Comparison of Nebulizers in ED in Pediatric Asthma Patients
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 3 - 17 |
| Updated: | 4/21/2016 |
| Start Date: | September 2013 |
| End Date: | July 2016 |
Comparison of a Breath Enhanced High Density Jet Nebulizer With a Standard Jet Nebulizer for the Treatment of Children With a Moderate to Severe Asthma Exacerbation in the Emergency Department
The primary objective will be, in an open-label randomized trial, a comparison of emergency
department (ED) length of stay (LOS) between children experiencing acute asthma treated with
two different nebulizers. Secondary outcomes will include admission rates, hospital LOS,
need for additional therapies, transfers to a higher level of care, side-effects, and
unscheduled return visits
department (ED) length of stay (LOS) between children experiencing acute asthma treated with
two different nebulizers. Secondary outcomes will include admission rates, hospital LOS,
need for additional therapies, transfers to a higher level of care, side-effects, and
unscheduled return visits
To our knowledge, no study has compared a breath-enhanced nebulizer to a standard jet
nebulizer for the treatment of acute asthma in children. The goal of this study is to
determine whether a rapid albuterol delivery pathway with a breath-enhanced nebulizer can
reduce ED LOS, while maintaining admission rates, repeat visits, adjunctive therapies, and
side-effects, when compared to a traditional asthma pathway with a standard jet nebulizer.
The Salter® Nebutech® HDN® was chosen because its breath-enhanced design and bolus delivery
system may deliver greater amounts of albuterol to the small airways, in a shorter period of
time, when compared with standard jet nebulizers and other nebulizers in its class.
The study site will be a large, urban pediatric emergency department (ED) with approximately
80,000 visits per year. The study protocol will be submitted to the hospital's Institutional
Review Board (IRB) for approval. Children will be eligible for enrolment if they are between
3 and 18 years of age and present to the ED with an acute asthma exacerbation of at least
moderate severity. The lower age cutoff was chosen because asthma diagnosis and beta agonist
response can be unreliable in younger children. The upper age cutoff was chosen to include
only pediatric patients, as this is a pediatric asthma study. Children must have a history
of physician-diagnosed asthma as reported by the parent or guardian. Children will be
enrolled when a research team member is available to obtain informed consent (convenience
sample). Children will be excluded from enrollment if the initial pediatric asthma score
(PAS) is < 3, immediate resuscitation is required, they have a history of chronic lung
disease or congenital heart disease, they have any neuromuscular disease, intrathoracic
foreign body is suspected, they are or may be pregnant, they are currently breast feeding,
they have received oral or parenteral steroids within the last week (inhaled steroids are
allowed), or they have an allergy or other contraindication to one of the study medications.
Potential subjects will be identified in triage and screened for enrolment if study
personnel are available. If consented, the patient will be randomized to one of the two
treatment arms. If there will be greater than a 15 minute delay in treatment due to the
consent process, unit dose (2.5 mg) albuterol treatments will be given with a standard
nebulizer up to 3 times as needed. That patient may still be enrolled provided he/she still
meets inclusion/exclusion criteria.
nebulizer for the treatment of acute asthma in children. The goal of this study is to
determine whether a rapid albuterol delivery pathway with a breath-enhanced nebulizer can
reduce ED LOS, while maintaining admission rates, repeat visits, adjunctive therapies, and
side-effects, when compared to a traditional asthma pathway with a standard jet nebulizer.
The Salter® Nebutech® HDN® was chosen because its breath-enhanced design and bolus delivery
system may deliver greater amounts of albuterol to the small airways, in a shorter period of
time, when compared with standard jet nebulizers and other nebulizers in its class.
The study site will be a large, urban pediatric emergency department (ED) with approximately
80,000 visits per year. The study protocol will be submitted to the hospital's Institutional
Review Board (IRB) for approval. Children will be eligible for enrolment if they are between
3 and 18 years of age and present to the ED with an acute asthma exacerbation of at least
moderate severity. The lower age cutoff was chosen because asthma diagnosis and beta agonist
response can be unreliable in younger children. The upper age cutoff was chosen to include
only pediatric patients, as this is a pediatric asthma study. Children must have a history
of physician-diagnosed asthma as reported by the parent or guardian. Children will be
enrolled when a research team member is available to obtain informed consent (convenience
sample). Children will be excluded from enrollment if the initial pediatric asthma score
(PAS) is < 3, immediate resuscitation is required, they have a history of chronic lung
disease or congenital heart disease, they have any neuromuscular disease, intrathoracic
foreign body is suspected, they are or may be pregnant, they are currently breast feeding,
they have received oral or parenteral steroids within the last week (inhaled steroids are
allowed), or they have an allergy or other contraindication to one of the study medications.
Potential subjects will be identified in triage and screened for enrolment if study
personnel are available. If consented, the patient will be randomized to one of the two
treatment arms. If there will be greater than a 15 minute delay in treatment due to the
consent process, unit dose (2.5 mg) albuterol treatments will be given with a standard
nebulizer up to 3 times as needed. That patient may still be enrolled provided he/she still
meets inclusion/exclusion criteria.
Inclusion Criteria:
- Age ≥ 3 years and < 18 years
- History of physician-diagnosed asthma
- Presenting to ED with acute asthma exacerbation according to attending physician
Exclusion Criteria:
- PAS score < 3
- Immediate resuscitation required
- Chronic lung disease (other than asthma)
- Congenital heart disease 5. Neuromuscular disease 6. Suspected intrathoracic foreign
body 7. Is or may be pregnant 8. Currently breast feeding 9. Oral or parenteral
steroids within the last 7 days 10. Allergy or other contraindication to any of the
study medications
We found this trial at
1
site
4900 Mueller Boulevard
Austin, Texas 78723
Austin, Texas 78723
(512) 324-0000
Dell Children's Medical Center of Central Texas Welcome to Dell Children
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