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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Device: Vest Treatment (high frequency chest wall oscillation)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is at least 18 months old. Subject has a chest circumference of greater than 19 inches. Subject has a diagnosis of muscle weakness and restrictive lung disease. Ability to provide Informed consent from legal guardian. Subject has had 2 or more exacerbations requiring either hospitalization or antibiotics (IV or oral) in the past 12 months If inhaled Tobramycin has been prescribed prophylacticly, subjects must discontinue the medication at least 2 weeks prior to study enrollment Exclusion Criteria: Subject has a diagnosed allergy with a respiratory trigger. Participation in another clinical trial. Unstable head or spinal injury. Unresolved pneumothorax or pneumomediastinum present Unresolved hemorrhage Hypotension requiring vasopressors or positioning Bronchopleural fistula Gross hemoptysis within the past eight hours Pulmonary embolism or history of pulmonary embolism within the past two months Burns, open wounds and skin infections on the thorax Osteomyelitis of the ribs Osteoporosis with history of fractures.

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vest Treatment (HFCWO)<br>Patients will receive Vest treatments for airway clearance therapy 2 x daily for 12 months. These data will be compared to 12 months of data prior to Vest initiation. | Device: Vest Treatment (high frequency chest wall oscillation)<br>* twice daily for 15-20 minutes<br>* Other names: HFCWO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalizations Lasting at Least 24 Hours in This Patient Population | Hospitalizations lasting at least 24 hours | end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High Frequency Chest Wall Oscillation, Cerebral Palsy, Restrictive lung disease