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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.
This trial investigates if ketamine reduces mortality in emergency tracheal intubation compared to etomidate. Results will inform critical care sedation practices for intubated patients.
Area of Science:
- Critical Care Medicine
- Anesthesiology
- Emergency Medicine
Background:
- Emergency tracheal intubation is a high-risk procedure with uncertain effects of induction medications.
- Ketamine and etomidate are commonly used sedatives for this procedure.
Purpose of the Study:
- To determine if ketamine decreases 28-day mortality in critically ill adults undergoing emergency tracheal intubation compared to etomidate.
- To assess the incidence of cardiovascular collapse during intubation as a secondary outcome.
Main Methods:
- The Randomized Trial of Sedative Choice for Intubation (RSI) is a pragmatic, multicenter, randomized trial.
- Comparing ketamine versus etomidate in 2,364 critically ill adults undergoing emergency tracheal intubation.
- Primary outcome: all-cause 28-day in-hospital mortality. Secondary outcome: cardiovascular collapse.
Main Results:
- Enrollment initiated April 2022, with completion anticipated in 2025.
- Data on mortality and cardiovascular collapse are pending final results.
Conclusions:
- The RSI trial will yield crucial data on ketamine versus etomidate for emergency tracheal intubation.
- Protocol and analysis plan transparency enhance trial rigor and reproducibility.
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