CHEST Critical Care (Sep 2025)
Protocol and Statistical Analysis Plan for a Multicenter Randomized Trial of Ketamine vs Etomidate for Emergency Tracheal IntubationTake-Home Points
- Stephanie C. DeMasi, MD,
- Brant Imhoff, MS,
- Ariel A. Lewis, BSN, RN, MPH,
- Kevin P. Seitz, MD,
- Brian E. Driver, MD,
- Kevin W. Gibbs, MD,
- Adit A. Ginde, MD, MPH,
- Stacy A. Trent, MD, MPH,
- Derek W. Russell, MD,
- Amelia L. Muhs, MD,
- Matthew E. Prekker, MD, MPH,
- John P. Gaillard, MD,
- Daniel Resnick-Ault, MD,
- L. Jane Stewart, MD, JD, MPH,
- Micah R. Whitson, MD,
- Graham W.W. Van Schaik, MD, MBA,
- Aaron E. Robinson, MD, MPH,
- Jessica A. Palakshappa, MD,
- Neil R. Aggarwal, MD, MHSc,
- Jason C. Brainard, MD,
- David J. Douin, MD,
- Carolynn Lyle, PA-C, MPH,
- Sheetal Gandotra, MD,
- Aaron J. Lacy, MD,
- Kristen C. Sherlin, PharmD,
- Greta K. Carlson, MD,
- J. Maycee Cain, BS,
- Brianne Redman, MD,
- Carrie Higgins, BSN,
- Cori Withers, BS,
- Logan L. Beach, MD,
- Barbara Gould,
- Jasmine McIntosh,
- Bradley D. Lloyd, RRT-ACCS,
- Tiffany L. Israel, MSSW,
- Li Wang, MS,
- Todd W. Rice, MD,
- Wesley H. Self, MD MPH,
- Jin H. Han, MD,
- Jonathan D. Casey, MD,
- Matthew W. Semler, MD
Affiliations
- Stephanie C. DeMasi, MD
- Department of Emergency Medicine, Nashville, TN
- Brant Imhoff, MS
- Department of Biostatistics, Nashville, TN
- Ariel A. Lewis, BSN, RN, MPH
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN
- Kevin P. Seitz, MD
- Division of Allergy, Pulmonary, and Critical Care Medicine, Nashville, TN
- Brian E. Driver, MD
- Department of Emergency Medicine, Minneapolis, MN
- Kevin W. Gibbs, MD
- Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Department of Medicine, Winston-Salem, NC
- Adit A. Ginde, MD, MPH
- Department of Emergency Medicine, Aurora, CO
- Stacy A. Trent, MD, MPH
- Department of Emergency Medicine, Aurora, CO; Department of Emergency Medicine, Denver, CO
- Derek W. Russell, MD
- Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, Birmingham, AL; Pulmonary Section, Birmingham Veteran's Affairs Medical Center, Birmingham, AL
- Amelia L. Muhs, MD
- Division of Allergy, Pulmonary, and Critical Care Medicine, Nashville, TN
- Matthew E. Prekker, MD, MPH
- Department of Emergency Medicine, Minneapolis, MN; Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Hennepin County Medical Center, Minneapolis, MN
- John P. Gaillard, MD
- Department of Anesthesiology-Critical Care, Winston-Salem, NC; Department of Emergency Medicine, Wake Forest School of Medicine, Winston-Salem, NC
- Daniel Resnick-Ault, MD
- Department of Emergency Medicine, Aurora, CO
- L. Jane Stewart, MD, JD, MPH
- Department of Anesthesiology, University of Colorado School of Medicine, Aurora, CO; Department of Anesthesiology, Denver Health Medical Center, Denver, CO
- Micah R. Whitson, MD
- Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, Birmingham, AL; Department of Emergency Medicine, University of Alabama at Birmingham, Birmingham, AL
- Graham W.W. Van Schaik, MD, MBA
- Department of Emergency Medicine, Nashville, TN
- Aaron E. Robinson, MD, MPH
- Department of Emergency Medicine, Minneapolis, MN
- Jessica A. Palakshappa, MD
- Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Department of Medicine, Winston-Salem, NC
- Neil R. Aggarwal, MD, MHSc
- Division of Pulmonary Sciences and Critical Care Medicine, Department of Medicine, University of Colorado Anschutz Medical Center, Aurora, CO
- Jason C. Brainard, MD
- Department of Anesthesiology, University of Colorado School of Medicine, Aurora, CO
- David J. Douin, MD
- Department of Anesthesiology, University of Colorado School of Medicine, Aurora, CO
- Carolynn Lyle, PA-C, MPH
- Department of Emergency Medicine, Denver, CO
- Sheetal Gandotra, MD
- Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, Birmingham, AL
- Aaron J. Lacy, MD
- Department of Emergency Medicine, Nashville, TN
- Kristen C. Sherlin, PharmD
- Department of Pharmacy, Vanderbilt University Medical Center, Nashville, TN
- Greta K. Carlson, MD
- Department of Emergency Medicine, Minneapolis, MN; Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Hennepin County Medical Center, Minneapolis, MN
- J. Maycee Cain, BS
- Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Department of Medicine, Winston-Salem, NC
- Brianne Redman, MD
- Department of Emergency Medicine, Wake Forest School of Medicine, Winston-Salem, NC
- Carrie Higgins, BSN
- Division of Pulmonary Sciences and Critical Care Medicine, Department of Medicine, University of Colorado Anschutz Medical Center, Aurora, CO
- Cori Withers, BS
- Department of Emergency Medicine, Aurora, CO
- Logan L. Beach, MD
- Department of Emergency Medicine, University of Alabama at Birmingham, Birmingham, AL
- Barbara Gould
- Denver Health Medical Center, Denver, CO
- Jasmine McIntosh
- Birmingham Veteran’s Affairs Medical Center, Birmingham, AL
- Bradley D. Lloyd, RRT-ACCS
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN
- Tiffany L. Israel, MSSW
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN
- Li Wang, MS
- Department of Biostatistics, Nashville, TN
- Todd W. Rice, MD
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN; Division of Allergy, Pulmonary, and Critical Care Medicine, Nashville, TN
- Wesley H. Self, MD MPH
- Department of Emergency Medicine, Nashville, TN; Vanderbilt Institute for Clinical and Translational Research, Nashville, TN
- Jin H. Han, MD
- Department of Emergency Medicine, Nashville, TN; Geriatric Research, Education, and Clinical Center, Tennessee Valley Healthcare System, Nashville, TN
- Jonathan D. Casey, MD
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN; Division of Allergy, Pulmonary, and Critical Care Medicine, Nashville, TN
- Matthew W. Semler, MD
- Vanderbilt Institute for Clinical and Translational Research, Nashville, TN; Division of Allergy, Pulmonary, and Critical Care Medicine, Nashville, TN; CORRESPONDENCE TO: Matthew W. Semler, MD
- DOI
- https://doi.org/10.1016/j.chstcc.2025.100177
- Journal volume & issue
-
Vol. 3,
no. 3
p. 100177
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
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