Weaning protocol for high-flow nasal oxygen therapy in the ICU - Multicenter randomized controlled trial. HiFloWEAN

INTERVENTION: Product Name: OXYGENE MEDICINAL LIQUIDE AIR LIQUIDE SANTE FRANCE, gaz pour inhalation, pour évaporateur fixe,Product Code: PRD370798,Pharmaceutical Form: MEDICINAL GAS, CRYOGENIC,Other descriptive name: ,Strength: Oxygen 100% CONDITION: de novo acute respiratory failure ; MedDRA version: 21.0Level: LLTClassification code: 10000953Term: Acute on chronic respiratory failureSystem Organ Class: 10038738 MedDRA version: 21.0Level: LLTClassification code: 10000953Term: Acute on chronic respiratory failureSystem Organ Class: 10038738 Therapeutic area: Diseases [C] ‐ Respiratory Tract Diseases [C08] PRIMARY OUTCOME: Main Objective:To show that the use of a protocol for weaning patients from High‐Flow Nasal Oxygen Therapy increases the probability that patients will be weaned from High‐Flow Nasal Oxygen Therapy at D7 post‐randomization. Primary end point(s):The primary endpoint was the success rate at D7, with success defined as "definitive" weaning from high‐flow nasal oxygen therapy, i.e. patients weaned for more than 48 hours from high‐flow nasal oxygen therapy without recourse to non‐invasive ventilation or intubation and alive at D7. Secondary Objective:To show that the use of a high‐flow nasal oxygen weaning protocol increases the probability that the patient will be weaned from high‐flow nasal oxygen therapy at D28 post‐randomization.,Compare the incidence of intubation, use of curative non‐invasive ventilation or death up to D28.,Describe the duration of use of high‐flow nasal oxygen therapy in patients weaned from high‐flow nasal oxygen therapy,Study the evolution of the ROX index during the weaning phase,Study the evolution of accessory respiratory muscle activation and dyspnea during the weaning phase,Compare length of stay in intensive care and/or continuous care units,ntensive care unit and/or continuous monitoring unit and the discharge from the intensive care unit OR the ability to be discharged from the intensive care unit SECONDARY OUTCOME: Secondary end point(s):Cumulative incidence of curative non‐invasive ventilation up to D28 Secondary end point(s):Cumulative incidence of intubation up to D28 Secondary end point(s):Duration of stay between admission to the intensive care and/or continuous monitoring unit and discharge from intensive care OR the ability to be discharged from intensive care assessed through an aptitude assessment grid. The ability to be discharged from intensive care/continuous monitoring will be defined by the validation of all items on the modified aptitude assessment grid (see appendix). Secondary end point(s):Evolution of accessory respiratory muscle engagement by Patrick score Secondary end point(s):Evolution of RO Xinde Xduring weaning phase Secondary end point(s):Length of stay in intensive care and/or continuous care unit Secondary end point(s):Mortality rate at D28 Secondary end point(s):Number of days on high‐flow nasal oxygen therapy in patients permanently weaned from high‐flow nasal oxygen therapy between randomization and discharge from intensive care or at D28 Secondary end point(s):Progression of dyspnoea assessed by the modified Borg scale Secondary end point(s):Time to definitive weaning from high‐flow nasal oxygen therapy between randomization and D28 Secondary end point(s):Weaning rate from high‐flow nasal oxygen therapy at D28 INCLUSION CRITERIA: Major patient (=18 years old) admitted to the ICU or intensive care unit for acute hypoxemic respiratory failure de novo (with a PaO2/FiO2 ratio <300 mmHg).,Treated with high‐flow nasal oxygen therapy with a flow rate = 50L/min and inspired oxygen fraction (FiO2) = 0.5, with flow rate and FiO2 stable (i.e. not increased) in the 24 hours prior to inclusion,With RO Xinde X(SpO2/FiO2/Respiratory Rate) stable or improving in the 6 hours prior to inclusion and greater than 4.88,Having had a gas measurement under high‐flow nasal oxygen therapy within 24 hours of inclusion,Patient affiliated to a social security scheme,Written consent signed by the patient (by the designated person of trust, a parent, or a close relative in case the patient is incapacitated; this consent must subsequently be confirmed by the patient as soon as they are able to do so)