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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00739310
• Other study ID #: CR-0088
• Status: Completed
• Phase: N/A
• First received: August 20, 2008
• Last updated: August 24, 2015
• Start date: August 2008
• Est. completion date: July 2011

Study information

• Verified date: August 2015
• Source: Hill-Rom
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: July 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Months to 18 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Device:
• Vest Treatment (high frequency chest wall oscillation)
twice daily for 15-20 minutes

Locations

Country	Name	City	State
United States	Maimonides Medical Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hill-Rom

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalizations Lasting at Least 24 Hours in This Patient Population	Hospitalizations lasting at least 24 hours	end of study	No