Status:
COMPLETED
Study Assessing High-Frequency Chest Wall Oscillation (HFCWO) in Preventing Pulmonary Exacerbations
Lead Sponsor:
Hill-Rom
Conditions:
Cerebral Palsy
Eligibility:
All Genders
18-18 years
Phase:
NA
Brief Summary
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 weakn...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00739310
Start Date
August 1 2008
End Date
July 1 2011
Last Update
August 7 2017
Active Locations (1)
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1
Maimonides Medical Center
Brooklyn, New York, United States, 11219