Prospective Study of Induction Medications Used in the Trauma RSI

NCT04291521 | Withdrawn DMC

• 1 other identifier: HS-20-00328
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma; Rapid Sequence Intubation

Keywords

trauma; induction medications; rapid sequence intubations; outcomes

Outcome Measures

Primary Outcomes (1)

• in-hospital mortality

  mortality

  through study completion, an average of 1 year

Secondary Outcomes (10)

• total hospital length of stay

  through study completion, an average of 1 year

• intensive care unit length of stay

  through study completion, an average of 1 year

• mechanical ventilator days

  through study completion, an average of 1 year

• Number of participants with hypotension

  30 minutes after intubation

• Number of participants with hypotension

  24 hours after intubation

Study Arms (1)

Adult trauma patients requiring RSI

Patients who received an induction medication for intubation.

Drug: Ketamine; Drug: Etomidate; Drug: Propofol

Interventions

Ketamine DRUG

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

Also known as: Ketalar

Adult trauma patients requiring RSI

Etomidate DRUG

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

Also known as: Amidate

Adult trauma patients requiring RSI

Propofol DRUG

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

Also known as: Diprivan

Adult trauma patients requiring RSI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• University of California, Irvine: collaborator
• University of Texas: collaborator
• University of Chicago: collaborator
• Medical College of Wisconsin: collaborator

Study Sites (1)

Keck School of Medicine of the University of Southern California

Los Angeles, California, 90033, United States

Location

Related Publications (21)

• 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.

  PMID: 22560133 BACKGROUND

• 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.

  PMID: 19573904 BACKGROUND

• 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.

  PMID: 24723214 BACKGROUND

• 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.

  PMID: 20346542 BACKGROUND

• 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.

  PMID: 23318491 BACKGROUND

• 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.

  PMID: 19590307 BACKGROUND

• 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.

  PMID: 27993308 BACKGROUND

• 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.

  PMID: 19820598 BACKGROUND

• 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.

  PMID: 19625554 BACKGROUND

• 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.

  PMID: 26038005 BACKGROUND

• 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.

  PMID: 15496697 BACKGROUND

• 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.

  PMID: 19413824 BACKGROUND

• 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.

  PMID: 27130803 BACKGROUND

• 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.

  PMID: 25879683 BACKGROUND

• 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.

  PMID: 8955439 BACKGROUND

• 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.

  PMID: 12626974 BACKGROUND

• 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.

  PMID: 22101599 BACKGROUND

• 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.

  PMID: 9144065 RESULT

• 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.

  PMID: 27646281 RESULT

• 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.

  PMID: 23114490 RESULT

• 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.

  PMID: 23188232 RESULT

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Ketamine; Etomidate; Propofol

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic

Study Officials

• Catherine M Kuza, MD

  Keck School of Medicine of the University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 2, 2020
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): July 30, 2029
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)