HFCWO in Hospitalized Asthmatic Children - Full Text View

Sponsored by:	Hill-Rom
Information provided by:	Hill-Rom
ClinicalTrials.gov Identifier:	NCT00722020

Purpose

To determine whether or not high frequency chest wall oscillation (in the form of the VestTM) is superior to regular asthma therapy in the management of children hospitalized with moderate to severe asthma.

Condition	Intervention
Bronchial Asthma Asthma Status Asthmaticus	Device: High Frequency Chest Wall Oscillation via Vest (Hill-Rom Vest(tm)) Device: Regular nebulized bronchodilator treatment.

MedlinePlus related topics: Asthma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	High Frequency Chest Wall Oscillation in Hospital Management of Asthmatic Children

Further study details as provided by Hill-Rom:

Primary Outcome Measures:

The primary endpoint will be time to readiness for discharge. [ Time Frame: Hospital days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary endpoint total length of hospital stay. [ Time Frame: Days ] [ Designated as safety issue: No ]
Duration and number of doses of bronchodilator therapy [ Time Frame: Day ] [ Designated as safety issue: No ]

Estimated Enrollment:	220
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Patients will receive HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment.	Device: High Frequency Chest Wall Oscillation via Vest (Hill-Rom Vest(tm)) Simultaneous to bronchodilator treatment via nebulizer (regular treatment), patients will receive 15 minutes of HFCWO via the Vest.
2: Sham Comparator Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.	Device: Regular nebulized bronchodilator treatment. Sham Vest treatment.

Eligibility

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

Criteria

Inclusion Criteria:

Any pediatric patient between the ages of 18 months and 18 years admitted to Winthrop University Hospital's pediatric floor or intensive care unit with a diagnosis of asthma or reactive airway disease

Exclusion Criteria:

Patients with chronic, comorbid respiratory conditions (e.g., cerebral palsy, cystic fibrosis)
Those who regularly use HFCWO
Any patient exhibiting an absolute contraindication to HFCWO therapy
Absolute contraindications to using HFCWO include head and neck injury prior to stabilization, and active hemorrhage with hemodynamic instability

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722020

Locations

United States, New York
Winthrop University Hospital, Winthrop Pediatric Associates
Long Island, New York, United States, 11501
Winthrop University Hospital
Long Island, New York, United States, 11501

Sponsors and Collaborators

Hill-Rom

More Information

Responsible Party:	Winthrop Pediatric Associates ( Jon Roberts MD, PI )
Study ID Numbers:	CR-0078
Study First Received:	July 23, 2008
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00722020
Health Authority:	United States: Institutional Review Board

Keywords provided by Hill-Rom:

Asthma
Bronchial Disease
Status Asthmaticus

High Frequency Chest Wall Oscillation
the Vest
HFCWO

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Status Asthmaticus
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009