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

NCT00739310 | Completed Results

• 1 other identifier: CR-0088
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

High Frequency Chest Wall Oscillation; Cerebral Palsy; Restrictive lung disease

Outcome Measures

Primary Outcomes (1)

• Hospitalizations Lasting at Least 24 Hours in This Patient Population

  Hospitalizations lasting at least 24 hours

  end of study

Study Arms (1)

Vest Treatment (HFCWO)

EXPERIMENTAL

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)

Interventions

Vest Treatment (high frequency chest wall oscillation) DEVICE

twice daily for 15-20 minutes

Also known as: HFCWO

Vest Treatment (HFCWO)

Eligibility Criteria

• Age: 18 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hill-Rom: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Chest Wall Oscillation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics

Limitations and Caveats

Study design was sub-optimal due to lack of control group and lack of randomization

Results Point of Contact

• Title: Kathryn Fitzgerald, NP
• Organization: Maimonides, Department of Pulmonary Medicine

kfitzgerald@maimonidesmed.org

718-283-7339

Study Officials

• Mikail Kazachkov, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2008
• First Posted: August 21, 2008
• Study Start: August 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: July 1, 2011
• Last Updated: August 7, 2017
• Results First Posted: September 24, 2015

Record last verified: 2017-07

Locations

US (1)