The Articulated Oral Airway as an Aid to Mask Ventilation

Ron Abrons

Status: Completed

Conditions: Airway Obstruction Upper; Airway Management; Mask Ventilation

Treatments: Device: Guedel oral airway (active comparator); Device: Articulated Oral Airway

Study type: Interventional

Funder types: Other

Identifiers

NCT03144089

201704829

Details and patient eligibility

About

The Articulating Oral Airway (AOA) is a novel oral airway which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The investigators hypothesize that, in patients with predictors for difficult mask ventilation, the AOA will be non-inferior to the Geudel oral airway in terms of expired tidal volumes.

Full description

Difficult mask ventilation (MV) is common in the obese population and can result in patient morbidity and mortality. The Articulating Oral Airway (AOA) is a novel oral airway which actively displaces the tongue, allowing for a greater cross-sectional area for MV. The investigators hypothesize that, while using the same ventilatory pressure in neuromuscularly blocked patients with predictors for difficult mask ventilation, MV with an AOA will not result in smaller expired tidal volumes than MV with a similarly sized Guedel oral airway (GDA). In other words, the AOA will be non-inferior to the GDA in terms of expired tidal volumes.

Enrollment: 58 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Individuals demonstrating 2 or greater predictors of difficult mask ventilation (as listed below) who are scheduled for elective surgery with general anesthesia and asleep mask ventilation/orotracheal intubation utilizing long-acting neuromuscular blockade.
• Predictors of difficult mask ventilation i) Age > 55 years ii) BMI > 30kg/m2 iii) Beard iv) Lack of teeth v) History of snoring

Exclusion criteria

• Documented history of impossible mask ventilation
• Planned omission of mask ventilation ('rapid-sequence induction,' etc.)
• Planned omission of long-acting paralytics
• Need for awake airway management
• Need for emergent airway protection
• Presence of oropharyngeal anatomic abnormalities
• Distance from the maxillary incisors to the angle of the mandible <11cm
• <18 years of age
• Known pregnant state
• Current incarceration
• Refusal to be involved in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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58 participants in 2 patient groups

Guedel oral airway

Active Comparator group

Description:

Each participant in the study will have both devices (GOA or AOA). The participants reported in this arm were randomized to receive the Guedel oral airway first and measurements were taken during breaths 6 through 10. After its removal the Articulated Oral Airway was inserted and measurements were repeated again during breaths 6 through 10.

Treatment:

Device: Guedel oral airway (active comparator)

Articulated Oral Airway

Experimental group

Description:

Each participant in the study will have both devices (GOA or AOA). The participants reported in this arm were randomized to receive the Articulated oral airway first and measurements were taken during breaths 6 through 10. After its removal the Guedel Oral Airway was inserted and measurements were repeated again during breaths 6 through 10.

Treatment:

Device: Articulated Oral Airway