Randomized Trial of Sedative Choice for Intubation
Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Mar 3, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying which sedative medication, ketamine or etomidate, is better for critically ill adults who need emergency tracheal intubation. Tracheal intubation is a procedure where a tube is inserted into the windpipe to help a person breathe. It's important to understand that about one in five patients who undergo this procedure can face serious complications, like drops in blood pressure or even cardiac arrest. The goal of the trial is to see how each sedative affects these risks and overall patient outcomes during intubation.
To be eligible for this trial, patients must be critically ill and require emergency intubation using a laryngoscope, a tool that helps doctors see the throat and windpipe. Patients should be between the ages of 18 and 74, and they cannot be pregnant, under arrest, or have allergies to the medications being tested. If someone joins the study, they can expect to receive either ketamine or etomidate as part of their care, and their health will be closely monitored to assess how well they respond to the sedative used. This trial is currently recruiting participants, and it aims to provide important information that could help improve care for patients needing this urgent procedure.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patient is critically ill and undergoing emergency tracheal intubation with sedation in an enrolling unit
- • Planned procedure is orotracheal intubation using a laryngoscope
- • Planned operator is a clinician expected to routinely perform tracheal intubation in the participating unit
- Exclusion Criteria:
- • Patient is known to be less than 18 years old
- • Patient is known to be pregnant
- • Patient is known to be a prisoner
- • Patient is known to have an allergy to ketamine or etomidate
- • Patient is presenting to the emergency department with a primary diagnosis of trauma
- • Patient or LAR declines participation during pre-enrollment opt-out conversation or by wearing opt-out bracelet for the RSI trial
- • Clinician feels ketamine is required or contraindicated for the optimal care of the patient
- • Clinician feels etomidate is required or contraindicated for the optimal care of the patient
- • Clinician feels an induction medication other than ketamine or etomidate is required for the optimal care of the patient
- • Immediate need for intubation precludes safe performance of study procedures
About Vanderbilt University Medical Center
Vanderbilt University Medical Center (VUMC) is a leading academic medical center located in Nashville, Tennessee, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, VUMC integrates cutting-edge scientific inquiry with patient-centered care, supporting a diverse array of studies aimed at enhancing medical knowledge and improving treatment outcomes. With a robust infrastructure and a multidisciplinary team of experts, VUMC fosters collaboration across various fields, ensuring the highest standards of safety and ethical considerations in its research endeavors. Through its dedication to medical discovery and education, VUMC plays a pivotal role in shaping the future of medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Minneapolis, Minnesota, United States
Nashville, Tennessee, United States
Winston Salem, North Carolina, United States
Denver, Colorado, United States
Aurora, Colorado, United States
Nashville, Tennessee, United States
Birmingham, Alabama, United States
Patients applied
Trial Officials
Jonathan D Casey, MD, MSc
Principal Investigator
Vanderbilt University Medical Center
Matthew W Semler, MD, MSc
Study Chair
Vanderbilt University Medical Center
Todd W Rice, MD, MSc
Study Director
Vanderbilt University Medical Center
Wesley H Self, MD, MPH
Study Director
Vanderbilt University Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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