Bougie or Stylet In Patients Undergoing Intubation Emergently (BOUGIE)

Not Applicable

Completed

• Conditions: Acute Respiratory Failure
• Interventions: Other: Endotracheal Tube with Stylet; Other: Bougie

• Registration Number: NCT03928925
• Lead Sponsor: Vanderbilt University Medical Center

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%)

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-04-19
• Study First Submitted QC: 2019-04-23
• Study First Posted: 2019-04-26
• Study Start: 2019-04-29
• Primary Completion: 2021-02-14
• Status Verified: 2021-03
• Study Completion: 2021-03-13
• Last Update Submitted: 2021-03-18
• Last Update Posted: 2021-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1106

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endotracheal Tube with Stylet	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.
BOUGIE	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.

Primary Outcome Measures

Name	Time	Method
Number of intubations with successful intubation on the first attempt	from induction to 2 minutes following tracheal intubation	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.

Secondary Outcome Measures

Name	Time	Method
Number of intubations with severe hypoxemia	from induction to 2 minutes following tracheal intubation	Defined as an oxygen saturation less than 80% during the time interval from induction to two minutes after completion of the intubation procedure

Trial Locations

Locations (11)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Harborview Medical Center, University of Washington; 🇺🇸 Seattle, Washington, United States

University of Colorado; 🇺🇸 Denver, Colorado, United States

Ochsner Medical Center | Ochsner Health System; 🇺🇸 New Orleans, Louisiana, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Denver Health and Hospital Authority; 🇺🇸 Denver, Colorado, United States

University of Iowa Hospital; 🇺🇸 Iowa City, Iowa, United States

Lincoln Medical Center; 🇺🇸 Bronx, New York, United States

Louisiana State University School of Medicine; 🇺🇸 New Orleans, Louisiana, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Wake Forest Baptist Health; 🇺🇸 Lexington, North Carolina, United States