NCT02902146

Bougie Use in Emergency Airway Management

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 757 (actual)
• Sponsor: Hennepin Healthcare Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Acute Respiratory Failure

Interventions

Type	Name	Description
DEVICE	Bougie
DEVICE	Endotracheal tube

Timeline

• Start date: 2016-09-27
• Primary completion: 2017-08-20
• Completion: 2017-08-20
• First posted: 2016-09-15
• Last updated: 2019-06-11
• Results posted: 2019-06-11

Locations

1 site across 1 country: United States