Randomized Trial of Sedative Choice for Intubation
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.
Conditions:
🦠 Acute Respiratory Failure
🗓️ Study Start (Actual) 6 April 2022
🗓️ Primary Completion (Estimated) 1 January 2027
✅ Study Completion (Estimated) 1 February 2027
👥 Enrollment (Estimated) 2364
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Birmingham, Alabama, United States
📍 Aurora, Colorado, United States
📍 Denver, Colorado, United States
📍 Minneapolis, Minnesota, United States
📍 Winston-Salem, North Carolina, United States
📍 Nashville, Tennessee, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 3 March 2022
  • First Submitted that Met QC Criteria 3 March 2022
  • First Posted 14 March 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 12 July 2024
  • Last Update Posted 16 July 2024
  • Last Verified July 2024