Bougie Use in Emergency Airway Management (BEAM)

Hennepin Healthcare

Status: Completed

Conditions: Acute Respiratory Failure

Treatments: Device: Endotracheal tube; Device: Bougie

Study type: Interventional

Funder types: Other

Identifiers

NCT02902146

16-4146

Details and patient eligibility

About

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.

Full 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.

Enrollment: 757 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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757 participants in 2 patient groups

Bougie

Active Comparator group

Description:

On the first intubation attempt, this arm will attempt to place a bougie into the trachea, followed by an endotracheal tube.

Treatment:

Device: Bougie

No bougie (endotracheal tube first)

Active Comparator group

Description:

On the first intubation attempt, this arm will attempt to place an endotracheal tube into the trachea directly.

Treatment:

Device: Endotracheal tube