N/A Completed N=29 Prevention

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

Source: ClinicalTrials.gov NCT00739310 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2015

Primary outcomePrimary: Hospitalizations Lasting at Least 24 Hours in This Patient Population — 10; 8 hospitalizations

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Hospitalizations Lasting at Least 24 Hours in This Patient Population	10; 8	—

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00739310). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.