A Pilot Study to Evaluate the Use of the Vest® System for Treatment of Bronchiectasis Patients in the Home Setting
Reason given: Data
Key facts
- Where
- Nashville, New York, and Tyler, United StatesSee the 3 sites
Where in United States
- Tennessee Comprehensive Lung and Sleep CenterNashville, United StatesNo longer taking part
- NYU Langone HealthNew York, United StatesNo longer taking part
- UT Tyler Health Science CenterTyler, United StatesNo longer taking part
Trial details
- Who runs it
- Hill-Rom
- Trial code
- NCT04017312
- Record updated
- 21 August 2024
- Original description
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 groupRead full original descriptionShow less
Evaluation of HFCWO Using The Vest® System for Treatment of Non-Cystic Fibrosis Bronchiectasis in the Home Setting
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
Inclusion: Radiological diagnosis of Bronchiectasis based on high resolution chest CT scan; History of at least 2 acute exacerbations or hospitalizations in the past 12 months; Clinically stable for >2 weeks prior to study entry; FEV1 >30% predicted; Age18-80 years; Signed informed consent.
Exclusion: Patients currently on home HFCWO treatment or home HFCWO treatment within the past 24 months; Inability to perform HFCWO therapy or OPEP therapy as directed; History of bronchiectasis secondary to primary immunodeficiency; Active pulmonary tuberculosis; History of pneumothorax within past 6 months; History of hemoptysis requiring embolization within past 12 months; Diagnosis of Cystic Fibrosis; Active treatment of Non-Tuberculous Mycobacterium (NTM); Diagnosed comorbidity or medical indication that would prevent study completion; Pregnancy or lactation; Inability or unwillingness to complete study visits or provide follow-up data as required by the study protocol.