants at Baseline and With Both Devices | 7.08 L/s |
| AffloVest Arm | Peak Expiratory Flow (PEF) Assessed in Participants at Baseline and With Both Devices | 7.09 L/s |
| Monarch Arm | Peak Expiratory Flow (PEF) Assessed in Participants at Baseline and With Both Devices | 7.68 L/s |
Primary
Tidal Volume (TV) Assessed in Participants at Baseline and With Both Devices
Tidal Volume is the normal volume of air displaced between normal inhalation and exhalation, measured using standard sprirometry techniques
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Baseline | Tidal Volume (TV) Assessed in Participants at Baseline and With Both Devices | 0.79 L |
| AffloVest Arm | Tidal Volume (TV) Assessed in Participants at Baseline and With Both Devices | 0.93 L |
| Monarch Arm | Tidal Volume (TV) Assessed in Participants at Baseline and With Both Devices | 1.12 L |