Effect of HFCWO Vests on Spirometry Measurements

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

Study Overview

• Status: Completed
• Conditions: Bronchiectasis; Cystic Fibrosis
• Intervention / Treatment: Device: International Biophysics AffloVest; Device: Hill-Rom Monarch

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Kissimmee, Florida, United States, 34741
      • PDS Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AffloVest Monarch Arm; Devices placed on highest intensity / highest frequency	Device: International Biophysics AffloVest; High-frequency chest wall oscillation vest; Device: Hill-Rom Monarch; High-frequency chest wall oscillation vest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: International Biophysics Corporation
• Investigators: Principal Investigator: Thomas W O'Brien, MD, PDS Research

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2018
• Primary Completion (Actual): September 21, 2018
• Study Completion (Actual): July 2, 2019

Study Registration Dates

• First Submitted: August 9, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): November 22, 2019
• Last Update Submitted That Met QC Criteria: November 13, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Bronchial Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Bronchiectasis; Cystic Fibrosis
• Other Study ID Numbers: 2018-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No