Protocol and Statistical Analysis Plan for the Randomized Trial of Sedative Choice for Intubation (RSI).
medRxiv : the preprint server for health sciences January 18, 2025 Stephanie C. DeMasi, Brant Imhoff, Ariel A. Lewis et al. preprint
Among critically ill adults undergoing emergency tracheal intubation, it is uncertain whether the choice of ketamine or etomidate for induction of anesthesia affects patient outcomes. The Randomized trial of Sedative choice for Intubation (RSI) is a pragmatic, multicenter trial enrolling 2,364 patients across 14 U.S. sites to compare ketamine versus etomidate. The primary outcome is all-cause, 28-day in-hospital mortality; a secondary outcome is cardiovascular collapse during intubation. Enrollment began in April 2022 and is expected to conclude in 2025. Prespecifying the protocol and statistical analysis plan before enrollment ends increases the trial's rigor, reproducibility, and transparency.