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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vest Arm | Experimental | HFCWO treatments 2-3 times daily 15 minutes per treatment via the VEST |
|
| Control | No Intervention | Historical control for PICU asthma patients |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VEST | Device | 15 minutes of HFCWO via the Vest 2-3 times daily |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoint Total Hospital Length of Stay | Seconadary endpoint was Total Hospital length of stay | 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon Roberts, MD | Winthrop University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winthrop University Hospital, Winthrop Pediatric Associates | Long Island City | New York | 11501 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | HFCWO / VEST Group | Patients will receive HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment. 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. |
| FG001 | Standard Care | Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment. Regular nebulized bronchodilator treatment.: Sham Vest treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Pediatric patients admitted with diagnosis of Asthma
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| ID | Title | Description |
|---|---|---|
| BG000 | HFCWO / VEST | Pediatric patients with primary diagnosis of Asthma received HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment. Patients receive 15 minutes of HFCWO via the Vest. |
| BG001 | Standard Care With Sham Vest |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Endpoint Will be Time to Readiness for Discharge. | Days in the hospital prior to patient being clinically ready to discharge | asthmatic children | Posted | Mean | Standard Deviation | days | 30 days |
|
ICU admission and hospital admission time
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HFCWO / VEST | Pediatric patients with primary diagnosis of Asthma received HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment. Patients receive 15 minutes of HFCWO via the Vest. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jon Roberts, MD | Winthrop University | 516-663-4600 | jroberts@winthrop.org |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D013224 | Status Asthmaticus |
| D001982 | Bronchial Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
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| Winthrop University Hospital |
| Long Island City |
| New York |
| 11501 |
| United States |
Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Secondary Endpoint Total Hospital Length of Stay | Seconadary endpoint was Total Hospital length of stay | Posted | Mean | Standard Deviation | days | 30 Days |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Standard Care With Sham Vest | Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment. | 0 | 24 | 0 | 24 |
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| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |