N/A Completed N=56 Randomized Quadruple-blind Treatment

The Articulated Oral Airway as an Aid to Mask Ventilation

Mask Ventilation · Airway Obstruction Upper · Airway Management

Source: ClinicalTrials.gov NCT03144089 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2021

Primary outcomePrimary: Expiratory Tidal Volume (Breaths 6-10) — 4.46; 3.21; 3.12; 3.48 ml/kg

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Expiratory Tidal Volume (Breaths 6-10)	4.46; 3.21; 3.12; 3.48	—
SECONDARY Inspiratory Tidal Volume (Breaths 6-10)	6.37; 5.7; 5.83; 6.72	—
SECONDARY Immediate Oropharyngeal Trauma From Oral Airway Randomized to be Placed First	3; 0	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03144089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.