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

Arm | Intervention/treatment |
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Experimental: Etomidate
Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.
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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.
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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. |
- Survival [ Time Frame: Day 7 ]Survival at day 7 following emergency endotracheal intubation.
- Survival [ Time Frame: Day 28 ]Survival at day 28 following emergency endotracheal intubation.
- Sequential Organ Failure Assessment (SOFA) scores [ Time Frame: Day 0-28 ]SOFA scores following emergency endotracheal intubation.
- 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.
- Duration of mechanical ventilation. [ Time Frame: Day 0-28 ]Duration of mechanical ventilation.
- Duration of catecholamine therapy [ Time Frame: Day 0-28 ]Duration of catecholamine therapy
- Length of stay in ICU / hospital [ Time Frame: Day 0-28 ]Length of stay in ICU / hospital
- 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.

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

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
United States, Texas | |
Parkland Hospital | |
Dallas, Texas, United States, 75235 |
Principal Investigator: | Gerald Matchett, MD | University of Texas |
Documents provided by Gerald Matchett, University of Texas Southwestern Medical Center:
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. |
etomidate ketamine endotracheal intubation anesthesia induction medications |
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 |