Protocol and Statistical Analysis Plan for a Multicenter Randomized Trial of Ketamine vs Etomidate for Emergency Tracheal Intubation.
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DeMasi Stephanie C, Imhoff Brant, Lewis Ariel A, Seitz Kevin P, Driver Brian E, Gibbs Kevin W, Ginde Adit A, Trent Stacy A, Russell Derek W, Muhs Amelia L, Prekker Matthew E, Gaillard John P, Resnick-Ault Daniel, Stewart L Jane, Whitson Micah R, Van Schaik Graham W W, Robinson Aaron E, Palakshappa Jessica A, Aggarwal Neil R, Brainard Jason C, Douin David J, Lyle Carolynn, Gandotra Sheetal, Lacy Aaron J, Sherlin Kristen C, Carlson Greta K, Maycee Cain J, Redman Brianne, Higgins Carrie, Withers Cori, Beach Logan L, Gould Barbara, McIntosh Jasmine, Lloyd Bradley D, Israel Tiffany L, Wang Li, Rice Todd W, Self Wesley H, Han Jin H, Casey Jonathan D, Semler Matthew W
Аннотация
RESEARCH QUESTION: Does the use of ketamine for induction of anesthesia decrease the incidence of death among adults undergoing emergency tracheal intubation compared with the use of etomidate?
STUDY DESIGN AND METHODS: The Randomized Trial of Sedative Choice for Intubation (RSI) is a pragmatic, multicenter, unmasked, parallel-group randomized trial being conducted at 14 sites (6 emergency departments and 8 ICUs) in the United States. The trial compares ketamine vs etomidate for induction of anesthesia among 2,364 critically ill adults undergoing emergency tracheal intubation. The primary outcome is all-cause 28-day in-hospital mortality. The secondary outcome is the incidence of cardiovascular collapse during intubation, a composite of hypotension, receipt of vasopressors, and cardiac arrest.
RESULTS: Enrollment began on April 6, 2022, and is expected to conclude in 2025.
INTERPRETATION: The RSI will provide important data on the effects of ketamine vs etomidate on death and other outcomes for critically ill adults undergoing emergency tracheal intubation. Specifying the protocol and statistical analysis plan before the conclusion of enrollment increases the rigor, reproducibility, and transparency of the trial.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT05277896; URL: www.clinicaltrials.gov.