PILOT CLINICAL TRIAL, RANDOMIZED AND CONTROLLED OF THE USE-OF OXYGEN AT HIGH FLOW IN CHILDREN IN THE PEDIATRIC EMERGENCY SERVICE. COD: OXAURP

INTERVENTION: Trade Name: OXIGENO MEDICINAL LIQUIDO EN RECIPIENTE CRIOGENICO FIJO Product Name: OXIGENO Product Code: OXIGENO Pharmaceutical Form: Gas and solvent for dispersion for injection/infusion INN or Proposed INN: OXIGENO CAS Number: 7782‐44‐7 Current Sponsor code: . Other descriptive name: OXYGEN Concentration unit: % percent Concentration type: range Concentration number: 70‐100 CONDITION: Objectives: To evaluate the feasibility and explore the efficacy, safety and tolerability of the administration of oxygen at high flow during the stay of these children in the Pediatric Emergency Department (PED) to prevent hospitalization Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Therapeutic techniques [E02] PRIMARY OUTCOME: Main Objective: Assess the feasibility (adequacy and coordination of resources) from the OAF management in children with asthma and moderate to severe respiratory failure and / or high oxygen needs within a PED.; Assess the efficacy of the OAF in the management of children with asthma and moderate to severe respiratory failure and / or high oxygen needs. Primary end point(s): Feasibility: professional initial acceptability and parents/tutor initial acceptability; Efficacy : total failure and success of treatment Secondary Objective: Assess the safety and tolerance of the treatment given in this context.; Assess organizational changes and adaptations to optimize the use of OAF if proved feasible. Timepoint(s) of evaluation of this end point: After 36 hours SECONDARY OUTCOME: Secondary end point(s): Efficacy: Relative failure; ; Security. proportion of day/stay in hospital. proportion of patients with improvement criteria ; ; Number of Salbutamol/hour doses Timepoint(s) of evaluation of this end point: After 36 hours INCLUSION CRITERIA: INCLUSION CRITERIA: 1) Children admitted to the SUP, ages 1 and 14 years, 2) with acute asthma: any child with respiratory symptoms (cough, respiratory distress, tachypnea) attributed to bronchospasm (wheezing, expiratory elongated, hypoventilation , etc ...), regardless the possible trigger (infection, mites, pollens, etc ...) or the presence or absence of previous episodes.3) that meets at least one of the following criteria, moderate‐severe respiratory failure (Pulmonary score ? 6) despite initial treatment with nebulized salbutamol every 20 minutes during the first hour (at least 3 doses): (Appendix 2). High O2 needs: O2 sat <90% with FiO2 40, detection by capnography (EtCO2) or blood gas pCO2> 45 mm Hg, 4) Parents and / or legal representatives agree to participate in the study. Are the trial subjects under 18? yes Number of subjects for this age range: 120 F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Eld