Ketamine Versus Etomidate for Rapid Sequence Intubation

Ketamine Versus Etomidate for Sedation of Emergency Department Patients During Rapid Sequence Intubation

The purpose of this study is to compare the effectiveness and safety of ketamine and etomidate during rapid sequence intubation (RSI).

Study Overview

• Status: Completed
• Conditions: Intubation; Anesthesia; Complication; Airway Control
• Intervention / Treatment: Drug: Ketamine; Drug: Etomidate

Detailed Description

This study is a randomized controlled trial of etomidate versus ketamine during rapid sequence intubation (RSI). RSI refers to the process by which patients who require emergency airway management undergo sedation and paralysis prior to insertion of an endotracheal tube(airway tube). Patients who require intubation will be randomized to have intubation performed with either ketamine or etomidate. All other care will be at the discretion of the treating physicians. The purpose of this study is to compare the efficacy and safety of ketamine and etomidate during rapid sequence intubation.

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age
• Undergoing rapid sequence intubation (RSI) in the Emergency Department

Exclusion Criteria:

• Known contraindication to ketamine or etomidate
• Patient has a condition in which an increase in heart rate or blood pressure would be hazardous, as judged by the treating physician
• Patient is known or suspected of having increased intracranial pressure, based on the history and physical examination performed by the treating physician.
• Females of child-bearing age, defined as 18-50 years, who do not have a documented pregnancy test in this institution confirming that they are not pregnant or who do not have a confirmed surgical procedure preventing pregnancy, i.e., tubal ligation, hysterectomy. The timing of the pregnancy test at which the investigative team will consider a subject to be non-pregnant is a documented negative test during current hospitalization or upon direct transfer from outside institution during current illness.
• Patient declines participation in the trial by wearing a bracelet marked "KvE declined"
• Prisoner

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Ketamine; Subjects in the ketamine arm will receive ketamine for sedation prior to rapid sequence intubation (RSI).	Drug: Ketamine; Subjects will receive ketamine for sedation prior to rapid sequence intubation.; Other Names: Ketalar; Ketanest; Ketaset
ACTIVE_COMPARATOR: Etomidate; Subjects in the etomidate arm will receive etomidate for sedation prior to rapid sequence intubation (RSI).	Drug: Etomidate; Subjects will receive etomidate for sedation prior to rapid sequence intubation.; Other Names: Amidate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SOFA Score	*Maximum SOFA score within three hospital days: all patients. SOFA score is the Sequential Organ Failure Assessment. The minimum score is 0, the maximum score is 24, with higher scores indicating higher likelihood of worse outcome.	up to 3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality in Sepsis and Septic Shock	Evaluate mortality for the sub-group diagnosed with sepsis and septic shock, defined as: - Suspected infection, and at least 2 of 4 systemic inflammatory response syndrome (SIRS) criteria: Temperature >38C or <36C; Respiratory Rate >20 or PaCO2 <32 mmHg; Heart Rate >90; White blood cell count >12,000 or <4,000, or > 10% bands Septic shock: defined as sepsis plus either: 1) Systolic blood pressure <90 after 1L of intravenous fluid or 2) lactate >=4mmol/L	30 Days
Number of Patients With First-pass Success	The rate of first pass success, defined as successful tracheal intubation on the first attempt. An attempt is defined as the insertion and subsequent removal of the laryngoscopic device from the patient's mouth, regardless of whether an endotracheal tube was inserted.	up to 5 minutes (average time frame)
Doses of Post-intubation Sedation	The number of bolus doses of sedative administered post-intubation will be compared up to 6 hours (including morphine, dexmedetomidine, propofol , etomidate, ketamine, lorazepam (Ativan), midazolam (Versed), diazepam (Valium), fentanyl, hydromorphone (Dilaudid)). Infusions of these medications will be recorded separately but will not be part of this outcome.	up to 6 hours
Number of Patients With Post-intubation Hypoxemia	The following will be compared between the two groups: Hypoxemia and severe hypoxemia in the peri-intubation period. Peri-intubation hypoxemia was defined as during after the 5 minutes immediately after intubation.; Hypoxemia within the first 2 hours intubation Hypoxemia is defined as SpO2 less than 90%. Severe hypoxemia is defined as SpO2 less than 90% for 60 seconds or more.	up to 2 hours
Number of Patients With Hypotension	The following will be compared between the two groups: Hypotension in the ED post-intubation; Hypotension within the first 6 hours of the hospital stay, including time spent in the ED Hypotension is defined as a systolic blood pressure less than 90 mm Hg	up to 6 hours
Peak and Plateau Pressure	The Peak and plateau pressures will be compared between the two groups, with a pre-defined subgroup analysis of patients who are being intubated for severe asthma and chronic obstructive pulmonary disease (COPD). The ventilator was used to measure these values.	up to 30 minutes (average time frame)
Mortality	Mortality will be assessed at 30 days or at discharge from the hospital, whichever occurs first. This study is not powered to detect a significant difference in mortality, however; this will primarily be a safety study comparing the use ketamine versus etomidate as sedative agents for rapid sequence intubation (RSI) in the Emergency Department (ED).	30 Days or Discharge

Collaborators and Investigators

• Sponsor: Hennepin Healthcare Research Institute
• Investigators: Principal Investigator: Brian E Driver, MD, Hennepin County Medical Canter

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ACTUAL): October 1, 2015
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: March 28, 2013
• First Submitted That Met QC Criteria: April 2, 2013
• First Posted (ESTIMATE): April 4, 2013

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2019
• Last Update Submitted That Met QC Criteria: May 2, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Ketamine; Sedation; Sepsis; Intubation; Airway; Rapid sequence induction; Rapid sequence intubation; RSI; Etomidate; Sedative; Emergent intubation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Hypnotics and Sedatives; Ketamine; Etomidate
• Other Study ID Numbers: HSR 13-3601