Bougie Use in Emergency Airway Management (BEAM)

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Failure
• Intervention / Treatment: Device: Endotracheal tube; Device: Bougie

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.

• Study Type: Interventional
• Enrollment (Actual): 757
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With First Pass Success	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: the laryngoscope leaves the mouth, regardless of whether an attempt was made to pass the endotracheal tube or bougie.; 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.	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First Pass Success Without Hypoxemia	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.	5 minutes
Time to Intubation (First Attempt)	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.	5 minutes
Esophageal Intubation	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.	5 minutes
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.	5 minutes

Collaborators and Investigators

• Sponsor: Hennepin Healthcare Research Institute

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2016
• Primary Completion (Actual): August 20, 2017
• Study Completion (Actual): August 20, 2017

Study Registration Dates

• First Submitted: September 12, 2016
• First Submitted That Met QC Criteria: September 12, 2016
• First Posted (Estimate): September 15, 2016

Study Record Updates

• Last Update Posted (Actual): June 11, 2019
• Last Update Submitted That Met QC Criteria: May 21, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Emergencies; Respiratory Insufficiency
• Other Study ID Numbers: 16-4146