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Usefulness of the new SOBIstat-F® device in children with severe acute asthma attacks in the Emergency Department: A randomized clinical trial.
  • +6
  • Ricardo Iramain,
  • Castro-Rodríguez José,
  • Newhouse Michael,
  • Goldman Peter,
  • Ortiz Jorge,
  • Alfredo Jara,
  • Laura Cardozo,
  • Rocio Morinigo,
  • Katia Martinez
Ricardo Iramain
Universidad Nacional de Asuncion Facultad de Ciencias Medicas

Corresponding Author:[email protected]

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Castro-Rodríguez José
Pontificia Universidad Catolica de Chile
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Newhouse Michael
McMaster University
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Goldman Peter
Andrews Air Force Base
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Ortiz Jorge
Universidad Nacional de Asuncion Facultad de Ciencias Medicas
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Alfredo Jara
Universidad Nacional de Asuncion Facultad de Ciencias Medicas
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Laura Cardozo
Universidad Nacional de Asuncion Facultad de Ciencias Medicas
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Rocio Morinigo
Universidad Nacional de Asuncion Facultad de Ciencias Medicas
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Katia Martinez
Hospital General de Barrio Obrero
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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.
11 Sep 2024Submitted to Pediatric Pulmonology
11 Sep 2024Submission Checks Completed
11 Sep 2024Assigned to Editor
11 Sep 2024Review(s) Completed, Editorial Evaluation Pending
20 Oct 2024Reviewer(s) Assigned