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WithdrawnNCT04291521ProTIMUpdated May 4, 2026

Prospective Study of Induction Medications Used in the Trauma RSI

An observational study in Trauma and Rapid Sequence Intubation, sponsored by University of Southern California. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by University of Southern California · Observational

Why this study was withdrawn
PI left institution.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Trauma
  • Rapid Sequence Intubation

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Keywords

  • trauma
  • induction medications
  • rapid sequence intubations
  • outcomes
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

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Lead sponsor

University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.

Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Adult trauma patients requiring RSI

    Patients who received an induction medication for intubation.

    Drug: Ketamine · Drug: Etomidate · Drug: Propofol

Interventions

  • DrugKetamine

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

    Also known as: Ketalar

  • DrugEtomidate

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

    Also known as: Amidate

  • DrugPropofol

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

    Also known as: Diprivan

06

What researchers measure

Primary outcomes

  1. in-hospital mortality

    mortality

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. total hospital length of stay

    days

    Time frame: through study completion, an average of 1 year

  2. intensive care unit length of stay

    days

    Time frame: through study completion, an average of 1 year

  3. mechanical ventilator days

    days

    Time frame: through study completion, an average of 1 year

  4. Number of participants with hypotension

    defined as systolic blood pressure\<90 mmHg or mean arterial pressure \<50 mmHg

    Time frame: 30 minutes after intubation

  5. Number of participants with hypotension

    defined as systolic blood pressure\<90 mmHg or mean arterial pressure \<50 mmHg

    Time frame: 24 hours after intubation

  6. Number of participants requiring vasopressor use

    vasopressor use

    Time frame: 30 minutes after intubation

  7. Number of participants requiring vasopressor use

    vasopressor use

    Time frame: 24 hours post intubation

  8. number of complications

    examples: adrenal insufficiency, aspiration, pneumonia, acute respiratory distress syndrome, organ failure, etc.

    Time frame: through study completion, an average of 1 year

  9. 28-day mortality

    28 day mortality

    Time frame: 28 days after admission

  10. discharge disposition

    examples: discharge home no services, home with services, skilled nursing facility, rehabilitation center, etc.

    Time frame: through study completion, an average of 1 year

07

Study locations

1 site
  • Keck School of Medicine of the University of Southern California
    Los Angeles, California 90033, United States
08

References and documents

Publications

  • Banh KV, James S, Hendey GW, Snowden B, Kaups K. Single-dose etomidate for intubation in the trauma patient. J Emerg Med. 2012 Nov;43(5):e277-82. doi: 10.1016/j.jemermed.2012.02.027. Epub 2012 May 3. PubMed 22560133 ↗
  • Jabre P, Combes X, Lapostolle F, Dhaouadi M, Ricard-Hibon A, Vivien B, Bertrand L, Beltramini A, Gamand P, Albizzati S, Perdrizet D, Lebail G, Chollet-Xemard C, Maxime V, Brun-Buisson C, Lefrant JY, Bollaert PE, Megarbane B, Ricard JD, Anguel N, Vicaut E, Adnet F; KETASED Collaborative Study Group. Etomidate versus ketamine for rapid sequence intubation in acutely ill patients: a multicentre randomised controlled trial. Lancet. 2009 Jul 25;374(9686):293-300. doi: 10.1016/S0140-6736(09)60949-1. Epub 2009 Jul 1. PubMed 19573904 ↗
  • Hinkewich C, Green R. The impact of etomidate on mortality in trauma patients. Can J Anaesth. 2014 Jul;61(7):650-5. doi: 10.1007/s12630-014-0161-6. Epub 2014 Apr 11. PubMed 24723214 ↗
  • Hohl CM, Kelly-Smith CH, Yeung TC, Sweet DD, Doyle-Waters MM, Schulzer M. The effect of a bolus dose of etomidate on cortisol levels, mortality, and health services utilization: a systematic review. Ann Emerg Med. 2010 Aug;56(2):105-13.e5. doi: 10.1016/j.annemergmed.2010.01.030. Epub 2010 Mar 25. PubMed 20346542 ↗
  • McPhee LC, Badawi O, Fraser GL, Lerwick PA, Riker RR, Zuckerman IH, Franey C, Seder DB. Single-dose etomidate is not associated with increased mortality in ICU patients with sepsis: analysis of a large electronic ICU database. Crit Care Med. 2013 Mar;41(3):774-83. doi: 10.1097/CCM.0b013e318274190d. PubMed 23318491 ↗
  • Warner KJ, Cuschieri J, Jurkovich GJ, Bulger EM. Single-dose etomidate for rapid sequence intubation may impact outcome after severe injury. J Trauma. 2009 Jul;67(1):45-50. doi: 10.1097/TA.0b013e3181a92a70. PubMed 19590307 ↗
  • Upchurch CP, Grijalva CG, Russ S, Collins SP, Semler MW, Rice TW, Liu D, Ehrenfeld JM, High K, Barrett TW, McNaughton CD, Self WH. Comparison of Etomidate and Ketamine for Induction During Rapid Sequence Intubation of Adult Trauma Patients. Ann Emerg Med. 2017 Jan;69(1):24-33.e2. doi: 10.1016/j.annemergmed.2016.08.009. PubMed 27993308 ↗
  • Fields AM, Rosbolt MB, Cohn SM. Induction agents for intubation of the trauma patient. J Trauma. 2009 Oct;67(4):867-9. doi: 10.1097/TA.0b013e3181b021c5. No abstract available. PubMed 19820598 ↗
  • Baird CR, Hay AW, McKeown DW, Ray DC. Rapid sequence induction in the emergency department: induction drug and outcome of patients admitted to the intensive care unit. Emerg Med J. 2009 Aug;26(8):576-9. doi: 10.1136/emj.2008.067801. PubMed 19625554 ↗
  • Zettervall SL, Sirajuddin S, Akst S, Valdez C, Golshani C, Amdur RL, Sarani B, Dunne JR. Use of propofol as an induction agent in the acutely injured patient. Eur J Trauma Emerg Surg. 2015 Aug;41(4):405-11. doi: 10.1007/s00068-014-0479-3. Epub 2014 Nov 20. PubMed 26038005 ↗
  • Choi YF, Wong TW, Lau CC. Midazolam is more likely to cause hypotension than etomidate in emergency department rapid sequence intubation. Emerg Med J. 2004 Nov;21(6):700-2. doi: 10.1136/emj.2002.004143. PubMed 15496697 ↗
  • Morris C, Perris A, Klein J, Mahoney P. Anaesthesia in haemodynamically compromised emergency patients: does ketamine represent the best choice of induction agent? Anaesthesia. 2009 May;64(5):532-9. doi: 10.1111/j.1365-2044.2008.05835.x. PubMed 19413824 ↗
  • Miller M, Kruit N, Heldreich C, Ware S, Habig K, Reid C, Burns B. Hemodynamic Response After Rapid Sequence Induction With Ketamine in Out-of-Hospital Patients at Risk of Shock as Defined by the Shock Index. Ann Emerg Med. 2016 Aug;68(2):181-188.e2. doi: 10.1016/j.annemergmed.2016.03.041. Epub 2016 Apr 27. PubMed 27130803 ↗
  • Lyon RM, Perkins ZB, Chatterjee D, Lockey DJ, Russell MQ; Kent, Surrey & Sussex Air Ambulance Trust. Significant modification of traditional rapid sequence induction improves safety and effectiveness of pre-hospital trauma anaesthesia. Crit Care. 2015 Apr 1;19(1):134. doi: 10.1186/s13054-015-0872-2. PubMed 25879683 ↗
  • Kolenda H, Gremmelt A, Rading S, Braun U, Markakis E. Ketamine for analgosedative therapy in intensive care treatment of head-injured patients. Acta Neurochir (Wien). 1996;138(10):1193-9. doi: 10.1007/BF01809750. PubMed 8955439 ↗
  • Bourgoin A, Albanese J, Wereszczynski N, Charbit M, Vialet R, Martin C. Safety of sedation with ketamine in severe head injury patients: comparison with sufentanil. Crit Care Med. 2003 Mar;31(3):711-7. doi: 10.1097/01.CCM.0000044505.24727.16. PubMed 12626974 ↗
  • Hughes S. Towards evidence based emergency medicine: best BETs from the Manchester Royal Infirmary. BET 3: is ketamine a viable induction agent for the trauma patient with potential brain injury. Emerg Med J. 2011 Dec;28(12):1076-7. doi: 10.1136/emermed-2011-200891. PubMed 22101599 ↗
  • Bergen JM, Smith DC. A review of etomidate for rapid sequence intubation in the emergency department. J Emerg Med. 1997 Mar-Apr;15(2):221-30. doi: 10.1016/s0736-4679(96)00350-2. PubMed 9144065 ↗
  • Pillay L, Hardcastle T. Collective Review of the Status of Rapid Sequence Intubation Drugs of Choice in Trauma in Low- and Middle-Income Settings (Prehospital, Emergency Department and Operating Room Setting). World J Surg. 2017 May;41(5):1184-1192. doi: 10.1007/s00268-016-3712-x. PubMed 27646281 ↗
  • Mayglothling J, Duane TM, Gibbs M, McCunn M, Legome E, Eastman AL, Whelan J, Shah KH; Eastern Association for the Surgery of Trauma. Emergency tracheal intubation immediately following traumatic injury: an Eastern Association for the Surgery of Trauma practice management guideline. J Trauma Acute Care Surg. 2012 Nov;73(5 Suppl 4):S333-40. doi: 10.1097/TA.0b013e31827018a5. PubMed 23114490 ↗
  • Ballow SL, Kaups KL, Anderson S, Chang M. A standardized rapid sequence intubation protocol facilitates airway management in critically injured patients. J Trauma Acute Care Surg. 2012 Dec;73(6):1401-5. doi: 10.1097/TA.0b013e318270dcf5. PubMed 23188232 ↗
  • Vekhova KA, Namiot ED, Jonsson J, Schioth HB. Ketamine and Esketamine in Clinical Trials: FDA-Approved and Emerging Indications, Trial Trends With Putative Mechanistic Explanations. Clin Pharmacol Ther. 2025 Feb;117(2):374-386. doi: 10.1002/cpt.3478. Epub 2024 Oct 20. PubMed 39428602 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04291521
Lead sponsor
University of Southern California
Collaborators
University of California, Irvine, University of Texas, University of Chicago, Medical College of Wisconsin
Responsible party
Catherine Kuza, MD (Assistant Professor, University of Southern California) — Principal investigator
First posted
Mar 2, 2020
Start date
Jan 1, 2027 (estimated)
Primary completion
Apr 30, 2029 (estimated)
Completion
Jul 30, 2029 (estimated)
Last update
May 4, 2026

Study contacts

Catherine M Kuza, MD
principal investigator · Keck School of Medicine of the University of Southern California

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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