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

This study has been completed.
Information provided by (Responsible Party):
Hill-Rom Identifier:
First received: August 20, 2008
Last updated: August 24, 2015
Last verified: August 2015
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.

Condition Intervention
Cerebral Palsy
Device: Vest Treatment (high frequency chest wall oscillation)

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

Resource links provided by NLM:

Further study details as provided by Hill-Rom:

Primary Outcome Measures:
  • Hospitalizations Lasting at Least 24 Hours in This Patient Population [ Time Frame: end of study ] [ Designated as safety issue: No ]
    Hospitalizations lasting at least 24 hours

Enrollment: 29
Study Start Date: August 2008
Study Completion Date: July 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Device: Vest Treatment (high frequency chest wall oscillation)
twice daily for 15-20 minutes
Other Name: HFCWO

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.


Ages Eligible for Study:   18 Months to 18 Years
Genders Eligible for Study:   Both
Accepts 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00739310

United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Sponsors and Collaborators
Principal Investigator: Mikail Kazachkov, MD Maimonides Medical Center
  More Information

No publications provided

Responsible Party: Hill-Rom Identifier: NCT00739310     History of Changes
Other Study ID Numbers: CR-0088
Study First Received: August 20, 2008
Results First Received: April 20, 2015
Last Updated: August 24, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Hill-Rom:
High Frequency Chest Wall Oscillation
Cerebral Palsy
Restrictive lung disease

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on November 25, 2015