Clinical TrialPTSDKetaminePlaceboEnrolling by invitation

Effect of Ketamine and Etomidate During RSI on Long Term Outcomes (RSI-LTO)

This observational cohort study (n=1756) aims to collect long-term outcomes from the RSI trial (NCT05277896). It was conducted by Vanderbilt University Medical Center and led by Jonathan Casey, MD, MSc.

Target Enrollment
1756 participants
Study Type
Phase NA observational
Design
Non-randomized

Detailed Description

The RSI-LTO study is a prospective cohort following critically ill adults enrolled in the RSI trial to measure long-term outcomes including PTSD symptoms after emergency tracheal intubation; the study compares groups assigned to ketamine versus etomidate during induction.

Recommended induction doses in the parent RSI trial were ketamine 2 mg/kg IV and etomidate 0.3 mg/kg IV (nomograms provided); clinicians may adjust dosing. Outcomes assess PTSD, mental health, function, and related sequelae over follow-up.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Ketamine group

experimental

Intravenous ketamine as the sedative for induction of anesthesia during emergency tracheal intubation.

Interventions

  • Ketamine2 mg/kg
    via IV• single dose• 1 doses total

    Recommended dose 2 mg/kg; nomogram provided; clinicians may adjust dose.

Etomidate group

active comparator

Intravenous etomidate as the sedative for induction of anesthesia during emergency tracheal intubation.

Interventions

  • Placebo0.3 mg/kg
    via IV• single dose• 1 doses total

    Etomidate 0.3 mg/kg recommended; nomogram provided; clinicians may adjust dose.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Enrolled in RSI trial (NCT05277896)

Exclusion Criteria

  • Exclusion Criteria:
  • Aphasic or non-verbal prior to tracheal intubation
  • Cannot follow commands prior to tracheal intubation
  • Non-English speaking
  • Deaf

Study Details

  • Status
    Enrolling by invitation
  • Phase
    Phase NA
  • Type
    observational
  • Design
    Non-randomized
  • Target Enrollment1756 participants
  • Timeline
    Start: 2022-04-06
    End: 2028-03-31
  • Compounds
    KetaminePlacebo
  • Topic
    PTSD

Locations

University of Alabama 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

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