Expired Study
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Brooklyn, New York 11219


Purpose:

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.


Study summary:

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


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.


NCT ID:

NCT00739310


Primary Contact:

Principal Investigator
Mikail Kazachkov, MD
Maimonides Medical Center


Backup Contact:

N/A


Location Contact:

Brooklyn, New York 11219
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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