Randomized Trial of Sedative Choice for Intubation (NCT05277896) | Clinical Trial Compass
CompletedPhase 4
Randomized Trial of Sedative Choice for Intubation
United States2,367 participantsStarted 2022-04-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.