Protocol and Statistical Analysis Plan for the Pragmatic Trial Examining Oxygenation Prior to Intubation of Preoxygenation With Noninvasive Ventilation vs Oxygen Mask in Critically Ill Adults

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Background Hypoxemia is a common and life-threatening complication during emergency tracheal intubation of critically ill adults. The administration of supplemental oxygen before the procedure (ie, preoxygenation) decreases the risk of hypoxemia during intubation. Research Question Does preoxygenation with noninvasive ventilation prevent hypoxemia during tracheal intubation of critically ill adults compared with preoxygenation with an oxygen mask? Study Design and Methods The Pragmatic Trial Examining Oxygenation Prior to Intubation (PREOXI) is a prospective, multicenter, nonmasked randomized comparative effectiveness trial being conducted in seven EDs and 17 ICUs across the United States. The trial compares preoxygenation with noninvasive ventilation vs oxygen mask among 1,300 critically ill adults undergoing emergency tracheal intubation. Eligible patients are randomized in a 1:1 ratio to receive either noninvasive ventilation or an oxygen mask before induction. The primary outcome is the incidence of hypoxemia, defined as a peripheral oxygen saturation of < 85% between induction and 2 min after intubation. The secondary outcome is the lowest oxygen saturation between induction and 2 min after intubation. Enrollment began on March 10, 2022, and is expected to conclude in 2023. Interpretation The PREOXI investigation will provide important data on the comparative effectiveness of preoxygenation with noninvasive ventilation vs oxygen mask for the prevention of hypoxemia during emergency tracheal intubation. Specifying the protocol and statistical analysis plan before the conclusion of enrollment increases the rigor, reproducibility, and interpretability of the trial. Trial Registry ClinicalTrials.gov; No.: NCT05267652; URL: www.clinicaltrials.gov

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