Trial Outcomes & Findings for Treating Respiratory Emergencies in Children Study (NCT NCT06074185)
NCT ID: NCT06074185
Last Updated: 2026-04-24
Results Overview
Whether or not the patient was admitted to the hospital after the index EMS encounter
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
Within 24 hours of the index EMS encounter
Results posted on
2026-04-24
Participant Flow
The study screened 302 patients and enrolled 44, with one participant later found ineligible for having respiratory distress not caused by bronchospasm/wheeze, leading to 43 eligible patients with data available for analysis. The post-intervention phase accounted for 155 (51.3%) screened patients and 32 (72.7%) enrolled patients.
Participant milestones
| Measure |
Usual Care
Enrollment under usual care
|
Intervention Treatment Bundle
Enrollment with the intervention treatment bundle
|
|---|---|---|
|
Pre-intervention (6 months)
STARTED
|
12
|
0
|
|
Pre-intervention (6 months)
COMPLETED
|
11
|
0
|
|
Pre-intervention (6 months)
NOT COMPLETED
|
1
|
0
|
|
Post-intervention (7 months)
STARTED
|
0
|
32
|
|
Post-intervention (7 months)
COMPLETED
|
0
|
32
|
|
Post-intervention (7 months)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Usual Care
Enrollment under usual care
|
Intervention Treatment Bundle
Enrollment with the intervention treatment bundle
|
|---|---|---|
|
Pre-intervention (6 months)
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Treating Respiratory Emergencies in Children Study
Baseline characteristics by cohort
| Measure |
Pre-intervention
n=11 Participants
Enrolled under usual care before the intervention was introduced.
|
Post-intervention
n=32 Participants
Enrolled after the study intervention and checklist were introduced.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.5 Years
n=2 Participants
|
4.5 Years
n=1 Participants
|
5 Years
n=3 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=2 Participants
|
11 Participants
n=1 Participants
|
13 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=2 Participants
|
21 Participants
n=1 Participants
|
30 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=2 Participants
|
17 Participants
n=1 Participants
|
25 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=2 Participants
|
7 Participants
n=1 Participants
|
9 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
2 Participants
n=1 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=2 Participants
|
5 Participants
n=1 Participants
|
6 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=2 Participants
|
3 Participants
n=1 Participants
|
4 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=2 Participants
|
27 Participants
n=1 Participants
|
37 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
2 Participants
n=1 Participants
|
2 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Within 24 hours of the index EMS encounterWhether or not the patient was admitted to the hospital after the index EMS encounter
Outcome measures
| Measure |
Pre-intervention
n=6 Participants
Enrolled under usual care before the intervention was introduced.
|
Post-intervention
n=19 Participants
Enrolled after the study intervention and checklist were introduced.
|
|---|---|---|
|
Proportion of Patients Admitted to the Hospital in Each Group
|
6 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 6-8 days after the index EMS encounterQuality of life score for asthma. Range 0-100. A higher score equates to poorer quality of life.
Outcome measures
| Measure |
Pre-intervention
n=1 Participants
Enrolled under usual care before the intervention was introduced.
|
Post-intervention
n=2 Participants
Enrolled after the study intervention and checklist were introduced.
|
|---|---|---|
|
NIH Patient-Reported Outcomes Measurement Information Systems (PROMIS) Asthma Impact Scale
|
32 Score
Interval 32.0 to 32.0
|
22.5 Score
Interval 15.0 to 30.0
|
Adverse Events
Continue Current Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment Bundle and Checklist
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
Dr. Matt Hansen, Professor of Emergency Medicine
Oregon Health & Science University
Phone: 503-418-2291
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place