Effect of Ketamine and Etomidate During RSI on Long Term Outcomes

Post-Traumatic Stress Disorder Clinical Trial

— RSI-LTO  

Official title:

Effect of Ketamine and Etomidate During Rapid Sequence Intubation on Long- Term Outcomes (Long-Term Outcomes of the RSI Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06179485
• Other study ID #: 210500-2
• Secondary ID: BPS-2022C3-30021
• Status: Recruiting
• Start date: April 6, 2022
• Est. completion date: March 2028

Study information

• Verified date: December 2023
• Source: Vanderbilt University Medical Center
• Contact: Jonathan D Casey, MD, MSc
• Phone: 615-208-6139
• Email: jonathan.d.casey[@]vumc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1756
• Est. completion date: March 2028
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Post-Traumatic Stress Disorder
• Respiratory Insufficiency
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Ketamine
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.
• Etomidate
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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	12 months
Other	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.	3 months
Other	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.	3 months
Other	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).	3 months
Other	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).	12 months
Other	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).	12 months
Other	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).	12 months
Other	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).	12 months
Other	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.,)	12 months
Other	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.	12 months
Other	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).	12 months
Primary	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).	12 months