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Protocol and Statistical Analysis Plan for a Multicenter Randomized Trial of Ketamine vs Etomidate for Emergency
Stephanie C DeMasi1, Brant Imhoff1, Ariel A Lewis1
1From the Department of Emergency Medicine (S. C. D., G. W. W. V. S., A. J. L., W. H. S., and J. H. H.), the Department of Biostatistics (B. I. and L. W.), the Vanderbilt Institute for Clinical and Translational Research (A. A. L., B. D. L., T. L. I., T. W. R., W. H. S., J. D. C., and M. W. S.), the Division of Allergy, Pulmonary, and Critical Care Medicine (K.P. S., A. L. M., T. W. R., J. D. C., and M. W. S.), the Department of Pharmacy (K. C. S.), Vanderbilt University Medical Center, the Geriatric Research, Education, and Clinical Center (J. H. H.), Tennessee Valley Healthcare System, Nashville, TN; the Department of Emergency Medicine (B. E. D., M. E.P., A. E. R., and G. K. C.), the Division of Pulmonary, Allergy, and Critical Care Medicine (M. E.P. and G. K. C.), Department of Medicine, Hennepin County Medical Center, Minneapolis, MN; the Section of Pulmonary, Critical Care, Allergy and Immunologic Disease (K. W. G., J. A.P., and J. M. C.), Department of Medicine, the Department of Anesthesiology-Critical Care (J.P. G.), the Department of Emergency Medicine (J.P. G. and B. R.), Wake Forest School of Medicine, Winston-Salem, NC; the Department of Emergency Medicine (A. A. G., S. A. T., D. R.-A., and C. W.), the Department of Anesthesiology (L. J. S., J. C. B., and D. J. D.), University of Colorado School of Medicine; the Division of Pulmonary Sciences and Critical Care Medicine (N. R. A. and C. H.), Department of Medicine, University of Colorado Anschutz Medical Center, Aurora; the Department of Emergency Medicine (S. A. T. and C. L.), the Department of Anesthesiology (L. J. S.), Denver Health Medical Center (B. G.), Denver, CO; the Division of Pulmonary, Allergy and Critical Care Medicine (D. W. R., M. R. W., and S. G.), Department of Medicine, the Department of Emergency Medicine (M. R. W. and L. L. B.), University of Alabama at Birmingham, the Pulmonary Section (D. W. R.), Birmingham Veteran's Affairs Medical Center (J. M.), Birmingham, AL.
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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