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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00739310
First Posted: August 21, 2008
Last Update Posted: August 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hill-Rom
  Purpose
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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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
Experimental: 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hill-Rom
ClinicalTrials.gov Identifier: NCT00739310     History of Changes
Other Study ID Numbers: CR-0088
First Submitted: August 20, 2008
First Posted: August 21, 2008
Results First Submitted: April 20, 2015
Results First Posted: September 24, 2015
Last Update Posted: August 7, 2017
Last Verified: July 2017

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