Prospective Study of Induction Medications Used in the Trauma RSI

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 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).

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

Conditions
-----------------
Trauma, Rapid Sequence Intubation

Intervention / Treatment
-----------------
* Drug: Ketamine
* Drug: Etomidate
* Drug: Propofol


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult trauma patients requiring RSI<br>Patients who received an induction medication for intubation. | Drug: Ketamine<br>* Administering ketamine as an induction medication for intubating adult trauma patients within 24 hours of hospital admission.<br>* Other names: Ketalar;Drug: Etomidate<br>* Administering etomidate as an induction medication for intubating adult trauma patients within 24 hours of hospital admission.<br>* Other names: Amidate;Drug: Propofol<br>* Administering propofol as an induction medication for intubating adult trauma patients within 24 hours of hospital admission.<br>* Other names: Diprivan;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-hospital mortality | mortality | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total hospital length of stay | days | through study completion, an average of 1 year | 
| intensive care unit length of stay | days | through study completion, an average of 1 year | 
| mechanical ventilator days | days | through study completion, an average of 1 year | 
| Number of participants with hypotension | defined as systolic blood pressure<90 mmHg or mean arterial pressure <50 mmHg | 30 minutes after intubation | 
| Number of participants with hypotension | defined as systolic blood pressure<90 mmHg or mean arterial pressure <50 mmHg | 24 hours after intubation | 
| Number of participants requiring vasopressor use | vasopressor use | 30 minutes after intubation | 
| Number of participants requiring vasopressor use | vasopressor use | 24 hours post intubation | 
| number of complications | examples: adrenal insufficiency, aspiration, pneumonia, acute respiratory distress syndrome, organ failure, etc. | through study completion, an average of 1 year | 
| 28-day mortality | 28 day mortality | 28 days after admission | 
| discharge disposition | examples: discharge home no services, home with services, skilled nursing facility, rehabilitation center, etc. | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
trauma, induction medications, rapid sequence intubations, outcomes