Status:
COMPLETED
Randomized Trial of Sedative Choice for Intubation
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Patient-Centered Outcomes Research Institute
Conditions:
Acute Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 trache...
Detailed Description
Each year more than 1.5 million critically ill adults receive invasive mechanical ventilation in the United States, at a cost of nearly $30 billion dollars annually. Recent research has dramatically i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2025
Estimated Enrollment :
2367 Patients enrolled
Trial Details
Trial ID
NCT05277896
Start Date
April 6 2022
End Date
September 6 2025
Last Update
September 15 2025
Active Locations (6)
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1
UAB Hospital
Birmingham, Alabama, United States, 35233
2
University of Colorado Denver
Aurora, Colorado, United States, 80045
3
Denver Health Medical Center
Denver, Colorado, United States, 80204
4
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415