Bougie or Stylet In Patients Undergoing Intubation Emergently (BOUGIE)

Acute Respiratory Failure Clinical Trial

— BOUGIE  

Official title:

Bougie or Stylet In Patients Undergoing Intubation Emergently (BOUGIE): a Randomized, Multi-center Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03928925
• Other study ID #: 182123
• Status: Completed
• Phase: N/A
• Start date: April 29, 2019
• Est. completion date: March 13, 2021

Study information

• Verified date: March 2021
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1106
• Est. completion date: March 13, 2021
• Est. primary completion date: February 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• Bougie
disposable tracheal tube introducer of approximately 70 cm in length
• Endotracheal Tube with Stylet
endotracheal tube preloaded with a removable, malleable stylet

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Lincoln Medical Center	Bronx	New York
United States	Denver Health and Hospital Authority	Denver	Colorado
United States	University of Colorado	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Iowa Hospital	Iowa City	Iowa
United States	Wake Forest Baptist Health	Lexington	North Carolina
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Louisiana State University School of Medicine	New Orleans	Louisiana
United States	Ochsner Medical Center | Ochsner Health System	New Orleans	Louisiana
United States	Harborview Medical Center, University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cormack-Lehane grade of glottic view on first attempt	Grade 1: Full view of glottis Grade 2: Partial view of glottis Grade 3: Only epiglottis seen (none of glottis) Grade 4: Neither glottis nor epiglottis seen	from induction to 2 minutes following tracheal intubation
Other	Number of laryngoscopy attempts		from induction to 2 minutes following tracheal intubation
Other	Number of attempts at passing bougie		from induction to 2 minutes following tracheal intubation
Other	Number of attempts at passing endotracheal tube		from induction to 2 minutes following tracheal intubation
Other	Duration of intubation	The start of the procedure will be defined as either the time of first sedative administration or the time of initiation of laryngoscopy among patients who do not receive a sedative. The end of the procedure will be defined as the time of the final placement of an endotracheal tube within the trachea.	from the first of induction or initiation of laryngoscopy to 2 minutes following tracheal intubation
Other	Use of video laryngoscope screen	Operator report of use of video laryngoscope screen on first attempt among intubations where the operator used a video laryngoscope	from induction to 2 minutes following tracheal intubation
Other	Number of intubations with esophageal intubation	Operator report of whether or not an esophageal intubation occurred	from induction to 2 minutes following tracheal intubation
Other	Number of intubations with operator-reported aspiration	Operator report of whether or not an an aspiration event occurred	from induction to 2 minutes following tracheal intubation
Other	Number of intubations with airway trauma	Operator report of whether or not airway trauma occurred	from induction to 2 minutes following tracheal intubation
Other	Number of intubations with cardiac arrest within 1 hour following intubation		within 1 hour following intubation
Other	Number of intubations with peri-intubation cardiovascular collapse	Defined as any of: New systolic blood pressure < 65 mmHg between induction and 2 minutes following intubation; New or increased vasopressor between induction and 2 minutes following intubation; Cardiac arrest within 1 hour following intubation; Death within 1 hour following intubation	within 1 hour following intubation
Other	The number of ICU-free days, for each intubation, in the first 28 days		28 days
Other	The number of ventilator free days, for each intubation, in the first 28 days		28 days
Other	The number of patients who experience all-cause in-hospital mortality		28 days
Primary	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	Number of intubations with severe hypoxemia	Defined as an oxygen saturation less than 80% during the time interval from induction to two minutes after completion of the intubation procedure	from induction to 2 minutes following tracheal intubation