Clinical trial NCT03928925: Bougie or Stylet In Patients Undergoing Intubation Emergently (BOUGIE)
Official title: Bougie or Stylet In Patients Undergoing Intubation Emergently (BOUGIE): a Randomized, Multi-center Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Failure
Keywords: Intubation
Bougie
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 1106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%)

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

Primary outcomes:
measure: Number of intubations with successful intubation on the first attempt
timeFrame: from induction to 2 minutes following tracheal intubation
Secondary outcomes:
measure: Number of intubations with severe hypoxemia
timeFrame: from induction to 2 minutes following tracheal intubation
Other outcomes:
measure: Cormack-Lehane grade of glottic view on first attempt
timeFrame: from induction to 2 minutes following tracheal intubation
measure: Number of laryngoscopy attempts
timeFrame: from induction to 2 minutes following tracheal intubation
measure: Number of attempts at passing bougie
timeFrame: from induction to 2 minutes following tracheal intubation
measure: Number of attempts at passing endotracheal tube
timeFrame: from induction to 2 minutes following tracheal intubation
measure: Duration of intubation
timeFrame: from the first of induction or initiation of laryngoscopy to 2 minutes following tracheal intubation
measure: Use of video laryngoscope screen
timeFrame: from induction to 2 minutes following tracheal intubation
measure: Number of intubations with esophageal intubation
timeFrame: from induction to 2 minutes following tracheal intubation
measure: Number of intubations with operator-reported aspiration
timeFrame: from induction to 2 minutes following tracheal intubation
measure: Number of intubations with airway trauma
timeFrame: from induction to 2 minutes following tracheal intubation
measure: Number of intubations with cardiac arrest within 1 hour following intubation
timeFrame: within 1 hour following intubation
measure: Number of intubations with peri-intubation cardiovascular collapse
timeFrame: within 1 hour following intubation
measure: The number of ICU-free days, for each intubation, in the first 28 days
timeFrame: 28 days
measure: The number of ventilator free days, for each intubation, in the first 28 days
timeFrame: 28 days
measure: The number of patients who experience all-cause in-hospital mortality
timeFrame: 28 days
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
city: Iowa City
country: United States
facility: University of Iowa Hospital
state: Iowa
city: New Orleans
country: United States
facility: Louisiana State University School of Medicine
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center | Ochsner Health System
state: Louisiana
city: Bronx
country: United States
facility: Lincoln Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Lexington
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Seattle
country: United States
facility: Harborview Medical Center, University of Washington
state: Washington
Study officials:
affiliation: Vanderbilt University Medical Center
name: Jonathan D Casey, MD
role: STUDY_DIRECTOR
affiliation: Vanderbilt University Medical Center
name: Matthew W Semler, MD, MSc
role: STUDY_CHAIR
affiliation: Hennepin County Medical Center, Minneapolis
name: Brian E Driver, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hennepin County Medical Center, Minneapolis
name: Matthew E Prekker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.