Drug Order for Rapid Sequence Intubation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

335 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-05

Study Completion Date

2021-09-29

Brief Summary

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

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Detailed Description

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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.

Conditions

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Acute Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The nurse administering the drug is not blinded, but the outcome assessor and physician performing the intubation are blinded to drug order.

Study Groups

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Sedative first

Rapid sequence intubation: sedative first

Group Type OTHER

Rapid sequence intubation: sedative first

Intervention Type OTHER

Sedative first

Paralytic agent first

Rapid sequence intubation: paralytic first

Group Type OTHER

Rapid sequence intubation: paralytic first

Intervention Type OTHER

Paralytic first

Interventions

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Rapid sequence intubation: sedative first

Sedative first

Intervention Type OTHER

Rapid sequence intubation: paralytic first

Paralytic first

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No