Drug Order for Rapid Sequence Intubation

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.

An analysis for patients by RSI drug order actually received, regardless of treatment
allocation, will also be presented.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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).