Clinical Effect of the Association of Noninvasive Ventilation and High Flow Nasal Oxygen Therapy in Resuscitation of Patients With Acute Lung Injury. A Randomised Study (FLORALI Study)

Poitiers University Hospital1 site in 1 country313 target enrollmentMarch 2011

ConditionsAcute Lung Injury Acute Respiratory Failure

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Acute Lung Injury
Sponsor: Poitiers University Hospital
Enrollment: 313
Locations: 1
Primary Endpoint: To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of the study is to compare, in patients with acute respiratory failure/acute lung injury the efficacy of three different methods of oxygenation to prevent endotracheal intubation :

conventional oxygen therapy (O2 conventional)
high flow nasal oxygen therapy (O2-HFN)
association of high flow nasal oxygen therapy with non invasive positive pressure ventilation (O2-HFN/NPPV).

Registry

clinicaltrials.gov

Start Date

March 2011

End Date

July 2013

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Poitiers University Hospital

Eligibility Criteria

Inclusion Criteria

•Hypoxemic and no hypercapnic acute respiratory failure :
•severe dyspnea at rest with a respiratory rate \>25 breaths/min
•PaO2/FiO2 \<300
•PaCO2 \<45 mmHg,

Exclusion Criteria

•age \<18 years
•NPPV contraindications
•past history of respiratory chronic disease (COPD, cystic fibrosis...)
•cardiac pulmonary edema
•Pre-defined intubation
•other than respiratory organ failure : systolic pressure \<90 mmHg,current treatment with epinephrine or norepinephrine, decreased level of consciousness ( Glasgow score ≤ 12)
•profound aplasia (white cells count \<1000/mm 3)