Drug Order for Rapid Sequence Intubation (DO-RSI)

Drug Order for Rapid Sequence Intubation in Emergency Department Intubation

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

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Failure
• Intervention / Treatment: Other: Rapid sequence intubation: sedative first; Other: Rapid sequence intubation: paralytic first

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.

• Study Type: Interventional
• Enrollment (Actual): 335
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Sedative first; Rapid sequence intubation: sedative first	Other: Rapid sequence intubation: sedative first; Sedative first
Other: Paralytic agent first; Rapid sequence intubation: paralytic first	Other: Rapid sequence intubation: paralytic first; Paralytic first

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time elapsed from drug administration to intubation attempt end	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.	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of first intubation attempt	Defined as the time elapsed between inserting and removing the laryngoscope blade from the mouth. The primary outcome, duration of the first intubation attempt, and apnea duration will only be measured in those with a successful first attempt.	5 minutes
Hypoxemia	Oxygen saturation < 90%, during the time interval between the start of the intubation attempt and 1 minute following completion of the attempt.	5 minutes
Best laryngeal view	Cormack-Lehane grade	5 minutes
Best laryngeal view	Percent of glottic opening	5 minutes
First intubation attempt success	Defined as successful intubation with a single insertion of the laryngoscope, regardless of the number of passages of the endotracheal tube or bougie.	5 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Memory of intubation	A structured questionnaire will be administered to patients after extubation. We will attempt to approach all enrolled patients, but realize that some will be unreachable due to death, head injury, rapid discharge from the hospital, and other reason.	1 week (approximately)

Collaborators and Investigators

• Sponsor: Hennepin Healthcare Research Institute
• Investigators: Principal Investigator: Brian Driver, MD, Hennepin County Medical Center, Minneapolis

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2018
• Primary Completion (Actual): September 29, 2021
• Study Completion (Actual): September 29, 2021

Study Registration Dates

• First Submitted: January 28, 2018
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: January 19, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives
• Other Study ID Numbers: 17-4432

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No