Drug Order for Rapid Sequence Intubation

NCT03420950 | Completed DMC

• 1 other identifier: 17-4432
• Study Type: interventional
• Target: 335
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Duration of first intubation attempt

  5 minutes

• Hypoxemia

  5 minutes

• Best laryngeal view

  5 minutes

• Best laryngeal view

  5 minutes

• First intubation attempt success

  5 minutes

Other Outcomes (1)

• Memory of intubation

  1 week (approximately)

Study Arms (2)

Sedative first

OTHER

Rapid sequence intubation: sedative first

Other: Rapid sequence intubation: sedative first

Paralytic agent first

OTHER

Rapid sequence intubation: paralytic first

Other: Rapid sequence intubation: paralytic first

Interventions

Rapid sequence intubation: sedative first OTHER

Sedative first

Sedative first

Rapid sequence intubation: paralytic first OTHER

Paralytic first

Paralytic agent first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Study Officials

• Brian Driver, MD

  Hennepin County Medical Center, Minneapolis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The nurse administering the drug is not blinded, but the outcome assessor and physician performing the intubation are blinded to drug order.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research, Dept of Emergency Medicine

Study Record Dates

• First Submitted: January 28, 2018
• First Posted: February 5, 2018
• Study Start: February 5, 2018
• Primary Completion: September 29, 2021
• Study Completion: September 29, 2021
• Last Updated: February 3, 2022

Record last verified: 2022-01

Locations

US (1)