Oxygen supplementation in patients with acute pulmonary failure admitted to the intensive care unit: a clinical trial of two seperate levels of oxygen supplementation during treatment in the intensive care unit

INTERVENTION: Pharmaceutical Form: Medicinal gas, cryogenic CONDITION: Acute hypoxaemic respiratory failure in patients admitted to the intensive care unit ; MedDRA version: 20.0 Level: PT Classification code 10001053 Term: Acute respiratory failure System Organ Class: 10038738 ‐ Respiratory, thoracic and mediastinal disorders ; MedDRA version: 20.0 Level: PT Classification code 10022519 Term: Intensive care System Organ Class: 10042613 ‐ Surgical and medical procedures Therapeutic area: Diseases [C] ‐ Respiratory Tract Diseases [C08] PRIMARY OUTCOME: Main Objective: To assess the benefits and harms of two targets of partial pressure of oxygen in arterial blood in guiding the oxygen administration in acutely ill adults with hypoxaemic respiratory failure at ICU admission. Primary end point(s): Mortality Secondary Objective: To asses health economic implications of two targets of partial pressure of oxygen in arterial blood in guiding the oxygen administration in acutely ill adults with hypoxaemic respiratory failure at ICU admission. Conducted through a health economic analysis at one year follow‐up of the last enrolled patient. Timepoint(s) of evaluation of this end point: 90 days post‐randomisation SECONDARY OUTCOME: Secondary end point(s): ‐ Number of patients with one or more SAEs in the ICU after randomisation; SAEs are defined as new episode of shock and new episodes of ischemic events including myocardial or intestinal ischaemia or ischemic stroke in the 90‐day period ; ‐ Days alive without the use of respiratory support, renal replacement therapy or circulatory support in the 90‐day period ; ‐ Days alive out of the hospital in the 90‐day period ; ‐ Mortality 1‐year after randomisation ; ‐ Health related quality of life (Euroqual, EQ‐5D‐5L) 1‐year after randomisation. ; ‐ Cognitive function 1‐year after randomisation as assessed using RBANS score in selected sites ; ‐ A health economic analysis based on the result of the trial and specified (cost‐effectiveness versus cost‐minimisation analyses) Timepoint(s) of evaluation of this end point: See description in E.5.2 INCLUSION CRITERIA: ‐ Acutely admitted to the intensive care unit AND ‐ Aged = 18 years AND ‐ Receive supplemental oxygen with a flow of at least 10 L per minute in an open system or at least an fraction of inspired oxygen of 0.50 in a closed system, including invasive ventilation, non‐invasive ventilation or continuous positive airway pressure AND ‐ Are expected to receive oxygen administration for at least 24 hours in the ICU AND ‐ Have an arterial line in place Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 1312 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1616