Effect of Ketamine and Etomidate During RSI on Long Term Outcomes

NCT ID: NCT06179485

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 1756 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-06
• Study Completion Date: 2028-03-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Comparator: Ketamine Group

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

Ketamine

Intervention Type: 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: Etomidate Group

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

Etomidate

Intervention Type: 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.

Interventions

Ketamine

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.

Intervention Type: DRUG

Etomidate

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Enrolled in RSI trial (NCT05277896)

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Casey

Assistant Professor of Medicine, Department of Medicine, Allergy, Pulmonary and Critical Care Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

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

Countries

United States

Other Identifiers

BPS-2022C3-30021

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

210500-2

Identifier Type: -

Identifier Source: org_study_id