Ketamine Versus Etomidate for Rapid Sequence Intubation

Hennepin Healthcare Research Institute143 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

143

Conditions

Airway Control Anesthesia Intubation Complication

Interventions

KetamineDRUG

Subjects will receive ketamine for sedation prior to rapid sequence intubation.

EtomidateDRUG

Subjects will receive etomidate for sedation prior to rapid sequence intubation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: up to 3 days

Secondary Outcomes

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: 1. Temperature \>38C or \<36C 2. Respiratory Rate \>20 or PaCO2 \<32 mmHg 3. Heart Rate \>90 4. 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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