Prospective Study of Induction Medications Used in the Rapid Sequence Intubation of Trauma Patients and a Comparison of Effects on Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 7,000
- 试验地点
- 2
- 主要终点
- in-hospital mortality
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Adult trauma patients requiring RSI
Patients who received an induction medication for intubation.
干预措施: Ketamine (Drug)
Adult trauma patients requiring RSI
Patients who received an induction medication for intubation.
干预措施: Propofol (Drug)
Adult trauma patients requiring RSI
Patients who received an induction medication for intubation.
干预措施: Etomidate (Drug)
结局指标
主要结局
in-hospital mortality
时间窗: through study completion, an average of 1 year
mortality
次要结局
- 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)
- total hospital length of stay(through study completion, an average of 1 year)
- Number of participants requiring vasopressor use(24 hours post intubation)
- 28-day mortality(28 days after admission)
- discharge disposition(through study completion, an average of 1 year)
- Number of participants with hypotension(24 hours after intubation)
- number of complications(through study completion, an average of 1 year)
- Number of participants with hypotension(30 minutes after intubation)
- Number of participants requiring vasopressor use(30 minutes after intubation)
研究者
Catherine Kuza, MD
Assistant Professor
University of Southern California