NCT03928925

Brief Summary

Complications are common during tracheal intubations performed outside of the operating room. Successful intubation on the first attempt has been associated with a lower rate of procedural complications, but the proportion of critically ill patients intubated on the first attempt during tracheal intubations outside of the operating room is less than 90%. The bougie, a thin semi-rigid tube that can be placed into the trachea, allowing a Seldinger-like technique of intubating a patient's airway, has been traditionally reserved for difficult or failed airways. However, a recent single center trial of adult patients intubated in an emergency department demonstrated that use of the bougie on the first attempt improved intubation success, compared to use of a traditional stylet. Theinvestigators propose a multi-center randomized trial to compare first-attempt bougie use versus endotracheal tube with stylet use for tracheal intubation of critically ill adults in the ED and ICU.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,106

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

11 active sites

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

April 19, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 26, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

April 29, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2021

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2021

Completed
Last Updated

March 22, 2021

Status Verified

March 1, 2021

Enrollment Period

1.8 years

First QC Date

April 19, 2019

Last Update Submit

March 18, 2021

Conditions

Acute Respiratory Failure

Keywords

IntubationBougie

Outcome Measures

Primary Outcomes (1)

  • Number of intubations with successful intubation on the first attempt

    The primary outcome is successful intubation on the first attempt. Successful intubation on the first attempt is defined as placement of an endotracheal tube in the trachea (confirmed by standard means including capnography) following: (1) a single insertion of a laryngoscope blade into the mouth and (2) EITHER a single insertion of a bougie into the mouth followed by a single insertion of an endotracheal tube into the mouth OR a single insertion of an endotracheal tube with stylet into the mouth.

    from induction to 2 minutes following tracheal intubation

Secondary Outcomes (1)

  • Number of intubations with severe hypoxemia

    from induction to 2 minutes following tracheal intubation

Other Outcomes (14)

  • Cormack-Lehane grade of glottic view on first attempt

    from induction to 2 minutes following tracheal intubation

  • Number of laryngoscopy attempts

    from induction to 2 minutes following tracheal intubation

  • Number of attempts at passing bougie

    from induction to 2 minutes following tracheal intubation

  • +11 more other outcomes

Study Arms (2)

BOUGIE

ACTIVE COMPARATOR

For patients randomized to use of a bougie, the operator will use a bougie on the first attempt at intubation. If successful, an assistant will load an endotracheal tube over the bougie, and the operator (without removing the laryngoscope from the mouth) will guide the tube through the vocal cords to the desired depth in the trachea. If the bougie is not successfully placed in the trachea or the endotracheal tube cannot be successfully advanced over the bougie on the first attempt at intubation, the operator may use any approach during subsequent attempts at tracheal intubation.

Other: Bougie

Endotracheal Tube with Stylet

ACTIVE COMPARATOR

For patients randomized to use of an endotracheal tube with stylet, the operator will use an endotracheal tube containing a removeable, malleable stylet, on the first attempt at intubation. Manipulation of the shape/curve of the endotracheal tube with stylet is at the discretion of the operator, however a "straight-to-cuff" shape and a bend angle of 25° to 35° is encouraged. The stylet will be left in place until the tube is advanced to the trachea. If the endotracheal tube with stylet is not successfully placed in the trachea on the first attempt at intubation, the operator may use any approach during subsequent attempts at tracheal intubation.

Other: Endotracheal Tube with Stylet

Interventions

BougieOTHER

disposable tracheal tube introducer of approximately 70 cm in length

BOUGIE
Endotracheal Tube with StyletOTHER

endotracheal tube preloaded with a removable, malleable stylet

Endotracheal Tube with Stylet

Eligibility Criteria

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

You may qualify if:

  • Patient is located in a participating unit of an adult hospital
  • Planned procedure is tracheal intubation with sedative administration (or tracheal intubation without sedative administration during cardiac arrest)
  • Planned operator is a clinician expected to routinely perform tracheal intubation in the participating unit
  • Planned laryngoscopy device is a non-hyperangulated laryngoscope blade

You may not qualify if:

  • Patient is pregnant
  • Patient is a prisoner
  • Urgency of intubation precludes safe performance of study procedures
  • Operator feels an approach to intubation other than use of a bougie or use of an endotracheal tube with stylet would be best for the care of the patient
  • Operator feels use of a bougie is required or contraindicated for the care of the patient
  • Operator feels use of an endotracheal tube with stylet is required or contraindicated for the care of the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of Colorado

Denver, Colorado, 80045, United States

Location

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

University of Iowa Hospital

Iowa City, Iowa, 52242, United States

Location

Louisiana State University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Ochsner Medical Center | Ochsner Health System

New Orleans, Louisiana, 70112, United States

Location

Lincoln Medical Center

The Bronx, New York, 10451, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest Baptist Health

Lexington, North Carolina, 27292, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37209, United States

Location

Harborview Medical Center, University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (3)

  • 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: 29800096BACKGROUND

  • Driver BE, Semler MW, Self WH, Ginde AA, Trent SA, Gandotra S, Smith LM, Page DB, Vonderhaar DJ, West JR, Joffe AM, Mitchell SH, Doerschug KC, Hughes CG, High K, Landsperger JS, Jackson KE, Howell MP, Robison SW, Gaillard JP, Whitson MR, Barnes CM, Latimer AJ, Koppurapu VS, Alvis BD, Russell DW, Gibbs KW, Wang L, Lindsell CJ, Janz DR, Rice TW, Prekker ME, Casey JD; BOUGIE Investigators and the Pragmatic Critical Care Research Group. Effect of Use of a Bougie vs Endotracheal Tube With Stylet on Successful Intubation on the First Attempt Among Critically Ill Patients Undergoing Tracheal Intubation: A Randomized Clinical Trial. JAMA. 2021 Dec 28;326(24):2488-2497. doi: 10.1001/jama.2021.22002.

    PMID: 34879143DERIVED

  • Driver B, Semler MW, Self WH, Ginde AA, Gandotra S, Trent SA, Smith LM, Gaillard JP, Page DB, Whitson MR, Vonderhaar DJ, Joffe AM, West JR, Hughes C, Landsperger JS, Howell MP, Russell DW, Gulati S, Bentov I, Mitchell S, Latimer A, Doerschug K, Koppurapu V, Gibbs KW, Wang L, Lindsell CJ, Janz D, Rice TW, Prekker ME, Casey JD; BOUGIE Investigators# and the Pragmatic Critical Care Research Group. BOugie or stylet in patients UnderGoing Intubation Emergently (BOUGIE): protocol and statistical analysis plan for a randomised clinical trial. BMJ Open. 2021 May 25;11(5):e047790. doi: 10.1136/bmjopen-2020-047790.

    PMID: 34035106DERIVED

Study Officials

  • Jonathan D Casey, MD

    Vanderbilt University Medical Center

    STUDY DIRECTOR

  • Matthew W Semler, MD, MSc

    Vanderbilt University Medical Center

    STUDY CHAIR

  • Brian E Driver, MD

    Hennepin County Medical Center, Minneapolis

    PRINCIPAL INVESTIGATOR

  • Matthew E Prekker, MD

    Hennepin County Medical Center, Minneapolis

    PRINCIPAL INVESTIGATOR

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
Research Fellow

Study Record Dates

First Submitted

April 19, 2019

First Posted

April 26, 2019

Study Start

April 29, 2019

Primary Completion

February 14, 2021

Study Completion

March 13, 2021

Last Updated

March 22, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

Locations

US(11)