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

Phase 4

Completed

Conditions: Respiratory Arrest
Cardiopulmonary Arrest

Interventions: Drug: Etomidate
Drug: Ketamine
Procedure: Emergency Endotracheal Intubation
Device: Mechanical Ventilation

Registration Number: NCT02643381

Lead Sponsor: University of Texas Southwestern Medical Center

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 801

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Etomidate	Mechanical Ventilation	Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.
Ketamine	Emergency Endotracheal Intubation	Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation.
Ketamine	Mechanical Ventilation	Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation.
Etomidate	Emergency Endotracheal Intubation	Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.
Etomidate	Etomidate	Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.
Ketamine	Ketamine	Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation.

Primary Outcome Measures

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

Secondary Outcome Measures

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