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

Ketamine

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.

Intervention / Treatment

  • Etomidate (DRUG)
    Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.
  • Ketamine (DRUG)
    Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation.
  • Emergency Endotracheal Intubation (PROCEDURE)
    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.
  • Mechanical Ventilation (DEVICE)
    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.

Condition or Disease

  • Cardiopulmonary Arrest
  • Respiratory Arrest

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 801 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

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    Clinical Trial Dates

    Start date: Jun 06, 2016 ACTUAL
    Primary Completion: Dec 01, 2020 ACTUAL
    Completion Date: Dec 01, 2020 ACTUAL
    Study First Posted: Dec 31, 2015 ESTIMATED
    Results First Posted: Dec 15, 2021 ACTUAL
    Last Updated: Nov 15, 2021

    Sponsors / Collaborators

    Lead Sponsor: University of Texas Southwestern Medical Center
    Responsible Party: N/A

    Location

    Dallas, Texas, USA

    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).

    Participant Groups

    • Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.

    • Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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.

    Primary Outcomes

    • Survival is defined as the number of participants survived at day 7 following emergency endotracheal intubation

    Secondary Outcomes

    • Survival is defined as the number of participants survived at day 28 following emergency endotracheal intubation

    • 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

    • Duration (in days) from insertion to removal of mechanical ventilation

    • Time (in days) from start to end of catecholamine therapy

    • Length (in days) of ICU stay

    • New diagnosis of adrenal insufficiency will be assessed by the the primary treating medical or surgical team via chart review

    • This referrers to the number of documented intubation attempts necessary to intubate the patient.

    More Details

    NCT Number: NCT02643381
    Acronym: EvK
    Other IDs: 022015-023
    Study URL: https://clinicaltrials.gov/study/NCT02643381
    Last updated: Sep 29, 2023