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

Vanderbilt University Medical Center

Status: Enrolling

Conditions: Post-Traumatic Stress Disorder; Acute Respiratory Failure

Treatments: Drug: Etomidate; Drug: Ketamine

Study type: Observational

Funder types: Other

Identifiers

NCT06179485

210500-2

BPS-2022C3-30021 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 1,756 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,756 participants in 2 patient groups

Comparator: Ketamine Group

Description:

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

Treatment:

Drug: Ketamine

Comparator: Etomidate Group

Description:

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

Treatment:

Drug: Etomidate