Bronchial Asthma, Asthma, Status Asthmaticus
Conditions
Keywords
Asthma, Bronchial Disease, Status Asthmaticus, High Frequency Chest Wall Oscillation, the Vest, HFCWO
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
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.
Interventions
DEVICEVEST
15 minutes of HFCWO via the Vest 2-3 times daily
Sponsors
Hill-Rom
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Months to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Endpoint Will be Time to Readiness for Discharge. | 30 days | Days in the hospital prior to patient being clinically ready to discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoint Total Hospital Length of Stay | 30 Days | Seconadary endpoint was Total Hospital length of stay |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| Standard Care With Sham Vest Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment. | 24 |
| Total | 43 |
Baseline characteristics
| Characteristic | HFCWO / VEST | Standard Care With Sham Vest | Total |
|---|---|---|---|
| Age, Continuous | 8.0 years STANDARD_DEVIATION 2.3 | 8.2 years STANDARD_DEVIATION 2 | 8.2 years STANDARD_DEVIATION 1.5 |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Male | 9 Participants | 14 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 24 |
| serious Total, serious adverse events | 0 / 19 | 0 / 24 |
Outcome results
Primary
The Primary Endpoint Will be Time to Readiness for Discharge.
Days in the hospital prior to patient being clinically ready to discharge
Time frame: 30 days
Population: asthmatic children
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HFCWO / VEST Group | The Primary Endpoint Will be Time to Readiness for Discharge. | 1.74 days | Standard Deviation 0.7 |
| Standard Care | The Primary Endpoint Will be Time to Readiness for Discharge. | 1.75 days | Standard Deviation 0.6 |
Secondary
Secondary Endpoint Total Hospital Length of Stay
Seconadary endpoint was Total Hospital length of stay
Time frame: 30 Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HFCWO / VEST Group | Secondary Endpoint Total Hospital Length of Stay | 2.5 days | Standard Deviation 0.8 |
| Standard Care | Secondary Endpoint Total Hospital Length of Stay | 2.5 days | Standard Deviation 0.7 |