Clinical Effect of the Association of Noninvasive Ventilation and High Flow Nasal Oxygen Therapy in Resuscitation of Patients With Acute Lung Injury (FLORALI Study) (FLORALI)
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|ClinicalTrials.gov Identifier: NCT01320384|
Recruitment Status : Completed
First Posted : March 22, 2011
Last Update Posted : October 11, 2016
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).
|Condition or disease||Intervention/treatment||Phase|
|Acute Lung Injury Acute Respiratory Failure||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||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||313 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
Active Comparator: O2 conventional : standard low flow therapy
in order to obtain a SpO2>92%
Other: O2 conventional
standard low flow therapy
Experimental: O2-HNF : high flow nasal oxygen therapy
set between 30 to 50 l/min,adjusted in order to obtain a SpO2 >92%.
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%.
cycling of NIV and O2-HDN
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.
- To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation [ Time Frame: at day 28 ]
- mechanical ventilation-free to day 28 [ Time Frame: 28 days ]
- ICU morbidity [ Time Frame: at day 28 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01320384
|Poitiers University Hospital|
|Poitiers, France, 86021|