Advertisement

Topics

A Pilot Study to Evaluate the Use of the Vest® System for Treatment of Bronchiectasis Patients in the Home Setting

2019-07-16 10:38:33 | BioPortfolio

Summary

This a 70 patient multi-site non blinded randomized control trial evaluating the use of the Vest® System for treatment of Non-Cystic Fibrosis Bronchiectasis (NCFBE) patients in the home setting. The study will assess outcomes in subjects requiring airway clearance therapy randomized to Oscillating Positive Expiratory Pressure (OPEP) therapy as the control group and High Frequency Chest Wall Oscillation (HFCWO) therapy as the intervention group

Description

Patients with NCFBE who require regular home airway clearance therapy will be eligible to be screened for inclusion in the study.

After enrollment, baseline data including demographics, pulmonary related medical history including acute exacerbations (pulmonary-related hospitalizations, ED visits and physician office visits) will be collected Pulmonary function tests (PFTs) (spirometry), and a six-minute walk test will be completed. Quality of Life measures and inflammatory markers and will be collected.

Patients will be randomized to HFCWO or OPEP therapy. Each device will be used within the approved product labeling. These will be the primary airway clearance devices for these patients during the 12 months of the study period.

Following enrollment in the study and completion of a baseline visit, subjects will be seen for follow-up visits.

Detailed documentation of health status and medical history will be collected during the 12-month study period and/or at each study visit to document the occurrence of acute exacerbations and to determine time to first exacerbation, number of hospitalizations and hospitalization days, number of ICU admissions and ICU days, and number of outpatient visits (Physician's office visit, Urgent Care Visits, ED visits)

At 3 months, 6 months and 12 months following the baseline visit, the following tests/procedures will be performed. At each follow-up study visit:

- Acute exacerbations that occurred during the prior 3-month period will be documented/verified

- Pulmonary function will be assessed using standard spirometry to obtain FEV1, FVC and FEV1/FVC.

- 6-minute walk test will be completed to assess respiratory status and endurance

- The QoL-B quality of life survey will be conducted

- A sputum sample will be collected. Sputum samples will be transported to a central lab to test for inflammatory markers (sputum neutrophil elastase in μg/ml).

Mean adherence to the prescribed treatment regimen will be collected and assessed using the validated Modified Self-Reported Medication-Taking Scale. Adherence data in the HFCWO arm will also be collected via the VisiView patient portal.

Adherence results will be collected at the 3-month visit, 6-month visit and 12-month visits.

Any device related adverse events which occur after initial therapy with The Vest® System or Acapella therapy will be recorded.

Any equipment related complaints which occur after initial therapy with The Vest® System or Acapella therapy will be recorded.

At the end of the 12-month study period, subjects randomized to the PEP group will be given the option of receiving HFCWO therapy for a 6 month follow up period with outcomes data assessed at the 6-month time point.

Study Design

Conditions

Bronchiectasis

Intervention

High Frequency Chest Wall Oscillation, Oscillating Positive Expiratory Pressure (OPEP)

Status

Not yet recruiting

Source

Hill-Rom

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-07-16T10:38:33-0400

Clinical Trials [1688 Associated Clinical Trials listed on BioPortfolio]

Airway Clearance Using High Frequency Chest Wall Oscillation

High frequency chest wall oscillation (HFCWO) has been shown to increase tracheal mucous clearance compared with control. These observations led to the development of 'The Vest' which is a...

Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements

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 Vo...

Airway Secretion Clearance in Cystic Fibrosis

The purpose of this study is to compare the effect of three airway secretion clearance techniques (chest physical therapy, flutter device and high frequency chest wall oscillation) on decl...

High Frequence Chest Wall Oscillation and Cystic Fibrosis

High frequency chest wall oscillation (HFCWO) has been shown to increase tracheal mucus clearance compared with a control group. These observations led to the development of The Vest® wh...

Study Assessing High-Frequency Chest Wall Oscillation (HFCWO) in Preventing Pulmonary Exacerbations

To demonstrate that airway clearance provided by Vest therapy reduces the frequency of respiratory exacerbations requiring hospitalization or antibiotic utilization in patients with muscle...

PubMed Articles [22920 Associated PubMed Articles listed on BioPortfolio]

Comparison of Endotracheal Reintubation between Nasal High-Frequency Oscillation and Continuous Positive Airway Pressure in Neonates.

 To compare the endotracheal reintubation between nasal high-frequency oscillation (nHFO) and nasal continuous positive airway pressure (nCPAP) with face mask groups who were followed up for up to 7...

Lung Recruitment in Obese Patients with Acute Respiratory Distress Syndrome.

Obesity increases the propensity to atelectasis in acute respiratory distress syndrome, but the optimal approach to reversing this atelectasis is uncertain WHAT THIS ARTICLE TELLS US THAT IS NEW: A cl...

Standard and viscoelastic mechanical properties of respiratory system compartments in dogs: effect of volume, posture, and shape.

In 9 anesthetized, paralyzed dogs lung and chest-wall standard (viscous resistance, Rint, and quasi-static elastance, Est) and viscoelastic parameters (resistance, Rvel, and time constant, τvel) were...

Three-Dimensional Printing for Chest Wall Reconstruction in Thoracic Surgery: Building on Experience.

 Patients undergoing surgery for locally advanced lung cancer involving the chest wall require anatomical lung with extensive en-bloc chest wall resection and appropriate reconstruction.In this proo...

Outcomes in Chest Wall Reconstruction Using Methyl Methacrylate Prostheses: A Review of the Literature and Case Series Utilizing a Novel Approach with Biologic Mesh.

 Composite defects after chest wall resection may leave patients at risk with lack of protection of vital structures and potentially respiratory compromise secondary to flail segments. Reconstructio...

Medical and Biotech [MESH] Definitions

A respiratory support system used to remove mucus and clear airway by oscillating pressure on the chest.

Ventilatory support system using frequencies from 60-900 cycles/min or more. Three types of systems have been distinguished on the basis of rates, volumes, and the system used. They are high frequency positive-pressure ventilation (HFPPV); HIGH-FREQUENCY JET VENTILATION; (HFJV); and high-frequency oscillation (HFO).

Non-therapeutic positive end-expiratory pressure occurring frequently in patients with severe airway obstruction. It can appear with or without the administration of external positive end-expiratory pressure (POSITIVE-PRESSURE RESPIRATION). It presents an important load on the inspiratory muscles which are operating at a mechanical disadvantage due to hyperinflation. Auto-PEEP may cause profound hypotension that should be treated by intravascular volume expansion, increasing the time for expiration, and/or changing from assist mode to intermittent mandatory ventilation mode. (From Harrison's Principles of Internal Medicine, 12th ed, p1127)

The measurement of frequency or oscillation changes.

Oscillating sound wave with a frequency higher than the upper limit of the human hearing range.

More From BioPortfolio on "A Pilot Study to Evaluate the Use of the Vest® System for Treatment of Bronchiectasis Patients in the Home Setting"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Pulmonary
Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza,  Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...


Searches Linking to this Trial