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Completed

NCT Number: NCT01823328

Ketamine Versus Etomidate for Rapid Sequence Intubation

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

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Key information

Conditions

Airway Control Anesthesia Complication Infections Inflammation Intubation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

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

Other names: Ketanest, Ketaset, Ketalar

Etomidate

Drug

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

Other names: Amidate

Primary outcomes

  1. SOFA Score

    Time frame: up to 3 days

    *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.

Secondary outcomes

  1. Mortality in Sepsis and Septic Shock

    Time frame: 30 Days

    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

  2. Number of Patients With First-pass Success

    Time frame: up to 5 minutes (average time frame)

    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.

  3. Doses of Post-intubation Sedation

    Time frame: up to 6 hours

    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.

  4. Number of Patients With Post-intubation Hypoxemia

    Time frame: up to 2 hours

    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.

  5. Number of Patients With Hypotension

    Time frame: up to 6 hours

    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

  6. Peak and Plateau Pressure

    Time frame: up to 30 minutes (average time frame)

    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.

  7. Mortality

    Time frame: 30 Days or Discharge

    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).

Sponsors and collaborators

Lead sponsor

Hennepin Healthcare Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 4, 2013
Registry last updated
May 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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