- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00739310
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Brooklyn, New York, United States, 11219
- Maimonides Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
twice daily for 15-20 minutes
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospitalizations Lasting at Least 24 Hours in This Patient Population
Time Frame: end of study
|
Hospitalizations lasting at least 24 hours
|
end of study
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mikail Kazachkov, MD, Maimonides Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR-0088
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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