Prospective Study of Induction Medications Used in the Trauma RSI (ProTIM)
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| ClinicalTrials.gov Identifier: NCT04291521 |
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Recruitment Status :
Not yet recruiting
First Posted : March 2, 2020
Last Update Posted : February 3, 2022
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| Condition or disease | Intervention/treatment |
|---|---|
| Trauma Rapid Sequence Intubation | Drug: Ketamine Drug: Etomidate Drug: Propofol |
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).
| 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 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Adult trauma patients requiring RSI
Patients who received an induction medication for intubation.
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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 |
- in-hospital mortality [ Time Frame: through study completion, an average of 1 year ]mortality
- total hospital length of stay [ Time Frame: through study completion, an average of 1 year ]days
- intensive care unit length of stay [ Time Frame: through study completion, an average of 1 year ]days
- mechanical ventilator days [ Time Frame: through study completion, an average of 1 year ]days
- Number of participants with hypotension [ Time Frame: 30 minutes after intubation ]defined as systolic blood pressure<90 mmHg or mean arterial pressure <50 mmHg
- Number of participants with hypotension [ Time Frame: 24 hours after intubation ]defined as systolic blood pressure<90 mmHg or mean arterial pressure <50 mmHg
- Number of participants requiring vasopressor use [ Time Frame: 30 minutes after intubation ]vasopressor use
- Number of participants requiring vasopressor use [ Time Frame: 24 hours post intubation ]vasopressor use
- 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.
- 28-day mortality [ Time Frame: 28 days after admission ]28 day mortality
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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
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
| Contact: Catherine M Kuza, MD | 9089176330 | catherine.kuza@med.usc.edu | |
| Contact: Jeffry T Nahmias, MD | 9493073035 | jnahmias@uci.edu |
| United States, California | |
| Keck School of Medicine of the University of Southern California | |
| Los Angeles, California, United States, 90033 | |
| Principal Investigator: | Catherine M Kuza, MD | Keck School of Medicine of the University of Southern California |
Other Publications:
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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trauma induction medications rapid sequence intubations outcomes |
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