Phase 4
Completed N=2,367
Randomized Trial of Sedative Choice for Intubation
Source: ClinicalTrials.gov NCT05277896 ↗Enrolled (actual)
2,367
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcomePrimary: All-cause, 28-day, In-hospital Mortality — 330; 345 Participants
◆ Published Evidence
Established
▲ Trending
27citations · ~27 / year
Ketamine or Etomidate for Tracheal Intubation of Critically Ill Adults.
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.
Linked Publications (4)
-
Ketamine or Etomidate for Tracheal Intubation of Critically Ill Adults.
-
Protocol and Statistical Analysis Plan for a Multicenter Randomized Trial of Ketamine vs Etomidate for Emergency Tracheal Intubation.
-
Community consultation and public disclosure for the Randomized Trial of Sedative Choice for Intubation.
-
Protocol and Statistical Analysis Plan for the Randomized Trial of Sedative Choice for Intubation (RSI).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause, 28-day, In-hospital Mortality |
330; 345 | — |
| SECONDARY Cardiovascular Collapse |
260; 202; 73; 64; 251; 189 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is critically ill and undergoing emergency tracheal intubation with sedation in an enrolling unit
- Planned procedure is orotracheal intubation using a laryngoscope
- Planned operator is a clinician expected to routinely perform tracheal intubation in the participating unit
Exclusion Criteria
- Patient is known to be less than 18 years old
- Patient is known to be pregnant
- Patient is known to be a prisoner
- Patient is known to have an allergy to ketamine or etomidate
- Patient is presenting to the emergency department with a primary diagnosis of trauma
- Patient or LAR declines participation during pre-enrollment opt-out conversation or by wearing opt-out bracelet for the RSI trial
- Clinician feels ketamine is required or contraindicated for the optimal care of the patient
- Clinician feels etomidate is required or contraindicated for the optimal care of the patient
- Clinician feels an induction medication other than ketamine or etomidate is required for the optimal care of the patient
- Immediate need for intubation precludes safe performance of study procedures
Data sourced from ClinicalTrials.gov (NCT05277896) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.