Trial Outcomes & Findings for HFCWO in Hospitalized Asthmatic Children (NCT NCT00722020)
NCT ID: NCT00722020
Last Updated: 2017-08-07
Results Overview
Days in the hospital prior to patient being clinically ready to discharge
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
30 days
Results posted on
2017-08-07
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
24
|
|
Overall Study
COMPLETED
|
19
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HFCWO in Hospitalized Asthmatic Children
Baseline characteristics by cohort
| Measure |
HFCWO / VEST
n=19 Participants
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.
|
Standard Care With Sham Vest
n=24 Participants
Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.0 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
8.2 years
STANDARD_DEVIATION 2.0 • n=7 Participants
|
8.2 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: asthmatic children
Days in the hospital prior to patient being clinically ready to discharge
Outcome measures
| Measure |
HFCWO / VEST Group
n=19 Participants
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.
|
Standard Care
n=24 Participants
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.
|
|---|---|---|
|
The Primary Endpoint Will be Time to Readiness for Discharge.
|
1.74 days
Standard Deviation .7
|
1.75 days
Standard Deviation .6
|
SECONDARY outcome
Timeframe: 30 DaysSeconadary endpoint was Total Hospital length of stay
Outcome measures
| Measure |
HFCWO / VEST Group
n=19 Participants
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.
|
Standard Care
n=24 Participants
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.
|
|---|---|---|
|
Secondary Endpoint Total Hospital Length of Stay
|
2.5 days
Standard Deviation 0.8
|
2.5 days
Standard Deviation 0.7
|
Adverse Events
HFCWO / VEST
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care With Sham Vest
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place