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Clinical Trials/EUCTR2012-001771-36-ES
EUCTR2012-001771-36-ESActive, not recruitingNot Applicable

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

FRANCISCO JAVIER BENITO FERNANDEZ0 sites0 target enrollmentStarted: June 25, 2012Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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.

Investigators

Sponsor
FRANCISCO JAVIER BENITO FERNANDEZ

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