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
Conditions
Interventions
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 Propos
Sponsors
FRANCISCO JAVIER BENITO FERNANDEZ
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1) Patients with other airway pathology that does not define as asthma.2) Patients with concomitant diseases that make advisable it´s admission.3) Patients requiring advanced air way stabilization.4) Any cultural, social problem, disease or problem of any kind that do assume the possible lack of cooperation from the patient and / or their legal representatives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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.;Primary end point(s): Feasibility: professional initial acceptability and parents/tutor initial acceptability Efficacy : total failure and success of treatment;Timepoint(s) of evaluation of this end point: After 36 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Spain
Contacts
Public ContactUNIDAD DE INVESTIGACIÓN
HOSPITAL UNIVERSITARIO CRUCES
Outcome results
None listed