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

NCT ID: NCT00739310

Last Updated: 2017-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2011-07-31

Brief Summary

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.

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Vest Treatment (high frequency chest wall oscillation)

Intervention Type: DEVICE

twice daily for 15-20 minutes

Interventions

Vest Treatment (high frequency chest wall oscillation)

twice daily for 15-20 minutes

Intervention Type: DEVICE

Other Intervention Names

HFCWO

Eligibility 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.

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hill-Rom

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mikail Kazachkov, MD

Role: PRINCIPAL_INVESTIGATOR

Maimonides Medical Center

Locations

Maimonides Medical Center

Brooklyn, New York, United States

Countries

United States

Other Identifiers

CR-0088

Identifier Type: -

Identifier Source: org_study_id