Randomized Trial of Sedative Choice for Intubation
Completed · Phase 4
Conditions studied: Acute Respiratory Failure
In brief
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.
Key facts
- Study ID
- NCT05277896
- Run by
- Vanderbilt University Medical Center
- People needed
- 2367
- Starts
- 2022-04-06
- Expected to finish
- 2025-09-06
- Last updated by the study team
- 2026-03-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- UAB Hospital — Birmingham, Alabama, United States
- University of Colorado Denver — Aurora, Colorado, United States
- Denver Health Medical Center — Denver, Colorado, United States
- Hennepin County Medical Center — Minneapolis, Minnesota, United States
- Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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