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

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ClinicalTrials.gov Identifier: NCT02643381
Recruitment Status : Recruiting
First Posted : December 31, 2015
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE December 11, 2015
First Posted Date  ICMJE December 31, 2015
Last Update Posted Date January 17, 2019
Actual Study Start Date  ICMJE June 6, 2016
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2015)
Survival [ Time Frame: Day 7 ]
Survival at day 7 following emergency endotracheal intubation.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02643381 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2015)
  • Survival [ Time Frame: Day 28 ]
    Survival at day 28 following emergency endotracheal intubation.
  • Sequential Organ Failure Assessment (SOFA) scores [ Time Frame: Day 0-28 ]
    SOFA scores following emergency endotracheal intubation.
  • Immediate outcomes of endotracheal intubation. [ Time Frame: Day 0 ]
    Each intubation will be assessed for specific immediate outcomes including the following: Number of attempts required to successfully intubate the patient and the presence or absence of specific traumatic complications that are known risks of the procedure including oral / dental trauma, bleeding, and/or aspiration.
  • Duration of mechanical ventilation. [ Time Frame: Day 0-28 ]
    Duration of mechanical ventilation.
  • Duration of catecholamine therapy [ Time Frame: Day 0-28 ]
    Duration of catecholamine therapy
  • Length of stay in ICU / hospital [ Time Frame: Day 0-28 ]
    Length of stay in ICU / hospital
  • New diagnosis of adrenal insufficiency [ Time Frame: Day 0-28 ]
    Specific testing for adrenal insufficiency will not be performed as part of the study. However, the charts of all patients enrolled in the study will be assessed to see if the primary treating medical or surgical team has made a diagnosis of adrenal insufficiency. The total number of subjects with this new diagnosis will be recorded.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Etomidate Versus Ketamine for Emergency Endotracheal Intubation: a Prospective Randomized Clinical Trial
Official Title  ICMJE Etomidate Versus Ketamine for Emergency Endotracheal Intubation: a Prospective Randomized Clinical Trial
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiopulmonary Arrest
  • Respiratory Arrest
Intervention  ICMJE
  • Drug: Etomidate
    Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.
  • Drug: 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.
Study Arms  ICMJE
  • Experimental: Etomidate
    Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.
    Interventions:
    • Drug: Etomidate
    • Procedure: Emergency Endotracheal Intubation
    • Device: Mechanical Ventilation
  • Experimental: Ketamine
    Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation.
    Interventions:
    • Drug: Ketamine
    • Procedure: Emergency Endotracheal Intubation
    • Device: Mechanical Ventilation
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 29, 2015)
825
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gerald Matchett, MD 214-648-6400 info@evktrial.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02643381
Other Study ID Numbers  ICMJE 022015-023
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Aggregate anonymous data will be published in accord with our IRB approval.
Responsible Party University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gerald Matchett, MD University of Texas
PRS Account University of Texas Southwestern Medical Center
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP