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

NCT ID: NCT02643381

Last Updated: 2021-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 801 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-06
• Study Completion Date: 2020-12-01

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).

Conditions

Cardiopulmonary Arrest; Respiratory Arrest

Keywords

etomidate; ketamine; endotracheal intubation; anesthesia induction medications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Etomidate

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

Group Type: EXPERIMENTAL

Etomidate

Intervention Type: DRUG

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

Emergency Endotracheal Intubation

Intervention Type: 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

Intervention Type: 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.

Ketamine

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

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

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

Emergency Endotracheal Intubation

Intervention Type: 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

Intervention Type: 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.

Interventions

Etomidate

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

Intervention Type: DRUG

Ketamine

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

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Gerald Matchett

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerald Matchett, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

Parkland Hospital

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 29715485 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34904190 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

022015-023

Identifier Type: -

Identifier Source: org_study_id