Effect of HFCWO Vests on Spirometry Measurements

International Biophysics Corporation10 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis Bronchiectasis

Interventions

International Biophysics AffloVestDEVICE

High-frequency chest wall oscillation vest

Hill-Rom MonarchDEVICE

High-frequency chest wall oscillation vest

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

PDS Research

Kissimmee, Florida, United States

Outcomes

Primary Outcomes

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

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

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

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

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

Data from ClinicalTrials.gov

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