Bougie Use in Emergency Airway Management (BEAM)

• 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: Hennepin Healthcare Research Institute
• Information provided by (Responsible Party): Brian Driver, Hennepin Healthcare Research Institute

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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:

Study Protocol and Statistical Analysis Plan  [PDF] May 18, 2016

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• Results First Posted: June 11, 2019
• Last Update Posted: June 11, 2019
• Last Verified: May 2019

Additional relevant MeSH terms:

Respiratory Insufficiency; Emergencies; Disease Attributes; Pathologic Processes; Respiration Disorders; Respiratory Tract Diseases