Effect of HFCWO Vests on Spirometry Measurements

Cystic Fibrosis Clinical Trial

Official title:

Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements, Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03628456
• Other study ID #: 2018-01
• Status: Completed
• Phase: N/A
• Start date: September 13, 2018
• Est. completion date: July 2, 2019

Study information

• Verified date: November 2019
• Source: International Biophysics Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2, 2019
• Est. primary completion date: September 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis
• Cystic Fibrosis

Intervention

Device:
• International Biophysics AffloVest
High-frequency chest wall oscillation vest
• Hill-Rom Monarch
High-frequency chest wall oscillation vest

Locations

Country	Name	City	State
United States	PDS Research	Kissimmee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
International Biophysics Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	30 minutes
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	30 minutes
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	30 minutes
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	30 minutes
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	30 minutes