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Comparison of Ketamine and Etomidate During Rapid Sequence Intubation in Trauma Patients

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ClinicalTrials.gov Identifier: NCT04120870
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : January 14, 2021
Sponsor:
Collaborator:
Unimedics (http://unimedics.co.kr)
Information provided by (Responsible Party):
In-kyong Yi, Ajou University School of Medicine

Tracking Information
First Submitted Date  ICMJE September 26, 2019
First Posted Date  ICMJE October 9, 2019
Last Update Posted Date January 14, 2021
Actual Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2019)
Systolic blood pressure difference compared with baseline after 10 minutes [ Time Frame: 13 minutes ]
Systolic blood pressure 10 minutes after induction agent injection - baseline systolic blood pressure mmHg Positive or zero value means good result. Negative value means poor result.
Original Primary Outcome Measures  ICMJE
 (submitted: October 8, 2019)
Systolic blood pressure difference compared with baseline after 10 minutes [ Time Frame: 13 minutes ]
Systolic blood pressure 10 minutes after induction agent injection - baseline systolic blood pressure
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2019)
  • Intubating condition [ Time Frame: 5 minutes ]
    Intubator judge intubating condition Laryngoscopy: easy / fair / difficult (difficult is the worst result) Vocal cords position: abducted / moving / closed (closed is the worst result) Reaction to insertion of the tracheal tube and cuff inflation : none / slight / vigorous (none is the worst result) If one of category checked the worst score, it considered :clinically unacceptable".
  • Incidence of hypotension [ Time Frame: 25 minutes ]
    If any of these are checked, define as hypotension (from injection of induction agent to 20 minutes after)
    1. systolic pressure < 90 mmHg
    2. systolic pressure decrease > 40% compared to baseline
    3. Initiation of vasopressor
    4. Vasopressor dose increase > 30% of initial vaopressor dose
    5. Fluid or blood loading
    Patient numbers (%)
  • Incidence of hypertension [ Time Frame: 25 miinutes ]
    From injection of induction agent to 20 minutes after, systolic pressure > 160 mmHg defined as hypertension Patients numbers (%)
Original Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2019)
  • Intubating condition [ Time Frame: 5 minutes ]
    Intubator judge intubating condition Laryngoscopy: easy / fair / difficult Vocal cords position: abducted / moving / closed Reaction to insertion of the tracheal tube and cuff inflation : none / slight / vigorous
  • Incidence of hypotension [ Time Frame: 25 minutes ]
    If any of these are checked, define as hypotension (from injection of induction agent to 20 minutes after)
    1. systolic pressure < 90 mmHg
    2. systolic pressure decrease > 40% compared to baseline
    3. Initiation of vasopressor
    4. Vasopressor dose increase > 30% of initial vaopressor dose
    5. Fluid or blood loading
  • Incidence of hypertension [ Time Frame: 25 miinutes ]
    From injection of induction agent to 20 minutes after, systolic pressure > 160 mmHg defined as hypertension
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Ketamine and Etomidate During Rapid Sequence Intubation in Trauma Patients
Official Title  ICMJE Comparison of Effects on Hemodynamics Between Ketamine and Etomidate During Rapid Sequence Intubation in Trauma Patients With High Shock Index
Brief Summary In trauma patients with high shock index, the investigators compare the effects on hemodynamics between ketamine and etomidate.
Detailed Description In trauma patients, rapid sequence intubation is recommended. The drug of choice, however, has been debated. One cohort comparative study showed ketamine had benefit in hemodynamics compared to etomidate in trauma patients. One observational study showed in high shock index patients, ketamine showed maintain systolic blood pressure. And other retrospective showed less clinical hypotension was less in ketamine. However there is no randomized controlled study comparing ketamine and etomidate in trauma patients. The purpose of this study is comparing the effects of hemodynamics between ketamine and etomidate in high shock index trauma patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
ketamine group: ketamine 2 mg/kg iv as induction agent etomidate group: etomidate 0.2 mg/kg iv as induction agent
Masking: None (Open Label)
Masking Description:
open label
Primary Purpose: Other
Condition  ICMJE
  • Trauma
  • Shock, Traumatic
Intervention  ICMJE
  • Drug: Etomidate Injection 0.2 mg/kg
    The induction agent of rapid sequence intubation is etomidate. 0.2 mg/kg
    Other Name: Etomidate
  • Drug: Ketamine injection 2 mg/kg
    The induction agent of rapid sequence intubation is ketamine. 2 mg/kg
    Other Name: Ketamine
Study Arms  ICMJE
  • Active Comparator: Etomidate
    The induction agent of rapid sequence intubation is etomidate. 0.2 mg/kg
    Intervention: Drug: Etomidate Injection 0.2 mg/kg
  • Experimental: Ketamine
    The induction agent of rapid sequence intubation is ketamine. 2 mg/kg
    Intervention: Drug: Ketamine injection 2 mg/kg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 8, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age 19~70
  • Shock index ≥ 0.9
  • Patients who need intubation regarding to Ajou trauma center protocol

Exclusion Criteria:

  • during CPR
  • CPR before hospital arrival
  • Severe head trauma
  • Steroid intake history
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: In Kyong Yi, MD +82-31-219-7522 lyrin01@gmail.com
Contact: Yo Heo, MD +82-31-219-7492 107696@aumc.ac.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04120870
Other Study ID Numbers  ICMJE MED-OBS-19-294
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: If there is a reasonable request, we can share the data personally.
Responsible Party In-kyong Yi, Ajou University School of Medicine
Study Sponsor  ICMJE Ajou University School of Medicine
Collaborators  ICMJE Unimedics (http://unimedics.co.kr)
Investigators  ICMJE
Principal Investigator: In Kyong Yi, MD Ajou University School of Medicine
PRS Account Ajou University School of Medicine
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP