Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Los Angeles, California
Dates
study started
estimated completion

Description

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.

Official Title

Prospective Study of Induction Medications Used in the Rapid Sequence Intubation of Trauma Patients and a Comparison of Effects on Outcomes

Details

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).

Keywords

Trauma Rapid Sequence Intubation induction medications rapid sequence intubations outcomes Wounds and Injuries Ketamine Propofol Etomidate

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Location

  • Keck School of Medicine of the University of Southern California
    Los Angeles California 90033 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of Southern California
ID
NCT04291521
Study Type
Observational
Last Updated