Usefulness of the new SOBIstat-F® device in children with severe acute
asthma attacks in the Emergency Department: A randomized clinical trial.
Abstract
Background: Current protocols for the management of severe
asthma exacerbations include step therapy with bronchodilators
(short-acting beta 2-agonists, and ipratropium bromide) administered by
nebulizer or meter doses inhaler (MDI) with a valved holding chamber,
corticosteroids, and magnesium sulfate EV. This study aims to evaluate
the effectiveness of a new device (SOBIstat-F ®) for
bronchodilator administration via MDI compared to the conventional
method. Methods: A randomized clinical trial was conducted in
children with severe acute asthma seen in two pediatric emergency
departments. Patients were assigned to one of the following groups:
MDI-SOBx in which they received bronchodilators in MDI through the
SOBIstat-F® device, or in MDI with oxygen via cannula or mask
(MDI-OxStand). The main outcome was the need for hospitalization at the
end of 8 hours of treatment. Results: 84 patients participated
in the study, of which 43 were treated with the MDI-SOBx device and 41
with MDI-OxStand. There were no differences in demographic
characteristics or severity of the exacerbations between the groups.
Those children treated with MDI-SOBx had a lower hospitalization rate
versus those with the MDI-OxStand (9.3% vs. 26.8%, respectively,
p=0.036). Also, a significant clinical improvement (pulmonary score) was
observed from 90 minutes (p<0.001) and oxygen saturation from 60
min (p<0.001) in children in the MDI-SOBx group. Side effects
were similar. Conclusions: The administration of
bronchodilators using the SOBIstat-F ® device
demonstrated, for the first time, to be more effective than the
conventional method in reducing hospitalizations and in the clinical
improvement of children with severe asthma exacerbations.