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A Pilot Study to Assess the Efficacy and Effectiveness of High-Frequency Chest Wall Oscillation (HFCWO) in Preventing Pulmonary Exacerbations in Children With Muscle Weakness and Restrictive Lung Disease CR-0088
To asssess efficacy of airway clearance provided by Vest therapy (HFCWO) in the reduction of respiratory exacerbations requiring hospitalization or antibiotic utilization in patients with muscle weakness and restrictive lung disease.
This non-randomized home based pre-post intervention study. The study will compare the efficacy of Vest® therapy (HFCWO) for mucus secretion clearance in a population of patients with muscle weakness and restrictive lung disease with frequent pulmonary exacerbations. Enrolled subjects with a tracheostomy will be evaluated for microbial load and inflammatory status as a pilot evaluation of microbial load and inflammatory status outcomes. The total number of evaluable subjects to be recruited is estimated at 40. Subjects will be considered evaluable if they have completed at least 6 months of follow up.
Age
1 - 18 years
Sex
ALL
Healthy Volunteers
No
Maimonides Medical Center
Brooklyn, New York, United States
Start Date
August 1, 2008
Primary Completion Date
October 1, 2010
Completion Date
July 1, 2011
Last Updated
August 7, 2017
29
ACTUAL participants
Vest Treatment (high frequency chest wall oscillation)
DEVICE
Lead Sponsor
Hill-Rom
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07168577