Heliox-Driven Racemic Epinephrine in Treatment of Bronchiolitis in Pediatric ED Patients

• Sponsor: University of Louisville (Other)
• Overall Status: Completed
• CT.gov ID: NCT00116584
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 2
• Duration (Months): 82
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis	Drug: heliox; Drug: oxygen	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Use of Heliox Driven Racemic Epinephrine Nebulization in the Treatment of Moderate to Severe Bronchiolitis in Pediatric Emergency Department Patients
• Study Start Date: Dec 1, 2004
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: heliox heliox-driven nebulizations for children with moderate to severe bronchiolitis	Drug: heliox; continuous heliox therapy
Other: oxygen oxygen-driven nebulizations for children with moderate to severe bronchiolitis	Drug: oxygen; continuous oxygen therapy

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Months to 12 Months
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kosair Children's Hospital	Louisville	Kentucky	United States	40202

Sponsors and Collaborators

• University of Louisville

Investigators

• Principal Investigator: In K Kim, MD, University of Louisville, Dept. of Pediatrics, Div. of Pediatric Emergency Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: In K. Kim, Professor, University of Louisville
• ClinicalTrials.gov Identifier: NCT00116584
• Other Study ID Numbers: GRNT040954; GRNT040954; G040954
• First Posted: Jun 30, 2005
• Last Update Posted: May 20, 2020
• Last Verified: May 1, 2020

• Keywords provided by In K. Kim, Professor, University of Louisville: heliox; bronchiolitis; racemic epinephrine
• Additional relevant MeSH terms: Bronchiolitis

Study Results

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.

Arm/Group Title	Heliox	Oxygen
Arm/Group Description	Patients were randomized to the helium-oxygen received nebulized racemic epinephrine via a face mask.	Patients were randomized to 100% oxygen group and received nebulized racemic epinephrine via a face mask.
Period Title: Overall Study
STARTED	36	36
COMPLETED	34	35
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Heliox	Oxygen	Total
Arm/Group Description	heliox-driven nebulizations for children with moderate to severe bronchiolitis	Oxygen nebulizations for children with moderate to severe bronchiolitis	Total of all reporting groups
Overall Participants	34	35	69
Age (Months) [Mean (Full Range) ]
Mean (Full Range) [Months]	5.09	6.11	5.6
Sex: Female, Male (Count of Participants)
Female	11 32.4%	11 31.4%	22 31.9%
Male	23 67.6%	24 68.6%	47 68.1%

Outcome Measures

1. Primary Outcome

Title	Change in Modified Wood's Clinical Asthma Score (M-WCAS) From Baseline to 240 Minutes
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Heliox	Oxygen
Arm/Group Description	heliox-driven nebulizations for children with moderate to severe bronchiolitis	Oxygen nebulizations for children with moderate to severe bronchiolitis
Measure Participants	34	35
Mean (Full Range) [units on a scale]	1.84	.031

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Heliox, Oxygen
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Fisher Exact
	Comments

2. Secondary Outcome

Title	Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Heliox	Oxygen
Arm/Group Description	heliox-driven nebulizations for children with moderate to severe bronchiolitis	Oxygen nebulizations for children with moderate to severe bronchiolitis
Measure Participants	34	35
Differenceof MWCBS at 0 mins	-0.33	0
Difference of MWCBS at 60 mins	0.54	0
Difference of MWCBS at 120 mins	0.77	0
Difference of MWCBS at 180 mins	0.94	0
Difference of MWCBS at 240 mins	1.20	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Heliox, Oxygen
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

Title	Change in Respiratory Distress Assessment Instrument (RDAI) Scores in Oxygen and Heliox Groups at Different Times
Description	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

Outcome Measure Data

Analysis Population Description

The Respiratory Distress Assessment Instrument (RDAI) has been used extensively. It is one of the most commonly used clinical scores for bronchiolitis,.

Arm/Group Title	Heliox	Oxygen
Arm/Group Description	heliox-driven nebulizations for children with moderate to severe bronchiolitis	Oxygen nebulizations for children with moderate to severe bronchiolitis
Measure Participants	34	35
Difference between RDAI at 0 min	-0.48	0
Difference of RDAI at 60 mins	1.80	0
Difference of RDAI at 120 mins	2.92	0
Difference of RDAI at 180 mins	3.00	0
Difference of RDAI at 240 mins	3.29	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Heliox, Oxygen
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Arm/Group Title	Heliox		Oxygen
Arm/Group Description	heliox-driven nebulizations for children with moderate to severe bronchiolitis		Oxygen nebulizations for children with moderate to severe bronchiolitis
All Cause Mortality
	Heliox		Oxygen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/35 (0%)
Serious Adverse Events
	Heliox		Oxygen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/35 (0%)
Other (Not Including Serious) Adverse Events
	Heliox		Oxygen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/35 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.