Bougie or Stylet In Patients Undergoing Intubation Emergently (BOUGIE)

NCT ID: NCT03928925

Last Updated: 2021-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-29
• Study Completion Date: 2021-03-13

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.

Detailed Description

The BOUGIE trial is a prospective, parallel group, pragmatic, randomized trial comparing the effect of bougie use versus endotracheal tube with stylet use on the incidence of successful intubation on the first attempt among adults undergoing urgent or emergent tracheal intubation.

Patients admitted to the study units who are deemed by their clinical team to require intubation and fulfill inclusion criteria without meeting exclusion criteria will be randomized 1:1 to use of a bougie or use of an endotracheal tube and stylet on the first attempt at intubation. All other decisions regarding airway management, including the choice to use a bougie or endotracheal tube and stylet on subsequent attempts, will remain at the discretion of the treating provider.

The trial will enroll 1,106 patients. Conduct of the trial will be overseen by a Data Safety Monitoring Board. An interim analysis will be performed after the enrollment of 553 patients. The analysis of the trial will be conducted in accordance with a pre-specified statistical analysis plan, which will be submitted for publication or made publicly available prior to the conclusion of enrollment.

The primary outcome is successful intubation on the first attempt

The secondary outcome is severe hypoxemia (lowest arterial oxygen saturation between induction and two minutes following intubation of less than 80%)

Conditions

Acute Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BOUGIE

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.

Group Type: ACTIVE_COMPARATOR

Bougie

Intervention Type: OTHER

disposable tracheal tube introducer of approximately 70 cm in length

Endotracheal Tube with Stylet

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.

Group Type: ACTIVE_COMPARATOR

Endotracheal Tube with Stylet

Intervention Type: OTHER

endotracheal tube preloaded with a removable, malleable stylet

Interventions

Bougie

disposable tracheal tube introducer of approximately 70 cm in length

Intervention Type: OTHER

Endotracheal Tube with Stylet

endotracheal tube preloaded with a removable, malleable stylet

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patient is located in a participating unit of an adult hospital

2. Planned procedure is tracheal intubation with sedative administration (or tracheal intubation without sedative administration during cardiac arrest)

3. Planned operator is a clinician expected to routinely perform tracheal intubation in the participating unit

4. Planned laryngoscopy device is a non-hyperangulated laryngoscope blade

Exclusion Criteria

1. Patient is pregnant

2. Patient is a prisoner

3. Urgency of intubation precludes safe performance of study procedures

4. 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

5. Operator feels use of a bougie is required or contraindicated for the care of the patient

6. Operator feels use of an endotracheal tube with stylet is required or contraindicated for the care of the patient

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Casey

Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan D Casey, MD

Role: STUDY_DIRECTOR

Vanderbilt University Medical Center

Matthew W Semler, MD, MSc

Role: STUDY_CHAIR

Vanderbilt University Medical Center

Brian E Driver, MD

Role: PRINCIPAL_INVESTIGATOR

Hennepin County Medical Center, Minneapolis

Matthew E Prekker, MD

Role: PRINCIPAL_INVESTIGATOR

Hennepin County Medical Center, Minneapolis

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Colorado

Denver, Colorado, United States

Denver Health and Hospital Authority

Denver, Colorado, United States

University of Iowa Hospital

Iowa City, Iowa, United States

Louisiana State University School of Medicine

New Orleans, Louisiana, United States

Ochsner Medical Center | Ochsner Health System

New Orleans, Louisiana, United States

Lincoln Medical Center

The Bronx, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Wake Forest Baptist Health

Lexington, North Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Harborview Medical Center, University of Washington

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 29800096 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34879143 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34035106 (View on PubMed)

Other Identifiers

182123

Identifier Type: -

Identifier Source: org_study_id