Prospective Study of Induction Medications Used in the Trauma RSI
- Conditions
- TraumaRapid Sequence Intubation
- Interventions
- Registration Number
- NCT04291521
- Lead Sponsor
- University of Southern California
- 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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 7000
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Adult trauma patients requiring RSI Ketamine Patients who received an induction medication for intubation. Adult trauma patients requiring RSI Propofol Patients who received an induction medication for intubation. Adult trauma patients requiring RSI Etomidate Patients who received an induction medication for intubation.
- Primary Outcome Measures
Name Time Method in-hospital mortality through study completion, an average of 1 year mortality
- Secondary Outcome Measures
Name Time Method mechanical ventilator days through study completion, an average of 1 year days
intensive care unit length of stay through study completion, an average of 1 year days
total hospital length of stay through study completion, an average of 1 year days
Number of participants requiring vasopressor use 24 hours post intubation vasopressor use
28-day mortality 28 days after admission 28 day mortality
discharge disposition through study completion, an average of 1 year examples: discharge home no services, home with services, skilled nursing facility, rehabilitation center, etc.
Number of participants with hypotension 24 hours after intubation defined as systolic blood pressure\<90 mmHg or mean arterial pressure \<50 mmHg
number of complications through study completion, an average of 1 year examples: adrenal insufficiency, aspiration, pneumonia, acute respiratory distress syndrome, organ failure, etc.
Trial Locations
- Locations (1)
Keck School of Medicine of the University of Southern California
🇺🇸Los Angeles, California, United States