Effect of Ketamine and Etomidate During RSI on Long Term Outcomes

Last updated: January 6, 2025
Sponsor: Vanderbilt University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Post-traumatic Stress Disorders

Acute Respiratory Distress Syndrome (Ards)

Treatment

Etomidate

Ketamine

Clinical Study ID

NCT06179485
210500-2
BPS-2022C3-30021
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Enrolled in RSI trial (NCT05277896)

Exclusion

Exclusion Criteria:

  • Aphasic or non-verbal prior to tracheal intubation

  • Cannot follow commands prior to tracheal intubation

  • Non-English speaking

  • Deaf

Study Design

Total Participants: 1756
Treatment Group(s): 2
Primary Treatment: Etomidate
Phase:
Study Start date:
April 06, 2022
Estimated Completion Date:
March 31, 2028

Connect with a study center

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

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