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

Phase 3CompletedNCT01320384

Poitiers University Hospital313 enrolled

Overview

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 : 1. conventional oxygen therapy (O2 conventional) 2. high flow nasal oxygen therapy (O2-HFN) 3. association of high flow nasal oxygen therapy with non invasive positive pressure ventilation (O2-HFN/NPPV).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

313

Conditions

Acute Lung Injury Acute Respiratory Failure

Interventions

O2-HFN : high flow nasal oxygen therapyDEVICE

The patient will receive high flow nasal of humidified oxygen, set between 30 to 50 l/min. The inspired fraction of oxygen (FiO2) will be adjusted in order to obtain a SpO2 \>92%.

O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilationDEVICE

The patient will receive successively in a day NPPV and O2-HFN. The NPPV will be applied with an airway humidification achieved by using a heated humidifier and a facial mask adapted to the morphology of the patient. The settings will be adjusted as follow : an inspiratory pressure between 6 to 14 cmH2O, in order to obtain a tidal volume between 7 to 10 ml/kg of predicted weight, a positive expiratory pressure between 0 to 10 cmH2O in order to obtain a SpO2 \>92% with the minimal FiO2.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation

Time frame: at day 28

Secondary Outcomes

mechanical ventilation-free to day 28

Time frame: 28 days

ICU morbidity