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

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Acute Lung Injury, Acute Respiratory Failure

Intervention / Treatment
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* Other: O2 conventional
* Device: O2-HFN : high flow nasal oxygen therapy
* Device: O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: O2 conventional : standard low flow therapy<br>in order to obtain a SpO2>92% | Other: O2 conventional<br>* standard low flow therapy<br>|
| Experimental: O2-HNF : high flow nasal oxygen therapy<br>set between 30 to 50 l/min,adjusted in order to obtain a SpO2 >92%. | Device: O2-HFN : high flow nasal oxygen therapy<br>* 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%.<br>|
| Experimental: O2-HFN/NPPV<br>cycling of NIV and O2-HDN | Device: O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation |  | at day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mechanical ventilation-free to day 28 |  | 28 days | 
| ICU morbidity |  | at day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALI