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

Poitiers University Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Acute Lung Injury; Acute Respiratory Failure

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01320384

FLORALI

Details and patient eligibility

About

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).

Enrollment: 313 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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313 participants in 3 patient groups

O2 conventional : standard low flow therapy

Active Comparator group

Description:

in order to obtain a SpO2\>92%

Treatment:

Other: O2 conventional

O2-HNF : high flow nasal oxygen therapy

Experimental group

Description:

set between 30 to 50 l/min,adjusted in order to obtain a SpO2 \>92%.

Treatment:

Device: O2-HFN : high flow nasal oxygen therapy

O2-HFN/NPPV

Experimental group

Description:

cycling of NIV and O2-HDN

Treatment:

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