Bronchiolitis
Conditions
Keywords
heliox, bronchiolitis, racemic epinephrine
Brief summary
The purpose of this study is to assess whether children with moderate to severe bronchiolitis treated with standard racemic epinephrine therapy via 70:30 helium-oxygen (heliox) driven nebulization will have improvements in measurements of airway more rapidly than those treated with conventional air-oxygen driven nebulization.
Interventions
DRUGheliox
continuous heliox therapy
DRUGoxygen
continuous oxygen therapy
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Months to 12 Months
Healthy volunteers
Yes
Inclusion criteria
* Any child 2-12 months old seen in the emergency department. * A clinical bronchiolitis score \> 3 by modified Wood's Clinical Bronchiolitis Score (M-WCBS). * Diagnostic criteria of bronchiolitis includes tachypnea, cough, prolonged expiratory phase, wheezing, rales, chest retractions, and hyperinflation of lungs on chest radiograph. After consenting a patient to the study, respiratory syncytial virus (RSV) infection will be tested by rapid enzyme-linked immunoabsorbent assay of nasal secretions.
Exclusion criteria
* No child will be excluded based on race or gender * Patients under the age of 2 months or greater than 12 months * Patients with cyanotic heart disease * Patients with lobar pneumonia, defined by results of chest radiographs. * The presence of interstitial disease or diffuse patchy marking consistent with atelectasis on chest radiographs will not exclude patients. * Patients with croup. * Patients with foreign body aspiration. * Patients with history of cystic fibrosis, bronchopulmonary dysplasia or other chronic lung disease. * Patients with liver or renal disease. * Patients with sickle cell anemia. * Patients requiring mechanical ventilation. * Patients who develop supraventricular tachycardia secondary to racemic epinephrine administration. * Patients with tracheomalacia or bronchomalacia. * Patients who had received bronchodilators within 2 hours of initiation of the study. * Patients who had received systemic corticosteroids within 72 hours of enrollment * Patients who suffered from persistent airway hyperreactivity in the 3 months before the study. * Patients who do not tolerate the nasal cannulae for 45 out of 60 minutes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
This study was conducted from October 1, 2004 through May 31, 2008 in the emergency department of an urban, tertiary care children's hospital.
Participants by arm
| Arm | Count |
|---|---|
| Heliox heliox-driven nebulizations for children with moderate to severe bronchiolitis | 34 |
| Oxygen Oxygen nebulizations for children with moderate to severe bronchiolitis | 35 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Heliox | Oxygen | Total |
|---|---|---|---|
| Age, Continuous | 5.09 Months | 6.11 Months | 5.6 Months |
| Sex: Female, Male Female | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Male | 23 Participants | 24 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 35 |
| other Total, other adverse events | 0 / 34 | 0 / 35 |
| serious Total, serious adverse events | 0 / 34 | 0 / 35 |
Outcome results
Primary
Change in Modified Wood's Clinical Asthma Score (M-WCAS) From Baseline to 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.
Time frame: 240 Minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Heliox | Change in Modified Wood's Clinical Asthma Score (M-WCAS) From Baseline to 240 Minutes | 1.84 units on a scale |
| Oxygen | Change in Modified Wood's Clinical Asthma Score (M-WCAS) From Baseline to 240 Minutes | .031 units on a scale |
p-value: <0.05Fisher Exact
Secondary
Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times
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.
Time frame: 0, 60, 120, 180 and 240 min
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Heliox | 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 |
| Heliox | 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 |
| Heliox | 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 |
| Heliox | 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 |
| Heliox | 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 |
| Oxygen | Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times | Difference of MWCBS at 240 mins | 0 units on a scale |
| Oxygen | Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times | Differenceof MWCBS at 0 mins | 0 units on a scale |
| Oxygen | Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times | Difference of MWCBS at 60 mins | 0 units on a scale |
| Oxygen | Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times | Difference of MWCBS at 120 mins | 0 units on a scale |
| Oxygen | Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times | Difference of MWCBS at 180 mins | 0 units on a scale |
p-value: <0.05Wilcoxon (Mann-Whitney)
Secondary
Change in Respiratory Distress Assessment Instrument (RDAI) Scores in Oxygen and Heliox Groups at Different Times
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.
Time frame: 0, 60, 120, 180 and 240 mins
Population: The Respiratory Distress Assessment Instrument (RDAI) has been used extensively. It is one of the most commonly used clinical scores for bronchiolitis,.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Heliox | 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 |
| Heliox | 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 |
| Heliox | 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 |
| Heliox | 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 |
| Heliox | 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 |
| Oxygen | Change in Respiratory Distress Assessment Instrument (RDAI) Scores in Oxygen and Heliox Groups at Different Times | Difference of RDAI at 240 mins | 0 units on a scale |
| Oxygen | Change in Respiratory Distress Assessment Instrument (RDAI) Scores in Oxygen and Heliox Groups at Different Times | Difference between RDAI at 0 min | 0 units on a scale |
| Oxygen | Change in Respiratory Distress Assessment Instrument (RDAI) Scores in Oxygen and Heliox Groups at Different Times | Difference of RDAI at 60 mins | 0 units on a scale |
| Oxygen | Change in Respiratory Distress Assessment Instrument (RDAI) Scores in Oxygen and Heliox Groups at Different Times | Difference of RDAI at 120 mins | 0 units on a scale |
| Oxygen | Change in Respiratory Distress Assessment Instrument (RDAI) Scores in Oxygen and Heliox Groups at Different Times | Difference of RDAI at 180 mins | 0 units on a scale |
p-value: <0.05Wilcoxon (Mann-Whitney)