Trial · NCT00116584
Heliox-Driven Racemic Epinephrine in Treatment of Bronchiolitis in Pediatric ED Patients
NCT00116584, Phase 3, Completed, University of Louisville; results first posted 2020-05-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Heliox-Driven Racemic Epinephrine in Treatment of Bronchiolitis in Pediatric ED Patients. Trials, record NCT00116584. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00116584
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Heliox-Driven Racemic Epinephrine in Treatment of Bronchiolitis in Pediatric ED Patients
- NCT number
- NCT00116584
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 72 participants, actual
- Lead sponsor
- University of Louisville
- Conditions
- Bronchiolitis
- Interventions
- heliox, oxygen
- First posted
- 2005-06-30
- Last updated
- 2020-05-20
- Results first posted
- 2020-05-20
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Modified Wood's Clinical Asthma Score (M-WCAS) From Baseline to 240 Minutes | 240 Minutes | 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. |
| Secondary | Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times | 0, 60, 120, 180 and 240 min | The 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. |
| Secondary | Change in Respiratory Distress Assessment Instrument (RDAI) Scores in Oxygen and Heliox Groups at Different Times | 0, 60, 120, 180 and 240 mins | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Modified Wood's Clinical Asthma Score (M-WCAS) From Baseline to 240 Minutes | 240 Minutes | units on a scale | MEAN | |
| SECONDARY | Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times | 0, 60, 120, 180 and 240 min | units on a scale | MEAN | |
| SECONDARY | Change in Respiratory Distress Assessment Instrument (RDAI) Scores in Oxygen and Heliox Groups at Different Times | 0, 60, 120, 180 and 240 mins | The Respiratory Distress Assessment Instrument (RDAI) has been used extensively. It is one of the most commonly used clinical scores for bronchiolitis,. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Modified Wood's Clinical Asthma Score (M-WCAS) From Baseline to 240 Minutes | Heliox | 1.84 | Full Range 0 to 10 | units on a scale | |
| Change in Modified Wood's Clinical Asthma Score (M-WCAS) From Baseline to 240 Minutes | Oxygen | .031 | Full Range 0 to 10 | units on a scale | |
| Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times | Heliox | Differenceof MWCBS at 0 mins | -0.33 | 95% Confidence Interval -0.71 to 0.59 | units on a scale |
| Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times | Oxygen | Differenceof MWCBS at 0 mins | 0 | 95% Confidence Interval 0 to 0 | units on a scale |
| Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times | Heliox | Difference of MWCBS at 60 mins | 0.54 | 95% Confidence Interval 0.18 to 0.91 | units on a scale |
| Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times | Oxygen | Difference of MWCBS at 60 mins | 0 | 95% Confidence Interval 0 to 0 | units on a scale |
| Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times | Heliox | Difference of MWCBS at 120 mins | 0.77 | 95% Confidence Interval 0.45 to 1.09 | units on a scale |
| Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times | Oxygen | Difference of MWCBS at 120 mins | 0 | 95% Confidence Interval 0 to 0 | units on a scale |
| Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times | Heliox | Difference of MWCBS at 180 mins | 0.94 | 95% Confidence Interval 0.63 to 1.26 | units on a scale |
| Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times | Oxygen | Difference of MWCBS at 180 mins | 0 | 95% Confidence Interval 0 to 0 | units on a scale |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Heliox | 36 | |
| Overall Study | STARTED | Oxygen | 36 | |
| Overall Study | COMPLETED | Heliox | 34 | |
| Overall Study | COMPLETED | Oxygen | 35 | |
| Overall Study | NOT COMPLETED | Heliox | 2 | |
| Overall Study | NOT COMPLETED | Oxygen | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Heliox | 0 | 34 |
| Total, all-cause mortality | Oxygen | 0 | 35 |
| Total, other adverse events | Heliox | 0 | 34 |
| Total, other adverse events | Oxygen | 0 | 35 |
| Total, serious adverse events | Heliox | 0 | 34 |
| Total, serious adverse events | Oxygen | 0 | 35 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22147778 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Heliox vs Oxygen: deaths from any cause | Trial comparisons |
| Heliox vs Oxygen: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00116584
GET https://conductscience.org/api/trials/v1/NCT00116584/results?page=2