Effect of Ketamine and Etomidate During RSI on Long Term Outcomes

Recruiting

• Conditions: Acute Respiratory Failure; Post-Traumatic Stress Disorder
• Interventions: Drug: Ketamine; Drug: Etomidate

• Registration Number: NCT06179485
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-06
• Study First Submitted: 2023-12-08
• Study First Submitted QC: 2023-12-19
• Study First Posted: 2023-12-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08
• Primary Completion: 2027-01
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1756

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Comparator: Ketamine Group	Ketamine	Intravenous ketamine as the sedative for induction of anesthesia during emergency tracheal intubation.
Comparator: Etomidate Group	Etomidate	Intravenous etomidate as the sedative for induction of anesthesia during emergency tracheal intubation.

Primary Outcome Measures

Name	Time	Method
PTSD Symptoms at 12 months	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).

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States