Protocol and statistical analysis plan for the PREOXI trial of preoxygenation with noninvasive ventilation vs oxygen mask.

Background: Hypoxemia is a common and life-threatening complication during emergency tracheal intubation of critically ill adults. The administration of supplemental oxygen prior to the procedure ("preoxygenation") decreases the risk of hypoxemia during intubation.
Research Question: Whether preoxygenation with noninvasive ventilation prevents hypoxemia during tracheal intubation of critically ill adults, compared to preoxygenation with oxygen mask, remains uncertain.
Study Design and Methods: The PRagmatic trial Examining OXygenation prior to Intubation (PREOXI) is a prospective, multicenter, non-blinded randomized comparative effectiveness trial being conducted in 7 emergency departments and 17 intensive care units across the United States. The trial compares preoxygenation with noninvasive ventilation versus oxygen mask among 1300 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 prior to induction. The primary outcome is the incidence of hypoxemia, defined as a peripheral oxygen saturation <85% between induction and 2 minutes after intubation. The secondary outcome is the lowest oxygen saturation between induction and 2 minutes after intubation. Enrollment began on 10 March 2022 and is expected to conclude in 2023.
Interpretation: The PREOXI trial will provide important data on the effectiveness of noninvasive ventilation and oxygen mask preoxygenation for the prevention of hypoxemia during emergency tracheal intubation. Specifying the protocol and statistical analysis plan prior to the conclusion of enrollment increases the rigor, reproducibility, and interpretability of the trial.
Clinical Trial Registration Number: NCT05267652.
Competing Interests: Conflicts of Interest and Financial Disclosures: Kevin W. Gibbs MD reports financial support and travel were provided by US Department of Defense. Adit. A. Ginde MD MPH reports financial support was provided by US Department of Defense. Matthew E. Prekker MD MPH reports financial support was provided by US Department of Defense. Kevin P. Seitz MD MSc reports financial support was provided by National Heart Lung and Blood Institute. Susan B. Stempek PA MBA reports financial support was provided by American College of Chest Physicians. Akram Khan MD reports financial support was provided by United Therapeutics Corporation. Akram Khan MD reports financial support was provided by 4D Medicine Ltd. Akram Khan MD reports financial support was provided by Regeneron Pharmaceuticals Inc. Akram Khan MD reports financial support was provided by Roche. Akram Khan MD reports financial support was provided by Dompé pharmaceutical. Jessica A. Palakshappa MD MS reports financial support was provided by National Institute on Aging. Joanne M. Wozniak PA MS reports was provided by American College of Chest Physicians. Matthew C. Exline MD, MPH reports financial support was provided by Abbott Laboratories. Derek W. Russell MD reports financial support was provided by National Heart Lung and Blood Institute. Shekar Ghamande MD reports financial support was provided by US Department of Defense. Ari Moskowitz MD MPH reports financial support was provided by National Heart Lung and Blood Institute. Jill Bastman BSN reports financial support was provided by US Department of Defense. Micah T. Long MD reports financial support was provided by pocket cards. Steven G. Schauer DO MS reports was provided by US Department of Defense. David Janz MD MSc reports financial support was provided by US Department of Defense. Matthew W. Semler MD MSc reports financial support was provided by US Department of Defense. Matthew W. Semler MD MSc reports financial support was provided by National Heart Lung and Blood Institute. Jonathan D. Casey MD MSc reports was provided by US Department of Defense. Jonathan D. Casey MD MSc reports was provided by National Heart Lung and Blood Institute. Jonathan D. Casey MD MSc reports travel was provided by Fisher & Paykel Healthcare Inc. Todd W Rice MD MSc reports a relationship with Cumberland Pharmaceuticals Inc that includes: consulting or advisory and equity or stocks. Derek W. Russell MD reports a relationship with Achieve Life Science Inc that includes: equity or stocks. Matthew W. Semler MD MSc reports a relationship with Baxter International Inc that includes: consulting or advisory.