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

University of Southern California

Status

Begins enrollment in 5 months

Conditions

Rapid Sequence Intubation

Trauma

Treatments

Drug: Propofol

Drug: Ketamine

Drug: Etomidate

Study type

Observational

Funder types

Other

Identifiers

NCT04291521

HS-20-00328

Details and patient eligibility

About

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.

Full 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).

Enrollment

7,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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