Trial Outcomes & Findings for Heliox-Driven Racemic Epinephrine in Treatment of Bronchiolitis in Pediatric ED Patients (NCT NCT00116584)
NCT ID: NCT00116584
Last Updated: 2020-05-20
Results Overview
The Modified Wood's clinical Asthma Score is a score to measure severity of Asthma in children. There are 5 variables measured: oxygen saturation, inspiratory breath sounds, expiratory wheezing, accessory muscle involvement and cerebral function. Each variable is given a score of 0, 0.5, 1 or 2 with 2 being the most severe. The scores are combined from each variable to give a total. Total score ranges from 0 to 10, with a score of 10 (higher the score) indicating a worse outcome. We are reporting the degree of improvement in M-WCAS after assigned treatment.
COMPLETED
PHASE3
72 participants
240 Minutes
2020-05-20
Participant Flow
This study was conducted from October 1, 2004 through May 31, 2008 in the emergency department of an urban, tertiary care children's hospital.
Participant milestones
| Measure |
Heliox
Patients were randomized to the helium-oxygen received nebulized racemic epinephrine via a face mask.
|
Oxygen
Patients were randomized to 100% oxygen group and received nebulized racemic epinephrine via a face mask.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
|
Overall Study
COMPLETED
|
34
|
35
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Heliox
Patients were randomized to the helium-oxygen received nebulized racemic epinephrine via a face mask.
|
Oxygen
Patients were randomized to 100% oxygen group and received nebulized racemic epinephrine via a face mask.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Heliox-Driven Racemic Epinephrine in Treatment of Bronchiolitis in Pediatric ED Patients
Baseline characteristics by cohort
| Measure |
Heliox
n=34 Participants
heliox-driven nebulizations for children with moderate to severe bronchiolitis
|
Oxygen
n=35 Participants
Oxygen nebulizations for children with moderate to severe bronchiolitis
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.09 Months
n=5 Participants
|
6.11 Months
n=7 Participants
|
5.6 Months
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 240 MinutesThe Modified Wood's clinical Asthma Score is a score to measure severity of Asthma in children. There are 5 variables measured: oxygen saturation, inspiratory breath sounds, expiratory wheezing, accessory muscle involvement and cerebral function. Each variable is given a score of 0, 0.5, 1 or 2 with 2 being the most severe. The scores are combined from each variable to give a total. Total score ranges from 0 to 10, with a score of 10 (higher the score) indicating a worse outcome. We are reporting the degree of improvement in M-WCAS after assigned treatment.
Outcome measures
| Measure |
Heliox
n=34 Participants
heliox-driven nebulizations for children with moderate to severe bronchiolitis
|
Oxygen
n=35 Participants
Oxygen nebulizations for children with moderate to severe bronchiolitis
|
|---|---|---|
|
Change in Modified Wood's Clinical Asthma Score (M-WCAS) From Baseline to 240 Minutes
|
1.84 units on a scale
Interval 0.0 to 10.0
|
.031 units on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: 0, 60, 120, 180 and 240 minThe Modified Wood's Clinical Bronchiolitis Score is based on a rating of saturated oxygen, inspiratory breath sounds, expiratory wheezing, accessory muscle use, cerebral function and wheezing. Each variable is rated 0, 0.5, 1, or 2. The total range of score is 0 to 2, with 2 (higher the score) indicating a worse outcome. For this outcome, a negative difference between groups represents an improvement.
Outcome measures
| Measure |
Heliox
n=34 Participants
heliox-driven nebulizations for children with moderate to severe bronchiolitis
|
Oxygen
n=35 Participants
Oxygen nebulizations for children with moderate to severe bronchiolitis
|
|---|---|---|
|
Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times
Difference of MWCBS at 120 mins
|
0.77 units on a scale
Interval 0.45 to 1.09
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times
Differenceof MWCBS at 0 mins
|
-0.33 units on a scale
Interval -0.71 to 0.59
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times
Difference of MWCBS at 60 mins
|
0.54 units on a scale
Interval 0.18 to 0.91
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times
Difference of MWCBS at 180 mins
|
0.94 units on a scale
Interval 0.63 to 1.26
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times
Difference of MWCBS at 240 mins
|
1.20 units on a scale
Interval 0.87 to 1.54
|
0 units on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 0, 60, 120, 180 and 240 minsPopulation: The Respiratory Distress Assessment Instrument (RDAI) has been used extensively. It is one of the most commonly used clinical scores for bronchiolitis,.
The RDAI is an assessment instrument for respiratory distress. Patients are assigned a point value based on Wheezing (on expiration, inspiration and location) and Retractions (local of supraclavicular, intercostal and subcostal). Each subcategory is assigned a value of 0-4. The subscores are summed to give a total score for each variable (wheezing and retractions). The total score range for wheezing is 0 to 8, with 8 (higher the score) indicating a worse outcome. The total score range for retractions is 0 to 9, with 9 (higher the score) indicating a worse outcome. We are reporting the difference in score between the groups at various times, not a change from an earlier time. A positive value represents an improvement in the Heliox vs the Oxygen groups.
Outcome measures
| Measure |
Heliox
n=34 Participants
heliox-driven nebulizations for children with moderate to severe bronchiolitis
|
Oxygen
n=35 Participants
Oxygen nebulizations for children with moderate to severe bronchiolitis
|
|---|---|---|
|
Change in Respiratory Distress Assessment Instrument (RDAI) Scores in Oxygen and Heliox Groups at Different Times
Difference of RDAI at 240 mins
|
3.29 units on a scale
Interval 2.35 to 4.23
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Change in Respiratory Distress Assessment Instrument (RDAI) Scores in Oxygen and Heliox Groups at Different Times
Difference between RDAI at 0 min
|
-0.48 units on a scale
Interval -1.55 to 0.59
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Change in Respiratory Distress Assessment Instrument (RDAI) Scores in Oxygen and Heliox Groups at Different Times
Difference of RDAI at 60 mins
|
1.80 units on a scale
Interval 0.55 to 3.07
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Change in Respiratory Distress Assessment Instrument (RDAI) Scores in Oxygen and Heliox Groups at Different Times
Difference of RDAI at 120 mins
|
2.92 units on a scale
Interval 1.77 to 4.07
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Change in Respiratory Distress Assessment Instrument (RDAI) Scores in Oxygen and Heliox Groups at Different Times
Difference of RDAI at 180 mins
|
3.00 units on a scale
Interval 1.99 to 4.01
|
0 units on a scale
Interval 0.0 to 0.0
|
Adverse Events
Heliox
Oxygen
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