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Bougie Use in Emergency Airway Management (BEAM)

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ClinicalTrials.gov Identifier: NCT02902146
Recruitment Status : Completed
First Posted : September 15, 2016
Results First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Brian Driver, Hennepin Healthcare Research Institute

Brief Summary:
This prospective, open-label trial randomizes adult patients intubated in the ED with a Macintosh blade to use or not use a bougie for the first intubation attempt. The primary outcome is first pass success.

Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Device: Bougie Device: Endotracheal tube Not Applicable

Detailed Description:

The primary analysis for all outcomes will be for those with a difficult airway characteristic (defined as any of: cervical immobility, obesity, large tongue, short neck, small mandible, facial or neck trauma, airway edema, blood in the airway, or vomit in the airway).

We will also analyze all outcomes for all patients enrolled, regardless of whether they have a difficult airway characteristic.

We plan to enroll 374 patients with a difficult airway characteristic (DAC). The total enrollment for the trial will be higher, depending on the proportion of patients that have a DAC.

Based on observational data, we aim to detect a 9% absolute difference in first pass success (95% with bougie compared to 86% without the bougie), which requires enrollment of 374 patients with a DAC.

To help achieve balanced randomization for patients with a DAC, patients are stratified into two groups: 1) obese or cervical immobilization present and 2) not obese and no cervical immobilization.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 757 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bougie Use in Emergency Airway Management
Actual Study Start Date : September 27, 2016
Actual Primary Completion Date : August 20, 2017
Actual Study Completion Date : August 20, 2017

Arm Intervention/treatment
Active Comparator: Bougie
On the first intubation attempt, this arm will attempt to place a bougie into the trachea, followed by an endotracheal tube.
Device: Bougie
Active Comparator: No bougie (endotracheal tube first)
On the first intubation attempt, this arm will attempt to place an endotracheal tube into the trachea directly.
Device: Endotracheal tube



Primary Outcome Measures :
  1. Number of Participants With First Pass Success [ Time Frame: 5 minutes ]

    First pass success is defined as placement of the endotracheal tube (ETT) into the trachea on the first attempt. An attempt begins when the laryngoscope enters the mouth, and ends if either of the following occur:

    1. the laryngoscope leaves the mouth, regardless of whether an attempt was made to pass the endotracheal tube or bougie.
    2. if the operator cannot intubate the trachea with the first tube device (ETT or bougie), and switches to any other tube device, even if the laryngoscope blade remains in the mouth.

    A patient will be considered to achieve the primary outcome if they are intubated successfully on the first attempt.



Secondary Outcome Measures :
  1. First Pass Success Without Hypoxemia [ Time Frame: 5 minutes ]

    First pass success without hypoxemia. Hypoxemia is defined as a pulse oximetry value (SpO2) less than 90% at any point during intubation, or a drop of more than 10% from baseline if starting below 90%. The outcome of hypoxemia will be recorded beginning when the first attempt begins and ending one minute after inflation of the ETT cuff.

    A patient will be considered to achieve this outcome if 1) they are intubated successfully on the first attempt, and 2) do not experience hypoxemia on the first attempt.


  2. Time to Intubation (First Attempt) [ Time Frame: 5 minutes ]
    Time to intubation will be defined as the time elapsed between the beginning of the intubation attempt to inflation of the ETT cuff when the tube is in the trachea.

  3. Esophageal Intubation [ Time Frame: 5 minutes ]
    defined as passage of the ETT into the esophagus, with subsequent ventilation, and then removal. Clinically, esophageal intubation is identified by the absence of end-tidal carbon dioxide, abnormal physical exam, and hypoxia. This does not count passage of the ETT into the esophagus during the attempt if the ETT is removed during the attempt.

  4. Hypoxemia [ Time Frame: 5 minutes ]
    Hypoxemia is defined as a pulse oximetry value (SpO2) less than 90% at any point during intubation, or a drop of more than 10% from baseline if starting below 90%. The outcome of hypoxemia will be recorded beginning when the first attempt begins and ending one minute after inflation of the ETT cuff.



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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. The patient must be undergoing orotracheal intubation in the ED with a Macintosh blade (using either video or direct laryngoscopy)
  2. The patient must be presumed to be 18 years of age or older at the time of enrollment.

Exclusion Criteria:

  1. Known anatomic distortion of the upper airway or perilaryngeal structures.
  2. Prisoner or under arrest
  3. Known or suspected to be pregnant, based on the opinion of the treating physician.

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): NCT02902146


Locations
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United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Hennepin Healthcare Research Institute
  Study Documents (Full-Text)

Documents provided by Brian Driver, Hennepin Healthcare Research Institute:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brian Driver, Associate Research Director, Hennepin Healthcare Research Institute
ClinicalTrials.gov Identifier: NCT02902146    
Other Study ID Numbers: 16-4146
First Posted: September 15, 2016    Key Record Dates
Results First Posted: June 11, 2019
Last Update Posted: June 11, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Respiratory Insufficiency
Emergencies
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases