Clinical trial NCT03420950: Drug Order for Rapid Sequence Intubation
Official title: Drug Order for Rapid Sequence Intubation in Emergency Department Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Failure
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a randomized, blinded trial comparing the order of drug administration for rapid sequence intubation in the Emergency Department.

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Time elapsed from drug administration to intubation attempt end
timeFrame: 5 minutes
Secondary outcomes:
measure: Duration of first intubation attempt
timeFrame: 5 minutes
measure: Hypoxemia
timeFrame: 5 minutes
measure: Best laryngeal view
timeFrame: 5 minutes
measure: Best laryngeal view
timeFrame: 5 minutes
measure: First intubation attempt success
timeFrame: 5 minutes
Other outcomes:
measure: Memory of intubation
timeFrame: 1 week (approximately)
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin County Medical Center, Minneapolis
name: Brian Driver, MD
role: PRINCIPAL_INVESTIGATOR
References: