N/A
N=56
The Articulated Oral Airway as an Aid to Mask Ventilation
Mask Ventilation · Airway Obstruction Upper · Airway Management
Bottom Line
View on ClinicalTrials.gov: NCT03144089 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Expiratory Tidal Volume (Breaths 6-10) — 4.46; 3.21; 3.12; 3.48 ml/kg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Articulated Oral Airway (Device); Guedel oral airway (active comparator) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ron Abrons
- Primary completion
- Feb 2019
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 | — |
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.
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
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.