Bougie or Stylet In Patients Undergoing Intubation Emergently (BOUGIE) (BOUGIE)

• ClinicalTrials.gov Identifier: NCT03928925
• Recruitment Status: Completed
• First Posted: April 26, 2019
• Last Update Posted: March 22, 2021
• Sponsor: Vanderbilt University Medical Center
• Information provided by (Responsible Party): Jonathan Casey, Vanderbilt University Medical Center

Tracking Information

• First Submitted Date: April 19, 2019
• First Posted Date: April 26, 2019
• Last Update Posted Date: March 22, 2021
• Actual Study Start Date: April 29, 2019
• Actual Primary Completion Date: February 14, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 23, 2019)

Number of intubations with successful intubation on the first attempt [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 23, 2019)

Number of intubations with severe hypoxemia [ Time Frame: 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

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: December 9, 2020)

• Cormack-Lehane grade of glottic view on first attempt [ Time Frame: from induction to 2 minutes following tracheal intubation ]
  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
• Number of laryngoscopy attempts [ Time Frame: from induction to 2 minutes following tracheal intubation ]
• Number of attempts at passing bougie [ Time Frame: from induction to 2 minutes following tracheal intubation ]
• Number of attempts at passing endotracheal tube [ Time Frame: from induction to 2 minutes following tracheal intubation ]
• Duration of intubation [ Time Frame: from the first of induction or initiation of laryngoscopy to 2 minutes following tracheal 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.
• Use of video laryngoscope screen [ Time Frame: from induction to 2 minutes following tracheal intubation ]
  Operator report of use of video laryngoscope screen on first attempt among intubations where the operator used a video laryngoscope
• Number of intubations with esophageal intubation [ Time Frame: from induction to 2 minutes following tracheal intubation ]
  Operator report of whether or not an esophageal intubation occurred
• Number of intubations with operator-reported aspiration [ Time Frame: from induction to 2 minutes following tracheal intubation ]
  Operator report of whether or not an an aspiration event occurred
• Number of intubations with airway trauma [ Time Frame: from induction to 2 minutes following tracheal intubation ]
  Operator report of whether or not airway trauma occurred
• Number of intubations with cardiac arrest within 1 hour following intubation [ Time Frame: within 1 hour following intubation ]
• Number of intubations with peri-intubation cardiovascular collapse [ Time Frame: within 1 hour following intubation ]
  Defined as any of:

  1. New systolic blood pressure < 65 mmHg between induction and 2 minutes following intubation
  2. New or increased vasopressor between induction and 2 minutes following intubation
  3. Cardiac arrest within 1 hour following intubation
  4. Death within 1 hour following intubation
• The number of ICU-free days, for each intubation, in the first 28 days [ Time Frame: 28 days ]
• The number of ventilator free days, for each intubation, in the first 28 days [ Time Frame: 28 days ]
• The number of patients who experience all-cause in-hospital mortality [ Time Frame: 28 days ]

Original Other Pre-specified Outcome Measures (submitted: April 23, 2019)

• Cormack-Lehane grade of glottic view on first attempt [ Time Frame: from induction to 2 minutes following tracheal intubation ]
  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
• Number of laryngoscopy attempts [ Time Frame: from induction to 2 minutes following tracheal intubation ]
• Number of attempts at passing bougie [ Time Frame: from induction to 2 minutes following tracheal intubation ]
• Number of attempts at passing endotracheal tube [ Time Frame: from induction to 2 minutes following tracheal intubation ]
• Time from induction to intubation [ Time Frame: from induction to 2 minutes following tracheal intubation ]
• Operator-assessed difficulty of intubation (easy, moderate, or difficult) [ Time Frame: from induction to 2 minutes following tracheal intubation ]
  Operator-reported difficulty will be reported by the operator immediately following intubation as one of three values on a three-point ordinal scale with 1 (easy) being the best score and 3 (difficult) being the worse score:

  1. easy
  2. moderate
  3. difficult
• Use of video laryngoscope screen [ Time Frame: from induction to 2 minutes following tracheal intubation ]
  Operator report of use of video laryngoscope screen on first attempt, regardless of device type
• Number of intubations with esophageal intubation [ Time Frame: from induction to 2 minutes following tracheal intubation ]
  Operator report of whether or not an esophageal intubation occurred
• Number of intubations with operator-reported aspiration [ Time Frame: from induction to 2 minutes following tracheal intubation ]
  Operator report of whether or not an an aspiration event occurred
• Number of intubations with airway trauma [ Time Frame: from induction to 2 minutes following tracheal intubation ]
  Operator report of whether or not airway trauma occurred
• Number of intubations with cardiac arrest within 1 hour following intubation [ Time Frame: within 1 hour following intubation ]
• Number of intubations with peri-intubation cardiovascular collapse [ Time Frame: within 1 hour following intubation ]
  Defined as any of:

  1. New systolic blood pressure < 65 mmHg between induction and 2 minutes following intubation
  2. New or increased vasopressor between induction and 2 minutes following intubation
  3. Cardiac arrest within 1 hour following intubation
  4. Death within 1 hour following intubation
• The number of ICU-free days, for each intubation, in the first 28 days [ Time Frame: 28 days ]
• The number of ventilator free days, for each intubation, in the first 28 days [ Time Frame: 28 days ]
• The number of patients who experience all-cause in-hospital mortality [ Time Frame: 28 days ]

Descriptive Information

• Brief Title: 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

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%)

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Acute Respiratory Failure

Intervention

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

Study Arms

• Active Comparator: 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.

  Intervention: Other: Bougie
• Active Comparator: 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.

  Intervention: Other: Endotracheal Tube with Stylet

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 23, 2019): 1106
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 13, 2021
• Actual Primary Completion Date: February 14, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03928925
• Other Study ID Numbers: 182123
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: Yes

• Responsible Party: Jonathan Casey, Vanderbilt University Medical Center
• Study Sponsor: Vanderbilt University Medical Center
• Collaborators: Not Provided

Investigators

• Study Director: Jonathan D Casey, MD; Vanderbilt University Medical Center
• Study Chair: Matthew W Semler, MD, MSc; Vanderbilt University Medical Center
• Principal Investigator: Brian E Driver, MD; Hennepin County Medical Center, Minneapolis
• Principal Investigator: Matthew E Prekker, MD; Hennepin County Medical Center, Minneapolis

• PRS Account: Vanderbilt University Medical Center
• Verification Date: March 2021