Clinical trial NCT03144089: The Articulated Oral Airway as an Aid to Mask Ventilation
Official title: The Articulated Oral Airway as an Aid to Mask Ventilation, a Prospective Interventional, Non-Inferiority Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mask Ventilation
Airway Obstruction Upper
Airway Management
Keywords: Morbid obesity
Obstructive sleep apnea
Mask ventilation
Upper airway obstruction
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective, randomized, crossover design. All patients will receive both interventions during a single anesthetic, with the order of intervention being randomized.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Expiratory Tidal Volume (Breaths 6-10)
timeFrame: Measured immediately after placement of each oral airway; an average of 2-5 minutes.
Secondary outcomes:
measure: Inspiratory Tidal Volume (Breaths 6-10)
timeFrame: Measured immediately after placement of each oral airway; an average of 2-5 minutes.
measure: Immediate Oropharyngeal Trauma From Oral Airway Randomized to be Placed First
timeFrame: Measured immediately after removal of first oral airway and before placing the second oral airway
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: The University of Iowa Hospital
state: Iowa
Study officials:
affiliation: The University of Iowa Hospitals and Clinics
name: Ron O Abrons, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koga K, Sata T, Kaku M, Takamoto K, Shigematsu A. Comparison of no airway device, the Guedel-type airway and the Cuffed Oropharyngeal Airway with mask ventilation during manual in-line stabilization. J Clin Anesth. 2001 Feb;13(1):6-10. doi: 10.1016/s0952-8180(00)00228-2.
citation: Langeron O, Masso E, Huraux C, Guggiari M, Bianchi A, Coriat P, Riou B. Prediction of difficult mask ventilation. Anesthesiology. 2000 May;92(5):1229-36. doi: 10.1097/00000542-200005000-00009.
citation: Kheterpal S, Han R, Tremper KK, Shanks A, Tait AR, O'Reilly M, Ludwig TA. Incidence and predictors of difficult and impossible mask ventilation. Anesthesiology. 2006 Nov;105(5):885-91. doi: 10.1097/00000542-200611000-00007.
citation: Kheterpal S, Martin L, Shanks AM, Tremper KK. Prediction and outcomes of impossible mask ventilation: a review of 50,000 anesthetics. Anesthesiology. 2009 Apr;110(4):891-7. doi: 10.1097/ALN.0b013e31819b5b87.
citation: Abrons RO, Ten Eyck P, Sheffield ID. The Articulated Oral Airway as an aid to mask ventilation: a prospective, randomized, interventional, non-inferiority study. BMC Anesthesiol. 2021 Mar 29;21(1):94. doi: 10.1186/s12871-021-01315-8.