Drug Order for Rapid Sequence Intubation in Emergency Department Intubation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 335
- 试验地点
- 2
- 主要终点
- Time elapsed from drug administration to intubation attempt end
研究概览
简要总结
This is a randomized, blinded trial comparing the order of drug administration for rapid sequence intubation in the Emergency Department.
详细描述
Based on data (excluding outliers) from protocol 16-4146, the intubation time with the paralytic and sedative first administered is 86 s, and 93 s, respectively, with a standard deviation of approximately 25-30 s. Using these assumptions, 470 patients (235 per group) will need to be enrolled to detect an 7 s absolute difference between groups with 80% power.
Because a greater difference is anticipated in those who receive rocuronium rather than succinylcholine (because succinylcholine takes action faster), goal enrollment is 470 patients who receive rocuronium as the paralytic who are intubated successfully on the first attempt. The total enrollment will be higher, accounting for those who receive succinylcholine and those who are not successful on the first attempt. The data for those who receive succinylcholine first will be reported and is planned to be used to determine the feasibility of a future trial.
The primary group of analysis will be those receiving rocuronium, because this medication acts somewhat slower than succinylcholine. Patients who receive either drug will be analyzed, but it is pre-specified that the group of interest are those receiving rocuronium.
The primary outcome, first intubation attempt duration, and apnea duration will be measured only in those with a successful first attempt because these timing events will be confounded by attempt failure; in these cases the altered duration will have more to do with device or patient characteristics than with drug order.
The remainder of the outcomes will be measured in all enrolled subjects in an intention to treat analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The nurse administering the drug is not blinded, but the outcome assessor and physician performing the intubation are blinded to drug order.
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
- •The patient must be undergoing orotracheal intubation in the Emergency Department
- •The patient must be receiving both a sedative and paralytic immediately prior to intubation (i.e. undergoing rapid sequence intubation).
- •The patient must be presumed to be 18 years of age or older at the time of enrollment.
排除标准
- •Prisoner or in custody
- •Known or suspected to be pregnant, based on the opinion of the attending physician.
- •Intubation performed by a physician assistant (this is rarely done in our ED; each physician assistant intubates less than twice per year, so the intubation outcomes would hinge more on their experience rather than drug order).
结局指标
主要结局
Time elapsed from drug administration to intubation attempt end
时间窗: 5 minutes
The primary outcome will be time from complete administration of the first medication to successful first attempt intubation. This timing period will begin when the first RSI agent is completely administered and end when the laryngoscope blade is removed from the mouth. Attempts that are not successful on the first attempt will be excluded from the primary outcome measure because the time to intubation will be confounded by the failure; in these cases the altered duration will have more to do with device or patient characteristics than with drug order.
次要结局
- Duration of first intubation attempt(5 minutes)
- Hypoxemia(5 minutes)
- First intubation attempt success(5 minutes)
- Best laryngeal view(5 minutes)
研究者
Brian Driver
Director of Clinical Research, Dept of Emergency Medicine
Hennepin Healthcare Research Institute