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 , Matthew W. Semler MD
{"title":"氯胺酮与依托咪酯用于紧急气管插管的多中心随机试验方案和统计分析计划","authors":"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 , Matthew W. Semler MD","doi":"10.1016/j.chstcc.2025.100177","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Research Question</h3><div>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?</div></div><div><h3>Study Design and Methods</h3><div>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.</div></div><div><h3>Results</h3><div>Enrollment began on April 6, 2022, and is expected to conclude in 2025.</div></div><div><h3>Interpretation</h3><div>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.</div></div><div><h3>Clinical Trial Registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>; No.: NCT05277896; URL: <span><span>www.clinicaltrials.gov</span><svg><path></path></svg></span></div></div>","PeriodicalId":93934,"journal":{"name":"CHEST critical care","volume":"3 3","pages":"Article 100177"},"PeriodicalIF":0.0000,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Protocol and Statistical Analysis Plan for a Multicenter Randomized Trial of Ketamine vs Etomidate for Emergency Tracheal Intubation\",\"authors\":\"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 , Matthew W. Semler MD\",\"doi\":\"10.1016/j.chstcc.2025.100177\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>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.</div></div><div><h3>Research Question</h3><div>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?</div></div><div><h3>Study Design and Methods</h3><div>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.</div></div><div><h3>Results</h3><div>Enrollment began on April 6, 2022, and is expected to conclude in 2025.</div></div><div><h3>Interpretation</h3><div>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. 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Protocol and Statistical Analysis Plan for a Multicenter Randomized Trial of Ketamine vs Etomidate for Emergency Tracheal Intubation
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.
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