Comparison of Nebulizers in ED in Pediatric Asthma Patients
Comparison of Nebulizers in ED in Pediatric Asthma Patients
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
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.
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