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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hill-Rom
ClinicalTrials.gov Identifier:
NCT00739310
First received: August 20, 2008
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
  Purpose

To demonstrate that airway clearance provided by Vest therapy reduces the frequency 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)
Procedure: Manual Chest physiotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel 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:

U.S. FDA Resources

Further study details as provided by Hill-Rom:

Primary Outcome Measures:
  • Rate of hospitalizations [ Time Frame: end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amount of Antibiotics Cost of Treatment [ Time Frame: End of study ] [ Designated as safety issue: No ]

Enrollment: 43
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
Experimental: 1
Patients will receive Vest treatments for chest clearance
 Device: Vest Treatment (high frequency chest wall oscillation)
twice daily for 15-20 minutes
Other Name: HFCWO
Active Comparator: 2
Patients will undergo manual CPT for chest clearance
 Procedure: Manual Chest physiotherapy
Twice daily for 15 minutes
Other Name: Manual CPT

Detailed Description:

The study is designed as an open label randomized study. The study will compare the efficacy and effectiveness of manual chest physiotherapy to Vest® therapy 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 60, with a 2:1 randomization between experimental and control groups. Subjects will be considered evaluable if they have completed at least 6 months of follow up. Subjects who withdraw, up to a maximum of 10 will be replaced

  Eligibility

Ages Eligible for Study:   18 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00739310

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

No publications provided

Responsible Party: Hill-Rom
ClinicalTrials.gov Identifier: NCT00739310     History of Changes
Other Study ID Numbers: CR-0088
Study First Received: August 20, 2008
Last Updated: March 20, 2012
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
Lung Diseases
Brain Damage, Chronic
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013