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

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ClinicalTrials.gov Identifier: NCT03928925
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Jonathan Casey, 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.


Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Other: Bougie Other: Endotracheal Tube with Stylet Not Applicable

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%)


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bougie or Stylet In Patients Undergoing Intubation Emergently (BOUGIE): a Randomized, Multi-center Trial
Actual Study Start Date : April 29, 2019
Estimated Primary Completion Date : October 22, 2020
Estimated Study Completion Date : April 22, 2021

Arm Intervention/treatment
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.

Other: Bougie
disposable tracheal tube introducer of approximately 70 cm in length

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.

Other: Endotracheal Tube with Stylet
endotracheal tube preloaded with a removable, malleable stylet




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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. Time from induction to intubation [ Time Frame: from induction to 2 minutes following tracheal intubation ]
  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. Number of intubations with cardiac arrest within 1 hour following intubation [ Time Frame: within 1 hour following intubation ]
  12. 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

  13. The number of ICU-free days, for each intubation, in the first 28 days [ Time Frame: 28 days ]
  14. The number of ventilator free days, for each intubation, in the first 28 days [ Time Frame: 28 days ]
  15. The number of patients who experience all-cause in-hospital mortality [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is at least 18 years old
  2. Patient is located in a participating unit
  3. Planned procedure is tracheal intubation with sedative administration (or tracheal intubation without sedative administration during cardiac arrest)
  4. Planned operator is a clinician expected to routinely perform tracheal intubation in the participating unit
  5. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928925


Contacts
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Contact: Jonathan D Casey, MD (615) 208-6139 Jonathan.d.Casey@vumc.org
Contact: Matthew W Semler, MD, MSc (615) 802-8428 Matthew.w.semler@vumc.org

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Derek W Russell, MD         
United States, Colorado
University of Colorado Recruiting
Denver, Colorado, United States, 80045
Contact: Adit Ginde       Adit.Ginde@ucdenver.edu   
Denver Health and Hospital Authority Recruiting
Denver, Colorado, United States, 80204
Contact: Stacey Trent       Stacy.Trent@dhha.org   
United States, Louisiana
Louisiana State University School of Medicine Recruiting
New Orleans, Louisiana, United States, 70112
Contact: David R Janz, MD, MSc    504-568-3167      
Ochsner Medical Center | Ochsner Health System Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Kevin M Dischert, MD         
Contact: Derek J Vonderhaar, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Vijay Krishnamoorthy       vijay.krishnamoorthy@duke.edu   
Wake Forest Baptist Health Recruiting
Lexington, North Carolina, United States, 27292
Contact: Lane M Smith, MD, PhD       lmsmith@wakehealth.edu   
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37209
Contact: Jonathan D Casey, MD    615-322-3412    Jonathan.d.Casey@vumc.org   
Contact: Matthew W Semler, MD, MSc    615-802-8428    matthew.w.semler@vanderbilt.edu   
Principal Investigator: Wesley H. Self, MD         
United States, Washington
Harborview Medical Center, University of Washington Not yet recruiting
Seattle, Washington, United States, 98104
Contact: Aaron M Joffe, DO         
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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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

Publications:
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Responsible Party: Jonathan Casey, Research Fellow, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03928925     History of Changes
Other Study ID Numbers: 182123
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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
Keywords provided by Jonathan Casey, Vanderbilt University Medical Center:
Intubation
Bougie
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases