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

NCT02643381 | Completed Phase 4 Results DMC

• 1 other identifier: 022015-023
• Study Type: interventional
• Target: 801
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiopulmonary Arrest; Respiratory Arrest

Keywords

etomidate; ketamine; endotracheal intubation; anesthesia induction medications

Outcome Measures

Primary Outcomes (1)

• Survival at Day 7

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

  Day 7

Secondary Outcomes (7)

• Survival at Day 28

  Day 28

• Sequential Organ Failure Assessment (SOFA) Scores

  Day 1, Day 2, Day 3, Day 4

• Duration of Mechanical Ventilation

  From time of documented insertion until the time of documented removal, assessed up to 28 days

• Duration of Catecholamine Therapy

  From time of documented start of therapy until the time of documented end of therapy, assessed up to 28 days

• Length of Stay in ICU

  Assessed up to 28 days

Study Arms (2)

Etomidate

EXPERIMENTAL

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

Drug: Etomidate; Procedure: Emergency Endotracheal Intubation; Device: Mechanical Ventilation

Ketamine

EXPERIMENTAL

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

Drug: Ketamine; Procedure: Emergency Endotracheal Intubation; Device: Mechanical Ventilation

Interventions

Etomidate DRUG

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

Etomidate

Ketamine DRUG

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

Ketamine

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.

Etomidate; Ketamine

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.

Etomidate; Ketamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient (male or female) requiring emergency endotracheal intubation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Hospital

Dallas, Texas, 75235, United States

Location

Related Publications (2)

• 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.

  PMID: 29715485 RESULT

• 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.

  PMID: 34904190 DERIVED

MeSH Terms

Conditions

Heart Arrest; Apnea

Interventions

Etomidate; Ketamine; Respiration, Artificial

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Results Point of Contact

• Title: Gerald Matchett
• Organization: UT-Southwestern Medical Center

gerald.matchett@utsouthwestern.edu

214-648-6400

Study Officials

• Gerald Matchett, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 31, 2015
• Study Start: June 6, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 15, 2021
• Results First Posted: December 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)