CLINICAL TRIAL: TREATMENT OF OXYGEN AT HIGH DOSES IN CHILDREN WITH ASTHMA CRISIS MODERATE / SEVERE IN THE EMERGENCY UNIT

• Conditions: 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]

• Registration Number: EUCTR2012-001771-36-ES
• Lead Sponsor: FRANCISCO JAVIER BENITO FERNANDEZ

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-25
• Last Update Posted: 3 September 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 0

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 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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.<br>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<br>Efficacy : total failure and success of treatment;Timepoint(s) of evaluation of this end point: After 36 hours

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Efficacy: Relative failure<br><br>Security. proportion of day/stay in hospital. proportion of patients with improvement criteria <br><br>Number of Salbutamol/hour doses;Timepoint(s) of evaluation of this end point: After 36 hours