Effect of Ketamine and Etomidate During RSI on Long Term Outcomes

NCT06179485 | Enrolling By Invitation DMC FDA Drug

• 2 other identifiers: 210500-2BPS-2022C3-30021
• Study Type: observational
• Target: 1,756
• Locations: 1 country
• Sites: 6

Brief Summary

The RSI-LTO study collects long-term outcomes from the RSI trial (NCT05277896). One-third of adults who are intubated in the ED or ICU experience symptoms of posttraumatic stress disorder (PTSD). PTSD is a psychiatric disorder triggered by a "shocking, scary, or dangerous event." Critical illness, tracheal intubation, and mechanical ventilation can be traumatic and distressing events. Patients may recall the intubation procedure, the feeling of the breathing tube in their throat, or being unable to move ("paralyzed"). While on the breathing machine, patients may experience delirium, frightening hallucinations, and delusions. Patients with PTSD after critical illness can be hypervigilant, anxious, and troubled by intrusive thoughts, nightmares, and flashbacks that last months to years after critical illness and that PTSD negatively impacts patients' marriages, work, and quality of life and increases patients' risk of depression, anxiety, substance use disorder, and suicide. Ketamine may prevent PTSD symptoms by blocking the pathways in the brain's glutaminergic system that are responsible for the formation of traumatic memories In outpatients with chronic PTSD, a single dose of ketamine has been shown to reduce PTSD symptoms for up to 2 weeks. Even a modest reduction in PTSD would translate into tens of thousands of fewer cases of PTSD each year, more cases of PTSD each year than any other medical intervention evaluated to date.

Conditions

Post-Traumatic Stress Disorder; Acute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• PTSD Symptoms at 12 months

  The investigators will measure PTSD symptoms at 3 and 12 months using the Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5). The PCL-5 is a widely used 5-10 minute patient survey validated to characterize severity of symptoms of PTSD. Patients rate 20 items corresponding to the DSM-5 criteria for PTSD on a 5-point Likert scale ranging from 0 (not bothersome) to 4 (extremely bothersome). Total scores range from 0 to 80, with higher scores indicating more severe symptoms of PTSD. Because a value for the PCL-5 score will not exist for patients who die prior to assessment, the main analysis will use a composite endpoint approach where patients whose PCL-5 could not be assessed because they died will be assigned a value of 81 (higher than the worst value on the PTSD symptom scale).

  12 months

Other Outcomes (11)

• Vital status

  12 months

• Awareness of paralysis

  3 months

• ICU Memories

  3 months

Study Arms (2)

Comparator: Ketamine Group

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

Drug: Ketamine

Comparator: Etomidate Group

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

Drug: Etomidate

Interventions

Ketamine DRUG

The RSI-LTO study collects long-term outcomes from the RSI trial (NCT05277896). In the RSI trial, patients in the ketamine group will be assigned to receive intravenous ketamine for induction of anesthesia during tracheal intubation. A dose of 2 mg/kg will be recommended, and the group assignment sheet will contain a nomogram providing the recommended dose for a range of patient weights (in pounds and kg). Treating clinicians will be able elect to give a lesser or greater dose of ketamine than recommended if felt to be required for optimal patient care.

Comparator: Ketamine Group

Etomidate DRUG

The RSI-LTO study collects long-term outcomes from the RSI trial (NCT05277896). In the RSI trial, patients in the etomidate group will be assigned to receive intravenous etomidate for induction of anesthesia during tracheal intubation. A dose of 0.3 mg/kg will be recommended, and the group assignment sheet will contain a nomogram providing the recommended dose for a range of patient weights (in pounds and kg). Treating clinicians will be able elect to give a lesser or greater dose of etomidate than recommended if felt to be required for optimal patient care.

Comparator: Etomidate Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill adults undergoing emergency tracheal intubation who were enrolled in the RSI trial (NCT05277896) and meet eligibility criteria for long-term outcomes assessment.

You may qualify if:

• Enrolled in RSI trial (NCT05277896)

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (6)

University of Alabama Hospital

Birmingham, Alabama, 35233, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Ketamine; Etomidate

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Department of Medicine, Allergy, Pulmonary and Critical Care Medicine

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 22, 2023
• Study Start: April 6, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (6)