Clinical trial NCT04291521: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Trauma
Rapid Sequence Intubation
Keywords: trauma
induction medications
rapid sequence intubations
outcomes
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: University of California, Irvine
name: University of Texas
name: University of Chicago
name: Medical College of Wisconsin
First posted: 2020-03-02
Enrollment: 7000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult trauma patients requiring intubation within 24 hours of hospital admission.

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).

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

Primary outcomes:
measure: in-hospital mortality
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: total hospital length of stay
timeFrame: through study completion, an average of 1 year
measure: intensive care unit length of stay
timeFrame: through study completion, an average of 1 year
measure: mechanical ventilator days
timeFrame: through study completion, an average of 1 year
measure: Number of participants with hypotension
timeFrame: 30 minutes after intubation
measure: Number of participants with hypotension
timeFrame: 24 hours after intubation
measure: Number of participants requiring vasopressor use
timeFrame: 30 minutes after intubation
measure: Number of participants requiring vasopressor use
timeFrame: 24 hours post intubation
measure: number of complications
timeFrame: through study completion, an average of 1 year
measure: 28-day mortality
timeFrame: 28 days after admission
measure: discharge disposition
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck School of Medicine of the University of Southern California
state: California
Study officials:
affiliation: Keck School of Medicine of the University of Southern California
name: Catherine M Kuza, MD
role: PRINCIPAL_INVESTIGATOR
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