Clinical trial NCT06179485: Effect of Ketamine and Etomidate During RSI on Long Term Outcomes
Official title: Effect of Ketamine and Etomidate During Rapid Sequence Intubation on Long- Term Outcomes (Long-Term Outcomes of the RSI Trial)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post-Traumatic Stress Disorder
Acute Respiratory Failure
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2023-12-22
Enrollment: 1756
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: PTSD Symptoms at 12 months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: Vital status
timeFrame: 12 months
measure: Awareness of paralysis
timeFrame: 3 months
measure: ICU Memories
timeFrame: 3 months
measure: Threat perception
timeFrame: 3 months
measure: Anxiety
timeFrame: 12 months
measure: Depression
timeFrame: 12 months
measure: Quality of life (EQ-5D-5L)
timeFrame: 12 months
measure: Global Cognition
timeFrame: 12 months
measure: Executive Function
timeFrame: 12 months
measure: Loss of Employment
timeFrame: 12 months
measure: Physical disability
timeFrame: 12 months
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References: