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Ketamine Versus Etomidate for Rapid Sequence Intubation

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ClinicalTrials.gov Identifier: NCT01823328
Recruitment Status : Completed
First Posted : April 4, 2013
Results First Posted : May 24, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Hennepin Healthcare Research Institute.

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

Condition or disease Intervention/treatment Phase
Airway Control Anesthesia Intubation Complication Drug: Ketamine Drug: Etomidate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ketamine Versus Etomidate for Sedation of Emergency Department Patients During Rapid Sequence Intubation
Study Start Date : September 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


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:
  • Ketanest
  • Ketaset
  • Ketalar

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 Name: Amidate




Primary Outcome Measures :
  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 Outcome Measures :
  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:

    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


  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823328


Locations
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United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Hennepin Healthcare Research Institute.
Investigators
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Principal Investigator: Brian E Driver, MD Hennepin County Medical Canter

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Responsible Party: Hennepin Healthcare Research Institute.
ClinicalTrials.gov Identifier: NCT01823328     History of Changes
Other Study ID Numbers: HSR 13-3601
First Posted: April 4, 2013    Key Record Dates
Results First Posted: May 24, 2019
Last Update Posted: May 24, 2019
Last Verified: May 2019

Keywords provided by Hennepin Healthcare Research Institute.:
Intubation
Airway
Emergent intubation
Rapid sequence intubation
Rapid sequence induction
RSI
Ketamine
Etomidate
Sepsis
Sedative
Sedation

Additional relevant MeSH terms:
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Ketamine
Etomidate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives