COMPLETED

Randomized Trial of Sedative Choice for Intubation

Conditions

Acute Respiratory Failure Critical illness Emergency airway management Tracheal intubation Ketamine Etomidate

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Among critically ill adults undergoing emergency tracheal intubation, one in five experience hypotension, cardiac arrest, or death. The sedatives used to rapidly induce anesthesia for emergency tracheal intubation have been hypothesized to effect cardiovascular complications and patient outcomes, but the optimal sedative medication for intubation of critically ill adults remains unknown. Ketamine and etomidate are the two most commonly used sedatives during intubation of critically ill adults. Data from a randomized clinical trial are urgently needed to determine the effect of ketamine versus etomidate on cardiovascular complications and clinical outcomes of emergency tracheal intubation.

Official Title

The Randomized Trial of Sedative Choice for Intubation

Quick Facts

Study Start:2022-04-06

Study Completion:2025-09-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05277896

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

UAB Hospital

Birmingham, Alabama, 35233

United States

University of Colorado Denver

Aurora, Colorado, 80045

United States

Denver Health Medical Center

Denver, Colorado, 80204

United States

Hennepin County Medical Center

Minneapolis, Minnesota, 55415

United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-06

Study Completion Date2025-09-06

Study Record Updates

Study Start Date2022-04-06

Study Completion Date2025-09-06

Terms related to this study

Keywords Provided by Researchers

Critical illness
Emergency airway management
Tracheal intubation
Ketamine
Etomidate

Additional Relevant MeSH Terms

Acute Respiratory Failure