The purpose of this study is to determine whether, as compared with the Venturi mask, a nasal, high-flow oxygenation device (Optiflow) may reduce the extubation failure rate in patients needing oxygen therapy after extubation.
This study compares the effects of two devices for oxygen therapy, the nasal, high-flow (Optiflow, intervention) and the Venturi mask (control), on the outcome of extubation. Available data suggest that Optiflow can improve oxygenation and patient's comfort in critically ill patients after extubation. The study hypothesis is that Optiflow may reduce the extubation failure rate in these patients. In the intervention group, patients fulfilling inclusion criteria and not presenting any of the exclusion criteria will receive high-flow oxygen through nasal cannula (Optiflow, Fisher \& Paykel Healthcare Ltd., New Zealand) after extubation. The oxygen concentration (FiO2) will be set to reach an oxygenation target similar to control patients (see below), while the gas flow rate will be set at 50 L/min. In the control group, patients fulfilling inclusion criteria and not presenting any of the exclusion criteria will receive oxygen through a standard Venturi mask after extubation. The FiO2 will be set to obtain a arterial oxygen saturation (SpO2) between 92% and 98% (or between 88% and 95% in hypercapnic patients). Further FiO2 modifications will be performed by the attending physicians to meet the oxygenation target.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
500
This device delivers high-flow oxygen through nasal cannula
This device delivers low-flow oxygen at predetermined concentrations
Sainte-Marguerite University Hospital
Marseille, France
Lapeyronie University Hospital
Montpellier, France
Saint Eloi University Hospital
Montpellier, France
Reintubation
Time frame: within 72 hours after extubation or at ICU discharge
Need for Non-Invasive Ventilation
Time frame: at day 28 after inclusion in the study or at ICU discharge
ICU length of stay
Time frame: at day 28 from the inclusion in the study or at ICU discharge
Hospital length of stay
Time frame: at day 28 from the inclusion in the study or at hospital discharge
ICU readmission
Time frame: at day 28 from inclusion in the study
ICU mortality
Time frame: at day 28 from inclusion in the study
Hospital mortality
Time frame: at day 28 from inclusion in the study
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La Pitie-Salpetriere University Hospital
Paris, France
Louis Mourier University Hospital
Paris, France
Saint-Louis University Hospital
Paris, France
University Hospital
Poitiers, France
Evangelismos University Hospital
Athens, Greece
Policlinico University Hospital
Bari, Italy
Università del Piemonte Orientale, Ospedale della Carità
Novara, Italy
...and 4 more locations