Randomized Controlled Trial of a Breath-Actuated Nebulizer in Pediatric Asthma Patients in the Emergency Department

Abstract

BACKGROUND: Bronchodilator treatment for asthma can be provided with various aerosolgenerating devices and methods. There have been no randomized trials of a breath-actuated nebulizer versus continuous 1-hour nebulization and/or small-volume constant-output nebulizer in pediatric asthma patients. METHODS: We conducted a randomized study of one-time albuterol treatment with the AeroEclipse breath-actuated nebulizer versus standard therapy (single treatment via small-volume nebulizer or 1-hour of continuous nebulized albuterol) in pediatric asthma patients in the emergency department. Eligible patients were those admitted to the emergency department, 0 months to 18 years of age, who presented with asthma or wheezing. We assessed all the patients with our clinical asthma scoring system and peak-flow measurement if possible. We stratified the patients by clinical asthma score and weight, and then randomized them to receive their initial albuterol treatment in the emergency department via either AeroEclipse or standard therapy. We recorded time in the emergency department, change in clinical asthma score, need for additional bronchodilator treatments, need for admission, patient response, ability to actuate the AeroEclipse, and adverse effects. RESULTS: We enrolled 149 patients between October 14, 2004 and November 11, 2005, and we randomized 84 patients to AeroEclipse and 65 to standard therapy. The cohort's average age was 5.5 years. There were no significant differences in demographics. The initial mean clinical asthma scores were 5.1 ؎ 2.4 in the AeroEclipse group, and 5.1 ؎ 2.1 in the standard-therapy group. Time in the emergency department was not different (AeroEclipse 102 min, standard therapy 125 min, P ‫؍‬ .10), but the AeroEclipse group had a significantly greater improvement in clinical asthma score (1.9 ؎ 1.2 vs 1.2 ؎ 1.4, P ‫؍‬ .001) and respiratory rate (P ‫؍‬ .002), and significantly lower admission rate (38% vs 57%, P ‫؍‬ .03). There was no difference in adverse effects. CONCLUSIONS: Although AeroEclipse did not reduce the time in the ED, it significantly improved clinical asthma score, decreased admissions, and decreased respiratory rate.

Effective Bronchodilator Resuscitation of Children in the Emergency Room: Device or Interface?

“…This trend continues in the study by Sabato et al, who report that the admission rate with breath-actuated nebulizer and SVN were both 40%. 11 The mean clinical asthma score was lower in the SVN group (3.0) than in the AeroEclipse group (5.1). The results suggest that in patients with less severe asthma the SVN was as effective as AeroEclipse, but the comparison is complicated by the relatively small number of patients who received SVN (10 patients) versus AeroEclipse (86 patients).…”

“…25,26 Sabato et al address a very important research question: comparing breath-actuated nebulizer to LVN and SVN. 11 If breath-actuated nebulizer and LVN have similar particle-size distributions and respirable dose, then any differences in clinical response are more about the interface than about the aerosol generator. The observation that AeroEclipse with mask was better tolerated by children with severe asthma may provide an important insight into the observed difference in hospital admission.…”

“…11 This aspect of aerosol therapy has not been well studied and merits further investigation. Loose-fitting mask and blow-by dramatically reduce aerosol deposition.…”

“…In this issue of RESPIRATORY CARE, Sabato et al present findings from their randomized study of the efficacy of albuterol administered via the AeroEclipse breath-actuated nebulizer versus their institution's standard therapy (either SVN or LVN) in the treatment of pediatric patients presenting with asthma to the emergency department. 11 They are the first to report significant differences in admission rate and symptom-score improvement between the 2 treatment groups. Sabato and colleagues made a multidimensional assessment, including clinical asthma score, heart rate, respiratory rate, peak expiratory flow, patient tolerance of the treatment, nausea, tremor, vomiting, and hyperactivity.…”

The Impact of Standardizing Assessment and Treatment of Acute Asthma Exacerbations on Emergency Department Efficiency

“…Based upon NIH guidelines we instituted a multidisciplinary asthma protocol ( Figure 1). This new protocol streamlined clinical care and instituted four new interventions: initiation of nebulized short acting agonists (SABA) prior to or concurrent with physician evaluation, objective pre and post treatment measurements of AAE severity though the use of percent predicted Forced Expired Volume 1 (ppFEV1), SABA administration via breath actuated nebulizer rather than traditional continuous flow nebulizers [12], and the development and implementation of an individual Asthma Action Plan ( Figure 2) for discharged patients. It was hypothesized implementation of a standardized Asthma Treatment Protocol (ATP) within the ED will improve average ED LOS and prevent return visits to the ED within 24 hours.…”