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

May 8, 2020 updated by: In K. Kim, University of Louisville

The Use of Heliox Driven Racemic Epinephrine Nebulization in the Treatment of Moderate to Severe Bronchiolitis in Pediatric Emergency Department Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Kosair Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Modified Wood's Clinical Asthma Score (M-WCAS) From Baseline to 240 Minutes
Time Frame: 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.
240 Minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times
Time Frame: 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.
0, 60, 120, 180 and 240 min
Change in Respiratory Distress Assessment Instrument (RDAI) Scores in Oxygen and Heliox Groups at Different Times
Time Frame: 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.
0, 60, 120, 180 and 240 mins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

June 29, 2005

First Submitted That Met QC Criteria

June 29, 2005

First Posted (Estimate)

June 30, 2005

Study Record Updates

Last Update Posted (Actual)

May 20, 2020

Last Update Submitted That Met QC Criteria

May 8, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRNT040954
  • G040954 (Other Grant/Funding Number: Praxair Healthcare)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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