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Sponsored by: |
Hill-Rom |
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Information provided by: | Hill-Rom |
ClinicalTrials.gov Identifier: | NCT00722020 |
To determine whether or not high frequency chest wall oscillation (in the form of the VestTM) is superior to regular asthma therapy in the management of children hospitalized with moderate to severe asthma.
Condition | Intervention |
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Bronchial Asthma Asthma Status Asthmaticus |
Device: High Frequency Chest Wall Oscillation via Vest (Hill-Rom Vest(tm)) Device: Regular nebulized bronchodilator treatment. |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | High Frequency Chest Wall Oscillation in Hospital Management of Asthmatic Children |
Estimated Enrollment: | 220 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Patients will receive HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment.
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Device: High Frequency Chest Wall Oscillation via Vest (Hill-Rom Vest(tm))
Simultaneous to bronchodilator treatment via nebulizer (regular treatment), patients will receive 15 minutes of HFCWO via the Vest.
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2: Sham Comparator
Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.
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Device: Regular nebulized bronchodilator treatment.
Sham Vest treatment.
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Ages Eligible for Study: | 18 Months to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Winthrop University Hospital, Winthrop Pediatric Associates | |
Long Island, New York, United States, 11501 | |
Winthrop University Hospital | |
Long Island, New York, United States, 11501 |
Responsible Party: | Winthrop Pediatric Associates ( Jon Roberts MD, PI ) |
Study ID Numbers: | CR-0078 |
Study First Received: | July 23, 2008 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00722020 History of Changes |
Health Authority: | United States: Institutional Review Board |
Asthma Bronchial Disease Status Asthmaticus |
High Frequency Chest Wall Oscillation the Vest HFCWO |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Bronchial Diseases Lung Diseases Status Asthmaticus |
Hypersensitivity, Immediate Anti-Asthmatic Agents Asthma Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Respiratory System Agents Bronchial Diseases Immune System Diseases Status Asthmaticus Physiological Effects of Drugs Anti-Asthmatic Agents Asthma Pharmacologic Actions Lung Diseases, Obstructive |
Hypersensitivity Respiratory Tract Diseases Autonomic Agents Therapeutic Uses Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |