The Articulated Oral Airway as an aid to mask ventilation: a prospective, randomized, interventional, non-inferiority study

Ron O Abrons,Isaac D Sheffield,Patrick Ten Eyck

doi:10.1186/s12871-021-01315-8

Abstract

BackgroundOropharyngeal airways are used both to facilitate airway patency during mask ventilation as well as conduits for flexible scope intubation, though none excel at both. A novel device, the Articulated Oral Airway (AOA), is designed to facilitate flexible scope intubation by active displacement of the tongue. Whether this active tongue displacement also facilitates mask ventilation, thus adding dual functionality, is unknown. This study compared the AOA to the Guedel Oral Airway (GOA) in regards to efficacy of mask ventilation of patients with factors predictive of difficult mask ventilation. The hypothesis was that the AOA would be non-inferior to the GOA in terms of expiratory tidal volumes by a margin of 1 ml/kg, thus demonstrating dual functionality.MethodsIn this randomized controlled clinical trial, fifty-eight patients with factors predictive of difficult mask ventilation were mask ventilated with both the GOA and the AOA. Video of the anesthetic monitors were evaluated by a blinded member of the research team, noting inspiratory and expiratory tidal volumes and expiratory CO2 waveforms.ResultsThe AOA was found to be non-inferior to the GOA at a margin of 1 ml/kg with a mean weight-standardized expiratory tidal measurement 0.45 ml/kg lower (CI: 0.34–0.57) and inspiratory tidal measurement 0.109 lower (CI: − 0.26-0.04). There was no significant difference in expiratory waveforms (p = 0.2639).ConclusionsThe AOA was non-inferior to the GOA for mask ventilation of patients with predictors of difficult mask ventilation and there was no significant difference in EtCO2 waveforms between the groups. These results were consistent in the subset of patients who were initially difficult to mask ventilate.Trial registrationClinicalTrials.gov, NCT03144089, May 2017.

Highlights

Oropharyngeal airways are used both to facilitate airway patency during mask ventilation as well as conduits for flexible scope intubation, though none excel at both
The Guedel Oral Airway (GOA) is a commonly used device that acts as a static oropharyngeal stent and can result in greater airway patency and improved mask ventilation
The Articulated Oral Airway (AOA, Fig. 1) is a novel, commercially available, injection molded oral airway designed to facilitate flexible scope intubation via active displacement of the tongue (Fig. 1b) with the added benefit of easy post-intubation removal from the mouth via disarticulation (Fig. 1c). Via this active tongue displacement, the AOA has the potential advantage of increasing the cross-sectional area for mask ventilation

Summary

Introduction

Oropharyngeal airways are used both to facilitate airway patency during mask ventilation as well as conduits for flexible scope intubation, though none excel at both. The Articulated Oral Airway (AOA, Fig. 1) is a novel, commercially available, injection molded oral airway designed to facilitate flexible scope intubation via active displacement of the tongue (Fig. 1b) with the added benefit of easy post-intubation removal from the mouth via disarticulation (Fig. 1c). Via this active tongue displacement, the AOA has the potential advantage of increasing the cross-sectional area for mask ventilation. We conducted a prospective, randomized trial comparing the efficacy of the GOA and AOA for mask ventilation of patients with factors predictive of difficult mask ventilation, with the hypothesis that the AOA would be non-inferior in regards to expiratory tidal volume. All non-tidal volume measure comparisons between GOA and AOA look for differences

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