mortality
Prospective Study of Induction Medications Used in the Trauma RSI
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.
Intervention / Treatment
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Ketamine (DRUG)Administering ketamine as an induction medication for intubating adult trauma patients within 24 hours of hospital admission.
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Etomidate (DRUG)Administering etomidate as an induction medication for intubating adult trauma patients within 24 hours of hospital admission.
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Propofol (DRUG)Administering propofol as an induction medication for intubating adult trauma patients within 24 hours of hospital admission.
Condition or Disease
- Trauma
- Rapid Sequence Intubation
Phase
Study Design
| Study type: | OBSERVATIONAL |
|---|---|
| Status: | Not yet recruiting |
| Study results: | No Results Available |
| Age: | 18 Years and older (Adult, Older Adult) |
| Enrollment: | 7000 (ESTIMATED) |
| Funded by: | Other |
| Time Perspective: | Prospective |
| Observational Model: | Cohort |
Masking |
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Clinical Trial Dates
| Start date: | Jan 01, 2024 | ESTIMATED |
|---|---|---|
| Primary Completion: | Apr 30, 2026 | ESTIMATED |
| Completion Date: | Jul 30, 2026 | ESTIMATED |
| Study First Posted: | Mar 02, 2020 | ACTUAL |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Mar 12, 2023 |
Sponsors / Collaborators
Lead Sponsor:
University of Southern California
Responsible Party:
N/A
Location
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).
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).
Participant Groups
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Patients who received an induction medication for intubation.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Age Groups: | Adult / Older Adult |
| 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
* 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
Primary Outcomes
Secondary Outcomes
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days
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days
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days
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defined as systolic blood pressure\<90 mmHg or mean arterial pressure \<50 mmHg
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defined as systolic blood pressure\<90 mmHg or mean arterial pressure \<50 mmHg
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vasopressor use
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vasopressor use
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examples: adrenal insufficiency, aspiration, pneumonia, acute respiratory distress syndrome, organ failure, etc.
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28 day mortality
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examples: discharge home no services, home with services, skilled nursing facility, rehabilitation center, etc.
More Details
| NCT Number: | NCT04291521 |
|---|---|
| Acronym: | ProTIM |
| Other IDs: | HS-20-00328 |
| Study URL: | https://clinicaltrials.gov/study/NCT04291521 |
Last updated: Sep 29, 2023