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Completed

NCT Number: NCT03928925

Bougie or Stylet In Patients Undergoing Intubation Emergently (BOUGIE)

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.

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Key information

Conditions

Acute Respiratory Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

About this study

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%)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is located in a participating unit of an adult hospital
  • Planned procedure is tracheal intubation with sedative administration (or tracheal intubation without sedative administration during cardiac arrest)
  • Planned operator is a clinician expected to routinely perform tracheal intubation in the participating unit
  • Planned laryngoscopy device is a non-hyperangulated laryngoscope blade

Exclusion criteria

  • Patient is pregnant
  • Patient is a prisoner
  • Urgency of intubation precludes safe performance of study procedures
  • 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
  • Operator feels use of a bougie is required or contraindicated for the care of the patient
  • Operator feels use of an endotracheal tube with stylet is required or contraindicated for the care of the patient

Treatment and study plan

Bougie

Other

disposable tracheal tube introducer of approximately 70 cm in length

Endotracheal Tube with Stylet

Other

endotracheal tube preloaded with a removable, malleable stylet

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Other outcomes

  1. 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

  2. Number of laryngoscopy attempts

    Time frame: from induction to 2 minutes following tracheal intubation

  3. Number of attempts at passing bougie

    Time frame: from induction to 2 minutes following tracheal intubation

  4. Number of attempts at passing endotracheal tube

    Time frame: from induction to 2 minutes following tracheal intubation

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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

  10. Number of intubations with cardiac arrest within 1 hour following intubation

    Time frame: within 1 hour following intubation

  11. Number of intubations with peri-intubation cardiovascular collapse

    Time frame: within 1 hour following intubation

    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

  12. The number of ICU-free days, for each intubation, in the first 28 days

    Time frame: 28 days

  13. The number of ventilator free days, for each intubation, in the first 28 days

    Time frame: 28 days

  14. The number of patients who experience all-cause in-hospital mortality

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Acronym: BOUGIE

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 26, 2019
Registry last updated
Mar 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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