Bougie Use in Emergency Airway Management
Status: | Completed |
---|---|
Conditions: | Hospital, Hospital, Pulmonary |
Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/17/2018 |
Start Date: | September 27, 2016 |
End Date: | August 20, 2017 |
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.
Macintosh blade to use or not use a bougie for the first intubation attempt. The primary
outcome is first pass success.
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.
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.
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.
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