Clinical trial NCT01951378: Comparison of Nebulizers in ED in Pediatric Asthma Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
Asthma exacerbation
Lead sponsor: Seton Healthcare Family
Sponsor class: OTHER
First posted: 2013-09-26
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 1 year
Secondary outcomes:
measure: to Evaluate Admission Rates.
timeFrame: 1 year
Other outcomes:
measure: Will Evaluate Hospital LOS. Safety Issue?: (FDAAA) No
timeFrame: 1 year
measure: Will Evaluate Need for Additional Therapies.
timeFrame: 1 year
measure: Will Evaluate Transfers to a Higher Level of Care.
timeFrame: 1 year
measure: Will Evaluate for Unscheduled Return Visits.
timeFrame: 1 year
Locations:
city: Austin
country: United States
facility: Dell Children's Medical Center of Central Texas
state: Texas
Study officials:
affiliation: Seton Healthcare Family
name: Matthew H. Wilkinson, MD
role: PRINCIPAL_INVESTIGATOR
References: