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 weakness and restrictive lung disease.

The study is designed as an open label randomized study. The study will compare the efficacy and effectiveness of manual chest physiotherapy to Vest® therapy 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 60, with a 2:1 randomization between experimental and control groups. Subjects will be considered evaluable if they have completed at least 6 months of follow up. Subjects who withdraw, up to a maximum of 10 will be replaced

• Device: Vest Treatment (high frequency chest wall oscillation)
  twice daily for 15-20 minutes
  Other Name: HFCWO
• Procedure: Manual Chest physiotherapy
  Twice daily for 15 minutes
  Other Name: Manual CPT

• Experimental: 1
  Patients will receive Vest treatments for chest clearance
  Intervention: Device: Vest Treatment (high frequency chest wall oscillation)
• Active Comparator: 2
  Patients will undergo manual CPT for chest clearance
  Intervention: Procedure: Manual Chest physiotherapy

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.