HFCWO in Hospitalized Asthmatic Children - Full Text View

Sponsor:	Hill-Rom
Information provided by (Responsible Party):	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.

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	High Frequency Chest Wall Oscillation in Hospital Management of Asthmatic Children

Resource links provided by NLM:

MedlinePlus related topics: Asthma

U.S. FDA Resources

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 ]

Enrollment:	2
Study Start Date:	July 2008
Study Completion Date:	July 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 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. Other Name: Hill-Rom Vest(tm)
Sham Comparator: 2 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

No publications provided

Responsible Party:	Hill-Rom
ClinicalTrials.gov Identifier:	NCT00722020 History of Changes
Other Study ID Numbers:	CR-0078
Study First Received:	July 23, 2008
Last Updated:	November 14, 2011
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

Additional relevant MeSH terms:

Asthma
Status Asthmaticus
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity

Immune System Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012