Clinical trial NCT02643381: Etomidate Versus Ketamine for Emergency Endotracheal Intubation: a Prospective Randomized Clinical Trial
Official title: Etomidate Versus Ketamine for Emergency Endotracheal Intubation: a Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiopulmonary Arrest
Respiratory Arrest
Keywords: etomidate
ketamine
endotracheal intubation
anesthesia induction medications
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2015-12-31
Enrollment: 801
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility 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.

Primary outcomes:
measure: Survival at Day 7
timeFrame: Day 7
Secondary outcomes:
measure: Survival at Day 28
timeFrame: Day 28
measure: Sequential Organ Failure Assessment (SOFA) Scores
timeFrame: Day 1, Day 2, Day 3, Day 4
measure: Duration of Mechanical Ventilation
timeFrame: From time of documented insertion until the time of documented removal, assessed up to 28 days
measure: Duration of Catecholamine Therapy
timeFrame: From time of documented start of therapy until the time of documented end of therapy, assessed up to 28 days
measure: Length of Stay in ICU
timeFrame: Assessed up to 28 days
measure: Number of Participants With New Diagnosis of Adrenal Insufficiency
timeFrame: Day 28
measure: Number of Attempts Necessary to Intubate
timeFrame: Immediate (Day 1)
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Hospital
state: Texas
Study officials:
affiliation: University of Texas
name: Gerald Matchett, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matchett G, Ryan TJ, Sunna MC, Lee SC, Pepe PE; EvK Clinical Trial Group. Measuring the cost and effect of current community consultation and public disclosure techniques in emergency care research. Resuscitation. 2018 Jul;128:37-42. doi: 10.1016/j.resuscitation.2018.04.033. Epub 2018 Apr 30.
citation: Matchett G, Gasanova I, Riccio CA, Nasir D, Sunna MC, Bravenec BJ, Azizad O, Farrell B, Minhajuddin A, Stewart JW, Liang LW, Moon TS, Fox PE, Ebeling CG, Smith MN, Trousdale D, Ogunnaike BO; EvK Clinical Trial Collaborators. Etomidate versus ketamine for emergency endotracheal intubation: a randomized clinical trial. Intensive Care Med. 2022 Jan;48(1):78-91. doi: 10.1007/s00134-021-06577-x. Epub 2021 Dec 14.