Phase 4
N=801
Etomidate Versus Ketamine for Emergency Endotracheal Intubation: a Prospective Randomized Clinical Trial
Cardiopulmonary Arrest · Respiratory Arrest
Bottom Line
View on ClinicalTrials.gov: NCT02643381 ↗Enrolled (actual)
801
Serious AEs
2.4%
Results posted
Dec 2021
Primary outcome: Primary: Survival at Day 7 — 306; 336 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Etomidate (Drug); Ketamine (Drug); Emergency Endotracheal Intubation (Procedure); Mechanical Ventilation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survival at Day 7 |
306; 336 | — |
| SECONDARY Survival at Day 28 |
254; 264 | — |
| SECONDARY Sequential Organ Failure Assessment (SOFA) Scores |
10.7; 10.9; 9.8; 9.5; 8.4; 8.4 | — |
| SECONDARY Duration of Mechanical Ventilation |
5; 5 | — |
| SECONDARY Duration of Catecholamine Therapy |
1; 1 | — |
| SECONDARY Length of Stay in ICU |
8; 9 | — |
| SECONDARY Number of Participants With New Diagnosis of Adrenal Insufficiency |
11; 4 | — |
| SECONDARY Number of Attempts Necessary to Intubate |
357; 355; 29; 26; 4; 5 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02643381). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.