Cerebral Palsy
Conditions
Keywords
High Frequency Chest Wall Oscillation, Cerebral Palsy, Restrictive lung disease
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 weakness and restrictive lung disease.
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 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.
Interventions
DEVICEVest Treatment (high frequency chest wall oscillation)
twice daily for 15-20 minutes
Sponsors
Hill-Rom
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Months to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalizations Lasting at Least 24 Hours in This Patient Population | end of study | Hospitalizations lasting at least 24 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vest Treatment (HFCWO) 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.
Vest Treatment (high frequency chest wall oscillation): twice daily for 15-20 minutes | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Poor adherance to prescribed therapy | 4 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Vest Treatment (HFCWO) |
|---|---|
| Age, Continuous | 9.55 years STANDARD_DEVIATION 5.57 |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
Primary
Hospitalizations Lasting at Least 24 Hours in This Patient Population
Hospitalizations lasting at least 24 hours
Time frame: end of study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pre-Treatment | Hospitalizations Lasting at Least 24 Hours in This Patient Population | 10 hospitalizations |
| Post Vest Treatment | Hospitalizations Lasting at Least 24 Hours in This Patient Population | 8 hospitalizations |