Study Assessing High-Frequency Chest Wall Oscillation (HFCWO) in Preventing Pulmonary Exacerbations
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|ClinicalTrials.gov Identifier: NCT00739310|
Recruitment Status : Completed
First Posted : August 21, 2008
Results First Posted : September 24, 2015
Last Update Posted : August 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Device: Vest Treatment (high frequency chest wall oscillation)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||July 2011|
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
- Hospitalizations Lasting at Least 24 Hours in This Patient Population [ Time Frame: end of study ]Hospitalizations lasting at least 24 hours
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
|United States, New York|
|Maimonides Medical Center|
|Brooklyn, New York, United States, 11219|
|Principal Investigator:||Mikail Kazachkov, MD||Maimonides Medical Center|