Prospective Study of Induction Medications Used in the Rapid Sequence Intubation of Trauma Patients and a Comparison of Effects on Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Enrollment
- 7,000
- Locations
- 1
- Primary Endpoint
- in-hospital mortality
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Adult trauma patients requiring RSI
Patients who received an induction medication for intubation.
Intervention: Propofol (Drug)
Adult trauma patients requiring RSI
Patients who received an induction medication for intubation.
Intervention: Ketamine (Drug)
Adult trauma patients requiring RSI
Patients who received an induction medication for intubation.
Intervention: Etomidate (Drug)
Outcomes
Primary Outcomes
in-hospital mortality
Time Frame: through study completion, an average of 1 year
mortality
Secondary Outcomes
- Number of participants with hypotension(30 minutes after intubation)
- Number of participants requiring vasopressor use(30 minutes after intubation)
- intensive care unit length of stay(through study completion, an average of 1 year)
- mechanical ventilator days(through study completion, an average of 1 year)
- total hospital length of stay(through study completion, an average of 1 year)
- Number of participants requiring vasopressor use(24 hours post intubation)
- 28-day mortality(28 days after admission)
- discharge disposition(through study completion, an average of 1 year)
- Number of participants with hypotension(24 hours after intubation)
- number of complications(through study completion, an average of 1 year)
Investigators
Catherine Kuza, MD
Assistant Professor
University of Southern California