The goal of this clinical trial is to determine whether one of the two oxygenation or ventilation strategies (NIV and/or HFNO) is superior to standard oxygen to reduce 28-day mortality rate in hypoxemic acute respiratory failure (ARF) patients.
This randomized controlled trial is a superiority study to test if one of the methods (NIV and/or HFNO) is superior to standard oxygen in ARF patients requiring oxygen. It is an investigator-initiated, multicenter, adaptive, three arms parallel-group trial with a computer-generated allocation sequence and an electronic system-based randomization, with a stratification on medical (then stratification between immunocompromised and non-immunocompromised patients) versus surgical (then stratification between cardiothoracic and abdominal patients).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,100
Standard oxygen therapy administered through a Venturi mask allowing a fraction of inspired oxygen (FiO2) setting to maintain a peripheral oxygen saturation (SpO2) ≥ 94%. For medical reasons left to the clinician appreciation (such as a COPD or pulmonary fibrosis or other conditions), a SpO2 ≥ 90% will be accepted.
The oxygen therapy will be administered in a semi-sitting position, with a setting of the FiO2 and the oxygen flow rate, to obtain a SpO2 ≥ 94%. For medical reasons left to the clinician appreciation (such as a COPD or pulmonary fibrosis or other conditions), a SpO2 ≥ 90% will be accepted.
Systematic application of NIV using two levels of pressure, pressure support (PS) + positive end-expiratory pressure (PEEP) provided using a dedicated NIV ventilator or a standard ICU ventilator with the " NIV module " through a facial mask. The FiO2 will be set to obtain a SpO2 ≥ 94%. For medical reasons left to the clinician appreciation (such as a COPD or pulmonary fibrosis or other conditions), a SpO2 ≥ 90% will be accepted.
Montpellier University Hospital - Saint Eloi Hospital
Montpellier, France
RECRUITINGDay-28 mortality
Mortality rates at Day-28
Time frame: Up to Day-28
Intubation rate at Day-28
Proportion of patients requiring invasive mechanical ventilation
Time frame: Day-28
Intubation rate at Day-3
Proportion of patients requiring invasive mechanical ventilation
Time frame: Day-3
Intubation rate at Day-7
Proportion of patients requiring invasive mechanical ventilation
Time frame: Day-7
Oxygenation up to Day-7
Proportion of patients with better oxygenation
Time frame: Up to Day-7
Need of other rescue oxygen therapy up to Day-7
Proportion of patients requiring rescue oxygen therapy
Time frame: Up to Day-7
ICU length of stay
Duration time in ICU
Time frame: Up to Day-90
Hospital length of stay
Duration time in Hospital
Time frame: Up to Day-90
Mortality rates in ICU
Mortality rates in ICU
Time frame: Up to Day-90
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Mortality rates in hospital
Mortality rates in hospital
Time frame: Up to Day-90
Day-90 mortality
Mortality rates at Day-90
Time frame: Day-90
Adverse events
Related to the treatment
Time frame: Up to Day-90