Prospective Study of Induction Medications Used in the Trauma RSI

Trauma Clinical Trial

— ProTIM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04291521
• Other study ID #: HS-20-00328
• Status: Not yet recruiting
• Start date: January 1, 2026
• Est. completion date: July 30, 2028

Study information

• Verified date: March 2024
• Source: University of Southern California
• Contact: Catherine M Kuza, MD
• Phone: 9089176330
• Email: catherine.kuza[@]med.usc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 7000
• Est. completion date: July 30, 2028
• Est. primary completion date: April 30, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rapid Sequence Intubation
• Trauma
• Wounds and Injuries

Intervention

Drug:
• Ketamine
Administering ketamine as an induction medication for intubating adult trauma patients within 24 hours of hospital admission.
• Etomidate
Administering etomidate as an induction medication for intubating adult trauma patients within 24 hours of hospital admission.
• Propofol
Administering propofol as an induction medication for intubating adult trauma patients within 24 hours of hospital admission.

Locations

Country	Name	City	State
United States	Keck School of Medicine of the University of Southern California	Los Angeles	California

Sponsors (5)

Lead Sponsor	Collaborator
University of Southern California	Medical College of Wisconsin, University of California, Irvine, University of Chicago, University of Texas

Country where clinical trial is conducted

United States, 

References & Publications (21)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Acta Neurochir (Wien) 1997;139(12):1193. — View Citation

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. — View Citation

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 pra — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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: — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

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