Etomidate Versus Ketamine for Emergency Endotracheal Intubation: a Prospective Randomized Clinical Trial (EvK)

November 15, 2021 updated by: Gerald Matchett, University of Texas Southwestern Medical Center
Patients who are having problems breathing sometimes require placement of a breathing tube in their mouth and windpipe. The purpose of this breathing tube is to save the patient's life. It is common to give the patient a medication to sedate him or her before the breathing tube is placed. For patients who are gravely ill two medications are commonly used: etomidate or ketamine. Both medications have risks and benefits. Researchers at UT-Southwestern Medical Center and Parkland Memorial Hospital would like to do a study to figure out which one is better for our patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Critically ill individuals who require emergency endotracheal intubation (placement of a breathing tube in the patient's mouth) usually require sedation or anesthesia to make this process tolerable. There are several medication choices for anesthesia, including medications like etomidate, ketamine and propofol. Of these, etomidate and ketamine are frequently used for critically ill patients because they have minimal effects on the patient's vital signs (blood pressure and heart rate). Both etomidate and ketamine are standard-of-care medications, locally and nationally, and both are frequently used to sedate a patient for this procedure. Both etomidate and ketamine have potential side effects. One of the potential side effects of etomidate is suppression of adrenal gland function. It is not known if this affects patients' outcomes in significant ways. One of the potential side effects of ketamine is a slight increase in patients' heart rates. It is not known if this affects patients' outcomes in significant ways.

The EvK Trial will be conducted at Parkland Memorial Hospital by investigators in the Departments of Anesthesiology, Emergency Medicine, Medicine / Critical Care Medicine, Surgery, and Pharmacy. The study will randomize critically ill patients who require emergency endotracheal intubation to one of two groups: Etomidate or Ketamine. We will observe the patients' outcomes. The only study intervention involves randomizing individual patients to one medication or the other. All study follow-up beyond that point is done by review of medical records.

Because of the nature of this study - an emergency procedure on a critically ill patient - the study will require institutional review board permission not to obtain written informed consent from the patient prior to randomization of study drug for administration for endotracheal tube placement. Prior to enrollment of patients the study team will carry out a comprehensive Community Consultation Plan, which is designed to inform the community about the research study. This is in accordance with rules set forth by the U.S. Food and Drug Administration (FDA 21 CFR 50.24).

Study Type

Interventional

Enrollment (Actual)

801

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75235
        • Parkland Hospital

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.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patient (male or female) requiring emergency endotracheal intubation.

Exclusion Criteria:

  • Children (<18 years old).
  • Women who are known to be pregnant.
  • Any patient who has been previously randomized in the EvK Trial.
  • Patients who require endotracheal intubation without sedative medication. For example, patients in full cardiac arrest.
  • Patients with a known allergy to ketamine or etomidate.
  • Any individual wearing a MedAlert bracelet indicating that he/she has formally opted out of the EvK Trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Etomidate
Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.
Drug: Etomidate
Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.
Procedure: Emergency Endotracheal Intubation
Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes.
Device: Mechanical Ventilation
Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.
Experimental: Ketamine
Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation.
Procedure: Emergency Endotracheal Intubation
Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes.
Device: Mechanical Ventilation
Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.
Drug: Ketamine
Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival at Day 7
Time Frame: Day 7
Survival is defined as the number of participants survived at day 7 following emergency endotracheal intubation
Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival at Day 28
Time Frame: Day 28
Survival is defined as the number of participants survived at day 28 following emergency endotracheal intubation
Day 28
Sequential Organ Failure Assessment (SOFA) Scores
Time Frame: Day 1, Day 2, Day 3, Day 4
Sequential Organ Failure Assessment (SOFA) is a scoring system that assesses the performance of several organ systems. Possible scores range from 0 to 24. Higher score indicates higher degree of organ dysfunction
Day 1, Day 2, Day 3, Day 4
Duration of Mechanical Ventilation
Time Frame: From time of documented insertion until the time of documented removal, assessed up to 28 days
Duration (in days) from insertion to removal of mechanical ventilation
From time of documented insertion until the time of documented removal, assessed up to 28 days
Duration of Catecholamine Therapy
Time Frame: From time of documented start of therapy until the time of documented end of therapy, assessed up to 28 days
Time (in days) from start to end of catecholamine therapy
From time of documented start of therapy until the time of documented end of therapy, assessed up to 28 days
Length of Stay in ICU
Time Frame: Assessed up to 28 days
Length (in days) of ICU stay
Assessed up to 28 days
Number of Participants With New Diagnosis of Adrenal Insufficiency
Time Frame: Day 28
New diagnosis of adrenal insufficiency will be assessed by the the primary treating medical or surgical team via chart review
Day 28
Number of Attempts Necessary to Intubate
Time Frame: Immediate (Day 1)
This referrers to the number of documented intubation attempts necessary to intubate the patient.
Immediate (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Gerald Matchett, MD, University of Texas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

June 6, 2016

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

December 11, 2015

First Submitted That Met QC Criteria

December 29, 2015

First Posted (Estimate)

December 31, 2015

Study Record Updates

Last Update Posted (Actual)

December 15, 2021

Last Update Submitted That Met QC Criteria

November 15, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 022015-023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Aggregate anonymous data will be published in accord with our IRB approval.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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