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

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ClinicalTrials.gov Identifier: NCT02643381
Recruitment Status : Active, not recruiting
First Posted : December 31, 2015
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Gerald Matchett, University of Texas Southwestern Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cardiopulmonary Arrest Respiratory Arrest Drug: Etomidate Drug: Ketamine Procedure: Emergency Endotracheal Intubation Device: Mechanical Ventilation Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 825 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Etomidate Versus Ketamine for Emergency Endotracheal Intubation: a Prospective Randomized Clinical Trial
Actual Study Start Date : June 6, 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Survival [ Time Frame: Day 7 ]
    Survival at day 7 following emergency endotracheal intubation.


Secondary Outcome Measures :
  1. Survival [ Time Frame: Day 28 ]
    Survival at day 28 following emergency endotracheal intubation.

  2. Sequential Organ Failure Assessment (SOFA) scores [ Time Frame: Day 0-28 ]
    SOFA scores following emergency endotracheal intubation.

  3. Immediate outcomes of endotracheal intubation. [ Time Frame: Day 0 ]
    Each intubation will be assessed for specific immediate outcomes including the following: Number of attempts required to successfully intubate the patient and the presence or absence of specific traumatic complications that are known risks of the procedure including oral / dental trauma, bleeding, and/or aspiration.

  4. Duration of mechanical ventilation. [ Time Frame: Day 0-28 ]
    Duration of mechanical ventilation.

  5. Duration of catecholamine therapy [ Time Frame: Day 0-28 ]
    Duration of catecholamine therapy

  6. Length of stay in ICU / hospital [ Time Frame: Day 0-28 ]
    Length of stay in ICU / hospital

  7. New diagnosis of adrenal insufficiency [ Time Frame: Day 0-28 ]
    Specific testing for adrenal insufficiency will not be performed as part of the study. However, the charts of all patients enrolled in the study will be assessed to see if the primary treating medical or surgical team has made a diagnosis of adrenal insufficiency. The total number of subjects with this new diagnosis will be recorded.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643381


Locations
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United States, Texas
Parkland Hospital
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Gerald Matchett, MD University of Texas
  Study Documents (Full-Text)

Documents provided by Gerald Matchett, University of Texas Southwestern Medical Center:
Statistical Analysis Plan  [PDF] August 25, 2020

More Information
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Publications of Results:

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Responsible Party: Gerald Matchett, Associate Professor of Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02643381    
Other Study ID Numbers: 022015-023
First Posted: December 31, 2015    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Aggregate anonymous data will be published in accord with our IRB approval.
Keywords provided by Gerald Matchett, University of Texas Southwestern Medical Center:
etomidate
ketamine
endotracheal intubation
anesthesia induction medications
Additional relevant MeSH terms:
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Apnea
Heart Arrest
Emergencies
Disease Attributes
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Ketamine
Etomidate
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives