NCT01320384

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

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)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 313 (actual)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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 : 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).

Conditions

• Acute Lung Injury
• Acute Respiratory Failure

Interventions

Type	Name	Description
OTHER	O2 conventional	standard low flow therapy
DEVICE	O2-HFN : high flow nasal oxygen therapy	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%.
DEVICE	O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilation	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.

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2011-03-22
• Last updated: 2016-10-11

Locations

1 site across 1 country: France