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

Cardiopulmonary Arrest Clinical Trial

— EvK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02643381
• Other study ID #: 022015-023
• Status: Completed
• Phase: Phase 4
• Start date: June 6, 2016
• Est. completion date: December 1, 2020

Study information

• Verified date: November 2021
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 801
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Cardiopulmonary Arrest
• Emergencies
• Heart Arrest
• Respiratory Arrest

Intervention

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

Locations

Country	Name	City	State
United States	Parkland Hospital	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.resusc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival at Day 7	Survival is defined as the number of participants survived at day 7 following emergency endotracheal intubation	Day 7
Secondary	Survival at Day 28	Survival is defined as the number of participants survived at day 28 following emergency endotracheal intubation	Day 28
Secondary	Sequential Organ Failure Assessment (SOFA) Scores	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	Day 1, Day 2, Day 3, Day 4
Secondary	Duration of Mechanical Ventilation	Duration (in days) from insertion to removal of mechanical ventilation	From time of documented insertion until the time of documented removal, assessed up to 28 days
Secondary	Duration of Catecholamine Therapy	Time (in days) from start to end of catecholamine therapy	From time of documented start of therapy until the time of documented end of therapy, assessed up to 28 days
Secondary	Length of Stay in ICU	Length (in days) of ICU stay	Assessed up to 28 days
Secondary	Number of Participants With New Diagnosis of Adrenal Insufficiency	New diagnosis of adrenal insufficiency will be assessed by the the primary treating medical or surgical team via chart review	Day 28
Secondary	Number of Attempts Necessary to Intubate	This referrers to the number of documented intubation attempts necessary to intubate the patient.	Immediate (Day 1)