drugset / Trial / NCT05277896
Randomized Trial of Sedative Choice for Intubation
Phase 4
Completed
2367 enrolled
Vanderbilt University Medical Center
National Heart, Lung, and Blood Institute (NHLBI) · collabPatient-Centered Outcomes Research Institute · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Among critically ill adults undergoing emergency tracheal intubation, one in five experience hypotension, cardiac arrest, or death. The sedatives used to rapidly induce anesthesia for emergency tracheal intubation have been hypothesized to effect cardiovascular complications and patient outcomes, but the optimal sedative medication for intubation of critically ill adults remains unknown. Ketamine and etomidate are the two most commonly used sedatives during intubation of critically ill adults. Data from a randomized clinical trial are urgently needed to determine the effect of ketamine versus etomidate on cardiovascular complications and clinical outcomes of emergency tracheal intubation.
Timeline
- Start
- 2022-04-06
- Primary completion
- 2025-09-06
- Completion
- 2025-09-06
Publications
- Lewis AA, Israel TL, Seitz KP, Driver BE, Gibbs KW, Ginde AA, Trent SA, Russell DW, Prekker ME, Robinson AE, Palakshappa JA, Gaillard JP, Stewart LJ, Beach LL, Lloyd BD, DeMasi SC, Hays MA, Withers C, Sullivan AE, Lyle C, Whitson MR, Gould B, Rice TW, Self WH, Han JH, Semler MW, Casey JD; RSI investigators and the Pragmatic Critical Care Research Group. Community consultation and public disclosure for the Randomized Trial of Sedative Choice for Intubation. Trials. 2026 Apr 10;27(1):368. doi: 10.1186/s13063-026-09665-9.
- DeMasi SC, Imhoff B, Lewis AA, Seitz KP, Driver BE, Gibbs KW, Ginde AA, Trent SA, Russell DW, Muhs AL, Prekker ME, Gaillard JP, Resnick-Ault D, Stewart LJ, Whitson MR, Van Schaik GWW, Robinson AE, Palakshappa JA, Aggarwal NR, Brainard JC, Douin DJ, Lyle C, Gandotra S, Lacy AJ, Sherlin KC, Carlson GK, Maycee Cain J, Redman B, Higgins C, Withers C, Beach LL, Gould B, McIntosh J, Lloyd BD, Israel TL, Wang L, Rice TW, Self WH, Han JH, Casey JD, Semler MW. Protocol and Statistical Analysis Plan for a Multicenter Randomized Trial of Ketamine vs Etomidate for Emergency Tracheal Intubation. CHEST Crit Care. 2025 Sep;3(3):100177. doi: 10.1016/j.chstcc.2025.100177. Epub 2025 Aug 13.
- Casey JD, Seitz KP, Driver BE, Gibbs KW, Ginde AA, Trent SA, Russell DW, Muhs AL, Prekker ME, Gaillard JP, Resnick-Ault D, Stewart LJ, Whitson MR, DeMasi SC, Robinson AE, Palakshappa JA, Aggarwal NR, Brainard JC, Douin DJ, Marvi TK, Scott BK, Alber SM, Lyle C, Gandotra S, Van Schaik GW, Lacy AJ, Sherlin KC, Erickson HL, Cain JM, Redman B, Beach LL, Gould B, McIntosh J, Lewis AA, Lloyd BD, Israel TL, Imhoff B, Wang L, Spicer AB, Churpek MM, Rice TW, Self WH, Han JH, Semler MW; RSI Investigators and the Pragmatic Critical Care Research Group. Ketamine or Etomidate for Tracheal Intubation of Critically Ill Adults. N Engl J Med. 2026 Apr 23;394(16):1608-1620. doi: 10.1056/NEJMoa2511420. Epub 2025 Dec 9.
- DeMasi SC, Imhoff B, Lewis AA, Seitz KP, Driver BE, Gibbs KW, Ginde AA, Trent SA, Russell DW, Muhs AL, Prekker ME, Gaillard JP, Resnick-Ault D, Stewart LJ, Whitson MR, Van Schaik GWW, Robinson AE, Palakshappa JA, Aggarwal NR, Brainard JC, Douin DJ, Lyle C, Gandotra S, Lacy AJ, Sherlin KC, Carlson GK, Cain JM, Redman B, Higgins C, Withers C, Beach LL, Gould B, McIntosh J, Lloyd BD, Israel TL, Wang L, Rice TW, Self WH, Han JH, Casey JD, Semler MW; RSI investigators and the Pragmatic Critical Care Research Group. Protocol and Statistical Analysis Plan for the Randomized Trial of Sedative Choice for Intubation (RSI). medRxiv [Preprint]. 2025 Jan 18:2025.01.18.25320768. doi: 10.1101/2025.01.18.25320768.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Etomidate | Small molecule | 0.3 mg/kg | Intravenous |
| Comparator | Ketamine | Small molecule | 2 mg/kg | Intravenous |