Study outcomes
respiratory failure, cardiac arrest, organ dysfunction, hypoxemia, acute respiratory failure
RESPIRATORY FAILURE, HEMODYNAMIC INSTABILITY, CARDIAC ARREST, ACUTE RESPIRATORY FAILURE
The main study outcome was the need for endotracheal intubation for respiratory failure within 14 days after randomization and/or end-of-hospitalization. To ensure consistency of indications between sites and to reduce the risk of delayed intubation, the following criteria for endotracheal intubation were used: cardiac arrest or significant hemodynamic instability, worsening of neurologic status, acute respiratory failure defined by at least two of the following criteria: respiratory rate ≥ 35 / min, high respiratory-muscle workload, abundant tracheal secretions, signs of respiratory exhaustion (pH < 7.32 or PaCOA rescue NIV trial was allowed at the discretion of the physician in patients with acute respiratory failure and no other organ dysfunction. The persistence of worsening of acute respiratory failure or severe hypoxemia after 1 h of NIV or in patients with NIV-intolerance were considered as criteria for endotracheal intubation [Secondary outcomes were the time-course PaO