NCT02902146

Brief Summary

This prospective, open-label trial randomizes adult patients intubated in the ED with a Macintosh blade to use or not use a bougie for the first intubation attempt. The primary outcome is first pass success.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
757

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
12 days until next milestone

Study Start

First participant enrolled

September 27, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2017

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

June 11, 2019

Completed
Last Updated

June 11, 2019

Status Verified

May 1, 2019

Enrollment Period

11 months

First QC Date

September 12, 2016

Results QC Date

April 29, 2019

Last Update Submit

May 21, 2019

Conditions

Acute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With First Pass Success

    First pass success is defined as placement of the endotracheal tube (ETT) into the trachea on the first attempt. An attempt begins when the laryngoscope enters the mouth, and ends if either of the following occur: 1. the laryngoscope leaves the mouth, regardless of whether an attempt was made to pass the endotracheal tube or bougie. 2. if the operator cannot intubate the trachea with the first tube device (ETT or bougie), and switches to any other tube device, even if the laryngoscope blade remains in the mouth. A patient will be considered to achieve the primary outcome if they are intubated successfully on the first attempt.

    5 minutes

Secondary Outcomes (4)

  • First Pass Success Without Hypoxemia

    5 minutes

  • Time to Intubation (First Attempt)

    5 minutes

  • Esophageal Intubation

    5 minutes

  • Hypoxemia

    5 minutes

Study Arms (2)

Bougie

ACTIVE COMPARATOR

On the first intubation attempt, this arm will attempt to place a bougie into the trachea, followed by an endotracheal tube.

Device: Bougie

No bougie (endotracheal tube first)

ACTIVE COMPARATOR

On the first intubation attempt, this arm will attempt to place an endotracheal tube into the trachea directly.

Device: Endotracheal tube

Interventions

BougieDEVICE
Bougie
Endotracheal tubeDEVICE
No bougie (endotracheal tube first)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient must be undergoing orotracheal intubation in the ED with a Macintosh blade (using either video or direct laryngoscopy)
  • The patient must be presumed to be 18 years of age or older at the time of enrollment.

You may not qualify if:

  • Known anatomic distortion of the upper airway or perilaryngeal structures.
  • Prisoner or under arrest
  • Known or suspected to be pregnant, based on the opinion of the treating physician.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (1)

  • Driver BE, Prekker ME, Klein LR, Reardon RF, Miner JR, Fagerstrom ET, Cleghorn MR, McGill JW, Cole JB. Effect of Use of a Bougie vs Endotracheal Tube and Stylet on First-Attempt Intubation Success Among Patients With Difficult Airways Undergoing Emergency Intubation: A Randomized Clinical Trial. JAMA. 2018 Jun 5;319(21):2179-2189. doi: 10.1001/jama.2018.6496.

    PMID: 29800096DERIVED

Results Point of Contact

Title
Audrey Hendrickson
Organization
HHRI
audrey.hendrickson@hcmed.org
6128737448

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Research Director

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 15, 2016

Study Start

September 27, 2016

Primary Completion

August 20, 2017

Study Completion

August 20, 2017

Last Updated

June 11, 2019

Results First Posted

June 11, 2019

Record last verified: 2019-05

Locations

US(1)