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Prospective Study of Induction Medications Used in the Trauma RSI

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04291521
Acronym
ProTIM
Enrollment
0
Registered
2020-03-02
Start date
2027-01-01
Completion date
2029-07-30
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rapid Sequence Intubation, Trauma

Keywords

trauma, induction medications, rapid sequence intubations, outcomes

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).

Interventions

DRUGKetamine

Administering ketamine as an induction medication for intubating adult trauma patients within 24 hours of hospital admission.

DRUGEtomidate

Administering etomidate as an induction medication for intubating adult trauma patients within 24 hours of hospital admission.

DRUGPropofol

Administering propofol as an induction medication for intubating adult trauma patients within 24 hours of hospital admission.

Sponsors

University of Southern California
Lead SponsorOTHER
University of California, Irvine
CollaboratorOTHER
University of Texas
CollaboratorOTHER
University of Chicago
CollaboratorOTHER
Medical College of Wisconsin
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
in-hospital mortalitythrough study completion, an average of 1 yearmortality

Secondary

MeasureTime frameDescription
total hospital length of staythrough study completion, an average of 1 yeardays
intensive care unit length of staythrough study completion, an average of 1 yeardays
mechanical ventilator daysthrough study completion, an average of 1 yeardays
Number of participants with hypotension30 minutes after intubationdefined as systolic blood pressure\<90 mmHg or mean arterial pressure \<50 mmHg
Number of participants requiring vasopressor use30 minutes after intubationvasopressor use
number of complicationsthrough study completion, an average of 1 yearexamples: adrenal insufficiency, aspiration, pneumonia, acute respiratory distress syndrome, organ failure, etc.
28-day mortality28 days after admission28 day mortality
discharge dispositionthrough study completion, an average of 1 yearexamples: discharge home no services, home with services, skilled nursing facility, rehabilitation center, etc.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORCatherine M Kuza, MD

Keck School of Medicine of the University of Southern California

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 5, 2026