Effect of HFCWO Vests on Spirometry Measurements

International Biophysics

Status: Completed

Conditions: Bronchiectasis; Cystic Fibrosis

Treatments: Device: Hill-Rom Monarch; Device: International Biophysics AffloVest

Study type: Interventional

Funder types: Industry

Identifiers

NCT03628456

2018-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

AffloVest Monarch Arm

Experimental group

Description:

Devices placed on highest intensity / highest frequency

Treatment:

Device: Hill-Rom Monarch

Device: International Biophysics AffloVest