HFCWO in Hospitalized Asthmatic Children

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Hill-Rom

ClinicalTrials.gov Identifier:

NCT00722020

First received: July 23, 2008

Last updated: March 20, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 23, 2008
Last Updated Date	March 20, 2012
Start Date ^ICMJE	July 2008
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 24, 2008)	The primary endpoint will be time to readiness for discharge. [ Time Frame: Hospital days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00722020 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 24, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	HFCWO in Hospitalized Asthmatic Children
Official Title ^ICMJE	High Frequency Chest Wall Oscillation in Hospital Management of Asthmatic Children
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Bronchial Asthma Asthma Status Asthmaticus
Intervention ^ICMJE	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) Device: Regular nebulized bronchodilator treatment. Sham Vest treatment.
Study Arm (s)	Active Comparator: 1 Patients will receive HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment. Intervention: Device: High Frequency Chest Wall Oscillation via Vest (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. Intervention: Device: Regular nebulized bronchodilator treatment.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	2
Completion Date	July 2010
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Months to 18 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00722020
Other Study ID Numbers ^ICMJE	CR-0078
Has Data Monitoring Committee	No
Responsible Party	Hill-Rom
Study Sponsor ^ICMJE	Hill-Rom
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hill-Rom
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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