HFCWO in Hospitalized Asthmatic Children

Study Overview
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Brief Summary
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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
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A historically controlled pilot study was conducted in pediatric patients 18 months to 18 years of age hospitalized with a diagnosis of asthma or reactive airway disease and admitted to the pediatric intensive care unit. Upon receiving informed consent, patients were treated with HFCWO therapy via the VEST. The primary endpoint was time to readiness for discharge, lack of need for continued supportive care (e.g., intravenous fluid or oxygen), and bronchodilator treatments spaced at least four hours apart.

Official Title
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High Frequency Chest Wall Oscillation in Hospital Management of Asthmatic Children

Conditions
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Bronchial Asthma, Asthma, Status Asthmaticus

Intervention / Treatment
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* Device: VEST


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vest Arm<br>HFCWO treatments 2-3 times daily 15 minutes per treatment via the VEST | Device: VEST<br>* 15 minutes of HFCWO via the Vest 2-3 times daily<br>* Other names: Hill-Rom Vest(tm);|
| No Intervention: Control<br>Historical control for PICU asthma patients | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Endpoint Will be Time to Readiness for Discharge. | Days in the hospital prior to patient being clinically ready to discharge | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Endpoint Total Hospital Length of Stay | Seconadary endpoint was Total Hospital length of stay | 30 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Bronchial Disease, Status Asthmaticus, High Frequency Chest Wall Oscillation, the Vest, HFCWO