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

April 28, 2026 updated by: Catherine Kuza, MD, University of Southern California

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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).

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Adult trauma patients requiring intubation within 24 hours of hospital admission.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult trauma patients requiring RSI
Patients who received an induction medication for intubation.
Drug: Ketamine
Administering ketamine as an induction medication for intubating adult trauma patients within 24 hours of hospital admission.
Other Names:
  • Ketalar
Drug: Etomidate
Administering etomidate as an induction medication for intubating adult trauma patients within 24 hours of hospital admission.
Other Names:
  • Amidate
Drug: Propofol
Administering propofol as an induction medication for intubating adult trauma patients within 24 hours of hospital admission.
Other Names:
  • Diprivan

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

University of Chicago
Medical College of Wisconsin
University of California, Irvine
University of Texas

Investigators

  • Principal Investigator: Catherine M Kuza, MD, Keck School of Medicine of the University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

April 30, 2029

Study Completion (Estimated)

July 30, 2029

Study Registration Dates

First Submitted

February 26, 2020

First Submitted That Met QC Criteria

February 27, 2020

First Posted (Actual)

March 2, 2020

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-20-00328

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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