Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04291521
Recruitment Status : Not yet recruiting
First Posted : March 2, 2020
Last Update Posted : February 3, 2022
Sponsor:
Collaborators:
University of California, Irvine
University of Texas
University of Chicago
Medical College of Wisconsin
Information provided by (Responsible Party):
Catherine Kuza, MD, 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.

Condition or disease Intervention/treatment
Trauma Rapid Sequence Intubation Drug: Ketamine Drug: Etomidate Drug: Propofol

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).

Layout table for study information
Study Type : Observational
Estimated Enrollment : 7000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study of Induction Medications Used in the Rapid Sequence Intubation of Trauma Patients and a Comparison of Effects on Outcomes
Estimated Study Start Date : January 1, 2023
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : July 30, 2024

Resource links provided by the National Library of Medicine


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 Name: Ketalar

Drug: Etomidate
Administering etomidate as an induction medication for intubating adult trauma patients within 24 hours of hospital admission.
Other Name: Amidate

Drug: Propofol
Administering propofol as an induction medication for intubating adult trauma patients within 24 hours of hospital admission.
Other Name: Diprivan




Primary Outcome Measures :
  1. in-hospital mortality [ Time Frame: through study completion, an average of 1 year ]
    mortality


Secondary Outcome Measures :
  1. total hospital length of stay [ Time Frame: through study completion, an average of 1 year ]
    days

  2. intensive care unit length of stay [ Time Frame: through study completion, an average of 1 year ]
    days

  3. mechanical ventilator days [ Time Frame: through study completion, an average of 1 year ]
    days

  4. Number of participants with hypotension [ Time Frame: 30 minutes after intubation ]
    defined as systolic blood pressure<90 mmHg or mean arterial pressure <50 mmHg

  5. Number of participants with hypotension [ Time Frame: 24 hours after intubation ]
    defined as systolic blood pressure<90 mmHg or mean arterial pressure <50 mmHg

  6. Number of participants requiring vasopressor use [ Time Frame: 30 minutes after intubation ]
    vasopressor use

  7. Number of participants requiring vasopressor use [ Time Frame: 24 hours post intubation ]
    vasopressor use

  8. 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.

  9. 28-day mortality [ Time Frame: 28 days after admission ]
    28 day mortality

  10. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adult trauma patients requiring intubation within 24 hours of hospital admission.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04291521


Contacts
Layout table for location contacts
Contact: Catherine M Kuza, MD 9089176330 catherine.kuza@med.usc.edu
Contact: Jeffry T Nahmias, MD 9493073035 jnahmias@uci.edu

Locations
Layout table for location information
United States, California
Keck School of Medicine of the University of Southern California
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
University of California, Irvine
University of Texas
University of Chicago
Medical College of Wisconsin
Investigators
Layout table for investigator information
Principal Investigator: Catherine M Kuza, MD Keck School of Medicine of the University of Southern California
Publications of Results:
Other Publications:

Layout table for additonal information
Responsible Party: Catherine Kuza, MD, Assistant Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT04291521    
Other Study ID Numbers: HS-20-00328
First Posted: March 2, 2020    Key Record Dates
Last Update Posted: February 3, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Catherine Kuza, MD, University of Southern California:
trauma
induction medications
rapid sequence intubations
outcomes
Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries
Ketamine
Propofol
Etomidate
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action