Ketamine Versus Etomidate for Sedation of Emergency Department Patients During Rapid Sequence Intubation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- SOFA Score
研究概览
简要总结
The purpose of this study is to compare the effectiveness and safety of ketamine and etomidate during rapid sequence intubation (RSI).
详细描述
This study is a randomized controlled trial of etomidate versus ketamine during rapid sequence intubation (RSI). RSI refers to the process by which patients who require emergency airway management undergo sedation and paralysis prior to insertion of an endotracheal tube(airway tube). Patients who require intubation will be randomized to have intubation performed with either ketamine or etomidate. All other care will be at the discretion of the treating physicians. The purpose of this study is to compare the efficacy and safety of ketamine and etomidate during rapid sequence intubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age
- •Undergoing rapid sequence intubation (RSI) in the Emergency Department
排除标准
- •Known contraindication to ketamine or etomidate
- •Patient has a condition in which an increase in heart rate or blood pressure would be hazardous, as judged by the treating physician
- •Patient is known or suspected of having increased intracranial pressure, based on the history and physical examination performed by the treating physician.
- •Females of child-bearing age, defined as 18-50 years, who do not have a documented pregnancy test in this institution confirming that they are not pregnant or who do not have a confirmed surgical procedure preventing pregnancy, i.e., tubal ligation, hysterectomy. The timing of the pregnancy test at which the investigative team will consider a subject to be non-pregnant is a documented negative test during current hospitalization or upon direct transfer from outside institution during current illness.
- •Patient declines participation in the trial by wearing a bracelet marked "KvE declined"
研究组 & 干预措施
Ketamine
Subjects in the ketamine arm will receive ketamine for sedation prior to rapid sequence intubation (RSI).
干预措施: Ketamine (Drug)
Etomidate
Subjects in the etomidate arm will receive etomidate for sedation prior to rapid sequence intubation (RSI).
干预措施: Etomidate (Drug)
结局指标
主要结局
SOFA Score
时间窗: up to 3 days
\*Maximum SOFA score within three hospital days: all patients. SOFA score is the Sequential Organ Failure Assessment. The minimum score is 0, the maximum score is 24, with higher scores indicating higher likelihood of worse outcome.
次要结局
- Mortality in Sepsis and Septic Shock(30 Days)
- Number of Patients With First-pass Success(up to 5 minutes (average time frame))
- Number of Patients With Post-intubation Hypoxemia(up to 2 hours)
- Peak and Plateau Pressure(up to 30 minutes (average time frame))
- Mortality(30 Days or Discharge)
- Doses of Post-intubation Sedation(up to 6 hours)
- Number of Patients With Hypotension(up to 6 hours)