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Prospective Study of Induction Medications Used in the Trauma RSI (ProTIM)

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ClinicalTrials.gov Identifier: NCT04291521
Recruitment Status : Not yet recruiting
First Posted : March 2, 2020
Last Update Posted : November 12, 2020
Sponsor:
Collaborators:
University of California, Irvine
University of Texas
University of Chicago
Medical College of Wisconsin
Information provided by (Responsible Party):
Catherine Kuza, MD, University of Southern California

Tracking Information
First Submitted Date February 26, 2020
First Posted Date March 2, 2020
Last Update Posted Date November 12, 2020
Estimated Study Start Date January 1, 2021
Estimated Primary Completion Date March 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 27, 2020)
in-hospital mortality [ Time Frame: through study completion, an average of 1 year ]
mortality
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 27, 2020)
  • total hospital length of stay [ Time Frame: through study completion, an average of 1 year ]
    days
  • intensive care unit length of stay [ Time Frame: through study completion, an average of 1 year ]
    days
  • mechanical ventilator days [ Time Frame: through study completion, an average of 1 year ]
    days
  • Number of participants with hypotension [ Time Frame: 30 minutes after intubation ]
    defined as systolic blood pressure<90 mmHg or mean arterial pressure <50 mmHg
  • Number of participants with hypotension [ Time Frame: 24 hours after intubation ]
    defined as systolic blood pressure<90 mmHg or mean arterial pressure <50 mmHg
  • Number of participants requiring vasopressor use [ Time Frame: 30 minutes after intubation ]
    vasopressor use
  • Number of participants requiring vasopressor use [ Time Frame: 24 hours post intubation ]
    vasopressor use
  • number of complications [ Time Frame: through study completion, an average of 1 year ]
    examples: adrenal insufficiency, aspiration, pneumonia, acute respiratory distress syndrome, organ failure, etc.
  • 28-day mortality [ Time Frame: 28 days after admission ]
    28 day mortality
  • discharge disposition [ Time Frame: through study completion, an average of 1 year ]
    examples: discharge home no services, home with services, skilled nursing facility, rehabilitation center, etc.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Study of Induction Medications Used in the Trauma RSI
Official Title Prospective Study of Induction Medications Used in the Rapid Sequence Intubation of Trauma Patients and a Comparison of Effects on Outcomes
Brief Summary To compare the outcomes of the use of propofol, etomidate, and ketamine as induction agents for adult trauma patients undergoing intubation within 24 hours of admission. The primary goal is to determine the ideal agent that should be used in this patient population for intubations.
Detailed Description

Rationale:

Although rapid sequence intubation (RSI) is commonly used in the emergency department (ED) or operating room (OR) for trauma patients, there is not one induction medication which has been deemed the drug of choice for this particular use. There is a wide variation in induction agents used by providers performing RSIs, including propofol, ketamine, methohexital, midazolam, fentanyl, and etomidate. However, no society guidelines exist on the induction agent of choice in trauma for either hemodynamically stable or unstable patients. The purpose of this study is to compare the effects of 3 of the most commonly used induction agents (propofol, etomidate, and ketamine) for RSIs in adult trauma patients on outcomes, such as mortality, and hemodynamic status. Ultimately, the investigators would like to lay the groundwork for developing guidelines that define the ideal induction agent for trauma RSIs.

Intervention: Giving propofol, ketamine, or etomidate as the induction medication for a rapid sequence intubation in trauma patients requiring intubation within 24 hours of admission.

Objectives/Purpose: The purpose of this study is to compare the effects of 3 of the most commonly used induction agents (propofol, etomidate, and ketamine) for RSIs in adult trauma patients on outcomes such as mortality. Additionally, how each agent effects patients' hemodynamic status will be evaluated. Additional outcomes of these medications will be studied in three subsets of patients: 1. those with traumatic brain injuries, 2. elderly patients (>=65-years-old), and 3. those with a low shock index (<0.9) compared to a high shock index (>0.9). Finally, the practices and outcomes of RSIs performed in the ED versus the OR will be compared. Ultimately, the investigators would like to lay the groundwork for developing guidelines that define the ideal induction agent for trauma RSIs.

Study population: Adult trauma patients undergoing RSI within 24 hours of hospital admission

Methodology: A multicenter, prospective observational study will be performed.

Endpoints: In-hospital mortality, 28-day mortality, ICU and total hospital length of stay, complications, hypotension and vasopressor use 30 minutes and 24 hours after intubation, mechanical ventilator days, and discharge disposition

Statistic plan: Data will be entered into a password-protected online data collection tool known as RedCap, and analyzed using SAS version 9.4 (SAS Institute, Inc., Cary, NC).

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adult trauma patients requiring intubation within 24 hours of hospital admission.
Condition
  • Trauma
  • Rapid Sequence Intubation
Intervention
  • Drug: Ketamine
    Administering ketamine as an induction medication for intubating adult trauma patients within 24 hours of hospital admission.
    Other Name: Ketalar
  • Drug: Etomidate
    Administering etomidate as an induction medication for intubating adult trauma patients within 24 hours of hospital admission.
    Other Name: Amidate
  • Drug: Propofol
    Administering propofol as an induction medication for intubating adult trauma patients within 24 hours of hospital admission.
    Other Name: Diprivan
Study Groups/Cohorts Adult trauma patients requiring RSI
Patients who received an induction medication for intubation.
Interventions:
  • Drug: Ketamine
  • Drug: Etomidate
  • Drug: Propofol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: February 27, 2020)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 30, 2022
Estimated Primary Completion Date March 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Trauma patients >=18 yo requiring intubation within 24 hours of admission in either the ED or OR
  • Patients received propofol, etomidate, or ketamine for induction agent

Exclusion Criteria:

  • Patients who were intubated without induction agent medications
  • Patients intubated outside of the hospital or in the field
  • Patients who were intubated with an induction agent other than etomidate, ketamine, or propofol
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Catherine M Kuza, MD 9089176330 catherine.kuza@med.usc.edu
Contact: Jeffry T Nahmias, MD 9493073035 jnahmias@uci.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04291521
Other Study ID Numbers APP-20-00661
Has Data Monitoring Committee Yes
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
Plan to Share IPD: Undecided
Responsible Party Catherine Kuza, MD, University of Southern California
Study Sponsor University of Southern California
Collaborators
  • University of California, Irvine
  • University of Texas
  • University of Chicago
  • Medical College of Wisconsin
Investigators
Principal Investigator: Catherine M Kuza, MD Keck School of Medicine of the University of Southern California
PRS Account University of Southern California
Verification Date November 2020