An observational study in Post-Traumatic Stress Disorder and Acute Respiratory Failure, sponsored by Vanderbilt University Medical Center. Enrolling by invitation at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Vanderbilt University Medical Center · Observational
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.
2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 554 are open to participants now.
This study's planned enrollment of 1,756 is above the median of 136 across 295 observational studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
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Critically ill adults undergoing emergency tracheal intubation who were enrolled in the RSI trial (NCT05277896) and meet eligibility criteria for long-term outcomes assessment.
Exclusion Criteria:
Intravenous ketamine as the sedative for induction of anesthesia during emergency tracheal intubation.
Drug: Ketamine
Intravenous etomidate as the sedative for induction of anesthesia during emergency tracheal intubation.
Drug: Etomidate
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.
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.
PTSD Symptoms at 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).
Time frame: 12 months
Vital status
Date and location of death will be assessed from enrollment until 12 months after enrollment by trial personnel using review of electronic health records, phone calls with families, and national death indices.
Time frame: 12 months
Awareness of paralysis
This will be determined by the modified Brice questionnaire and ICU Memory Tool (15-20 minutes). These semi-structured interviews ask subjects about their recollection of the ICU experience, including of being paralyzed. Possible awareness with paralysis event (Present/Absent) will be defined as: (1)reporting memories of the period between losing consciousness and waking up and (2) a sensation/feeling of wakeful paralysis.
Time frame: 3 months
ICU Memories
This will be determined by the ICU Memory Tool (15-20 minutes). These semi-structured interviews ask subjects about their recollection of the ICU experience, including emotions, memories, and the worst thing experienced during mechanical ventilation. Patients will be classified as having (1) factual memories, (2) delusional memories, (3) memories of feelings. These choices are not mutually exclusive as they may have more than one or none of these memories.
Time frame: 3 months
Threat perception
This 7-item questionnaire assesses the patient's perception of feeling threatened during the intubation experience. Scores range from 0 (none at all) to 21 (extremely threatened).
Time frame: 3 months
Anxiety
Anxiety symptoms will be characterized using the General Anxiety Disorder-7 (GAD-7) which is a 7-item questionnaire that ranges from 0 (no anxiety) to 21 (severe anxiety).
Time frame: 12 months
Depression
Depression symptoms will be characterized using the Patient Health Questionnaire-9 (PHQ-9) which is a 9-item questionnaire that ranges from 0 (no depression) to 27 (severe depression).
Time frame: 12 months
Quality of life (EQ-5D-5L)
Quality of life will be characterized using the EuroQol 5-Dimension, 5 level version (EQ-5D-5L) is a 5-question instrument that captures impairments in mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. EQ-5D-5L scores will be summarized using the index value validated for the US population. Index scores range range from -0.573 (quality of life worse than death) to 1.000 (perfect quality of life).
Time frame: 12 months
Global Cognition
Global cognition will be characterized using the Montreal Cognitive Assessment - Blind (MoCA-Blind). The MoCA-Blind assesses memory, attention, language, abstraction, delayed recall, and orientation. Scores range from 0 (severe cognitive impairment) to 22 (no cognitive impairment).
Time frame: 12 months
Executive Function
Oral Trailmaking Test - Patient counts from 1 to 25 and then alternates between numbers and letters (i.e., 1-A-2-B-3-C, etc.,)
Time frame: 12 months
Loss of Employment
Patients are asked what their employment status is prior to the acute illness and at 12-months. Patients will be considered to be have loss of employment if they go from: (1) full to partial employment, (2) full to no employment, or (3) partial to no employment.
Time frame: 12 months
Physical disability
Duke Activity Status Index (DASI) - An 11-item survey that assesses the patient's current ability to perform various physical activities. Scores range from 0 (poor physical function) to 58.2 (excellent physical function).
Time frame: 12 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Following publication, individual patient data will be made available for sharing to researchers with 1) a signed data access agreement, 2) research testing a hypothesis, 3) a protocol that has been approved by an institutional review board, and 4) a proposal that has received approval from the principal investigator.
Supporting information: Study protocol, Sap, Icf
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