Protocol and Statistical Analysis Plan for a Multicenter Randomized Trial of Ketamine vs Etomidate for Emergency Tracheal Intubation
Year: 2025
Type: article
Study design: Study Protocol
Abstract: BACKGROUND: Emergency tracheal intubation is a common and high-risk procedure. Ketamine and etomidate are medicines commonly used to induce anesthesia for emergency tracheal intubation, but whether the induction medication used affects patient outcomes is uncertain. 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.
Source: CHEST Critical Care
Authors: Stephanie C. DeMasi, Brant Imhoff, Ariel A. Lewis, Kevin P. Seitz, Brian E. Driver, Kevin W. Gibbs, Adit A. Ginde, Stacy A. Trent, Derek W. Russell, Amelia L. Muhs, Matthew E. Prekker, John P. Gaillard, Daniel Resnick-Ault, L. Jane Stewart, Micah R. Whitson, Graham W.W. Van Schaik, Aaron E. Robinson, Jessica A. Palakshappa, Neil R. Aggarwal, Jason C. Brainard, David J. Douin, Carolynn Lyle, Sheetal Gandotra, Aaron J. Lacy, Kristen C. Sherlin, Greta K. Carlson, J. Maycee Cain, Brianne Redman, Carrie Higgins, Cori Withers, Logan L. Beach, Barbara Gould, Jasmine McIntosh, Bradley D. Lloyd, Tiffany L. Israel, Li Wang, Todd W. Rice, Wesley H. Self, Jin H. Han, Jonathan D. Casey, Matthew W. Semler
Institution: Vanderbilt University Medical Center
Language: English
Subfield: Anesthesiology and Pain Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,500
Funders: U.S. Department of Defense, Patient-Centered Outcomes Research Institute, National Institutes of Health, Centers for Disease Control and Prevention, National Heart, Lung, and Blood Institute, National Institute of General Medical Sciences, National Center for Advancing Translational Sciences, NHLBI Division of Intramural Research
Awards: G33145557, Bag-Mask Ventilation to PreVent Hypoxemia during Tracheal Intubation in the Emergency Department: A Clinical Trial, G8994981492, Clinical and Translational Training Program in Pulmonary Medicine, Restoring Endothelial Function After Traumatic Injury to Reduce ARDS and Multi-Organ Dysfunction, Intubation with Sedation Only to Prevent Hypoxemia during Emergency Tracheal Intubation of Critically Ill Adults: A Randomized Clinical Trial, TIPS: Training in Perioperative Science
OpenAlex ID: W4410578331