Ketamine Versus Etomidate for Rapid Sequence Intubation

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

Detailed Description
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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.

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

Conditions
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Anesthesia, Airway Control, Intubation, Complication

Intervention / Treatment
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* Drug: Ketamine
* Drug: Etomidate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketamine<br>Subjects in the ketamine arm will receive ketamine for sedation prior to rapid sequence intubation (RSI). | Drug: Ketamine<br>* Subjects will receive ketamine for sedation prior to rapid sequence intubation.<br>* Other names: Ketalar;|
| Active Comparator: Etomidate<br>Subjects in the etomidate arm will receive etomidate for sedation prior to rapid sequence intubation (RSI). | Drug: Etomidate<br>* Subjects will receive etomidate for sedation prior to rapid sequence intubation.<br>* Other names: Amidate;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intubation, Airway, Emergent intubation, Rapid sequence intubation, Rapid sequence induction, RSI, Ketamine, Etomidate, Sepsis, Sedative, Sedation