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

Sponsored by:	Hill-Rom
Information provided by:	Hill-Rom
ClinicalTrials.gov Identifier:	NCT00739310

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.

Condition	Intervention
Cerebral Palsy	Device: Vest Treatment (high frequency chest wall oscillation) Procedure: Manual Chest physiotherapy

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cerebral Palsy Paralysis

U.S. FDA Resources

Further study details as provided by Hill-Rom:

Primary Outcome Measures:

Rate of hospitalizations [ Time Frame: end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Amount of Antibiotics Cost of Treatment [ Time Frame: End of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	August 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patients will receive Vest treatments for chest clearance	Device: Vest Treatment (high frequency chest wall oscillation) twice daily for 15-20 minutes
2: Active Comparator Patients will undergo manual CPT for chest clearance	Procedure: Manual Chest physiotherapy Twice daily for 15 minutes

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Months to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739310

Locations

United States, New York
Maimonides Medical Center	Recruiting
Brooklyn, New York, United States, 11219
Contact: Mikhail Kazachkov, MD 718-283-6251 mkazachkov@maimonidesmed.org
Contact: Kathyrn Fitzgerald, CPNP 718-283-6251 kfitzgerald@maimonidesmed.org
Principal Investigator: Mikhail Kazachkov, MD
Sub-Investigator: Kathryn Fitzgerald, CPNP
Sub-Investigator: Jessica Dugre, CPNP

Sponsors and Collaborators

Hill-Rom

Investigators

Principal Investigator:

Mikail Kazachkov, MD

Maimonides Medical Center

More Information

No publications provided

Responsible Party:	Maimonides Medical Center ( Mikhail Kazachkov, MD, Director Pulmonary Bronchoscopy )
Study ID Numbers:	CR-0088
Study First Received:	August 20, 2008
Last Updated:	August 27, 2008
ClinicalTrials.gov Identifier:	NCT00739310 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Hill-Rom:

High Frequency Chest Wall Oscillation
Cerebral Palsy
Restrictive lung disease

Study placed in the following topic categories:

Paralysis
Cerebral Palsy
Asthenia
Lung Diseases
Brain Damage, Chronic

Central Nervous System Diseases
Brain Diseases
Brain Injuries
Muscle Weakness

Additional relevant MeSH terms:

Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Central Nervous System Diseases
Brain Diseases

ClinicalTrials.gov processed this record on September 11, 2009