Trial Outcomes & Findings for Use of High Frequency Chest Compression in Pediatric Status Asthmaticus (NCT NCT00552448)
NCT ID: NCT00552448
Last Updated: 2016-09-14
Results Overview
Length of stay (hours) in Pediatric ICU.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Number of hours from admission to discharge from PICU
Results posted on
2016-09-14
Participant Flow
Participant milestones
| Measure |
Pediatric Status Asthmatics Patients on HFCC Device
Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received
High Frequency Chest Compression VEST: every 6 hours for 20 minutes
|
Pediatric Status Asthmaticus Patients Not Using HFCC
This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
16
|
|
Overall Study
COMPLETED
|
19
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of High Frequency Chest Compression in Pediatric Status Asthmaticus
Baseline characteristics by cohort
| Measure |
Pediatric Status Asthmatics Patients on HFCC Device
n=20 Participants
Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received
High Frequency Chest Compression VEST: every 6 hours for 20 minutes
|
Pediatric Status Asthmaticus Patients Not Using HFCC
n=16 Participants
This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.95 years
STANDARD_DEVIATION 3.53 • n=5 Participants
|
6.69 years
STANDARD_DEVIATION 3.93 • n=7 Participants
|
6.28 years
STANDARD_DEVIATION 3.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
9 participants
n=5 Participants
|
2 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Two or more Ethnicity/Races
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity/Race Unknown
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
16 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Prior Hospitalizations
Yes
|
11 participants
n=5 Participants
|
8 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Prior Hospitalizations
None
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Prior Hospitalizations
Unknown
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Home asthma medication
None
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Home asthma medication
Bronchodilator alone
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Home asthma medication
Inhaled steroid
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Home asthma medication
Inhaled steroid-long acting bronchodilator
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Home asthma medication
leukotriene receptor antagonist
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Home asthma medication
Antihistamine
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Home asthma medication
Systemic steroid
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Modified Pulmonary Index Score (Initial)
|
5.76 units on a scale
STANDARD_DEVIATION 2.91 • n=5 Participants
|
6.42 units on a scale
STANDARD_DEVIATION 2.91 • n=7 Participants
|
6.03 units on a scale
STANDARD_DEVIATION 2.87 • n=5 Participants
|
PRIMARY outcome
Timeframe: Number of hours from admission to discharge from PICULength of stay (hours) in Pediatric ICU.
Outcome measures
| Measure |
Pediatric Status Asthmatics Patients on HFCC Device
n=19 Participants
Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received
High Frequency Chest Compression VEST: every 6 hours for 20 minutes
|
Pediatric Status Asthmaticus Patients Not Using HFCC
n=16 Participants
This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
|
|---|---|---|
|
Hours Spent in Pediatric ICU
|
23.71 Hours
Standard Deviation 8.33
|
23.76 Hours
Standard Deviation 12.24
|
SECONDARY outcome
Timeframe: DaysPopulation: Data not collected
This is limited due to non collection by collaborating centers.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Discharge from PICUPopulation: Participants with available data
Modified Pulmonary Index Score (MPIS): a validated asthma severity score in pediatric population (Carroll CL et al. A modified pulmonary index score with predictive value for pediatric asthma exacerbations, Ann Allergy Asthma Immunol 2005) Consists of: 1) oxygen saturation on room air 2) accessory muscle use 3) inspiratory to expiratory ratio 4) degree of wheezing 5) heart rate 6) respiratory rate Scored observations 0, 1, 2 or 3. Total score range 0 - 18. Mild exacerbation total less than 6, moderate exacerbation 6 - 10, severe exacerbation higher than 10
Outcome measures
| Measure |
Pediatric Status Asthmatics Patients on HFCC Device
n=18 Participants
Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received
High Frequency Chest Compression VEST: every 6 hours for 20 minutes
|
Pediatric Status Asthmaticus Patients Not Using HFCC
n=13 Participants
This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
|
|---|---|---|
|
Pediatric Asthma Severity Score (Modified Pulmonary Index Score)
|
1.88 units on a scale
Interval 0.0 to 5.0
|
1.9 units on a scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: During PICU admissionOutcome measures
| Measure |
Pediatric Status Asthmatics Patients on HFCC Device
n=20 Participants
Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received
High Frequency Chest Compression VEST: every 6 hours for 20 minutes
|
Pediatric Status Asthmaticus Patients Not Using HFCC
n=16 Participants
This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
|
|---|---|---|
|
Number of Participants With Chest Discomfort
|
3 participants
|
0 participants
|
Adverse Events
Pediatric Status Asthmatics Patients on HFCC Device
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Pediatric Status Asthmaticus Patients Not Using HFCC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pediatric Status Asthmatics Patients on HFCC Device
n=20 participants at risk
Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received
High Frequency Chest Compression VEST: every 6 hours for 20 minutes
|
Pediatric Status Asthmaticus Patients Not Using HFCC
n=16 participants at risk
This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chest discomfort (anticipated)
|
15.0%
3/20 • Number of events 3
|
0.00%
0/16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place