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

August 20, 2008
March 20, 2012
August 2008
October 2010   (final data collection date for primary outcome measure)
Rate of hospitalizations [ Time Frame: end of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00739310 on ClinicalTrials.gov Archive Site
Amount of Antibiotics Cost of Treatment [ Time Frame: End of study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study Assessing High-Frequency Chest Wall Oscillation (HFCWO) in Preventing Pulmonary Exacerbations
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

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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Cerebral Palsy
  • Device: Vest Treatment (high frequency chest wall oscillation)
    twice daily for 15-20 minutes
    Other Name: HFCWO
  • Procedure: Manual Chest physiotherapy
    Twice daily for 15 minutes
    Other Name: Manual CPT
  • Experimental: 1
    Patients will receive Vest treatments for chest clearance
    Intervention: Device: Vest Treatment (high frequency chest wall oscillation)
  • Active Comparator: 2
    Patients will undergo manual CPT for chest clearance
    Intervention: Procedure: Manual Chest physiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
July 2011
October 2010   (final data collection date for primary outcome measure)

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.
Both
18 Months to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00739310
CR-0088
No
Hill-Rom
Hill-Rom
Not Provided
Principal Investigator: Mikail Kazachkov, MD Maimonides Medical Center
Hill-Rom
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP