The Articulated Oral Airway as an Aid to Mask Ventilation

Airway Management Clinical Trial

Official title:

The Articulated Oral Airway as an Aid to Mask Ventilation, a Prospective Interventional, Non-Inferiority Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03144089
• Other study ID #: 201704829
• Status: Completed
• Phase: N/A
• Start date: July 11, 2017
• Est. completion date: February 25, 2019

Study information

• Verified date: July 2021
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 25, 2019
• Est. primary completion date: February 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Management
• Airway Obstruction
• Airway Obstruction Upper
• Mask Ventilation

Intervention

Device:
• Articulated Oral Airway
The AOA is a novel device which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The AOA will be evaluated for efficacy of mask ventilation.
• Guedel oral airway (active comparator)
The Guedel oral airway is a standard oral airway commonly used to facilitate mask ventilation. The Guedel oral airway will be evaluated for efficacy of mask ventilation.

Locations

Country	Name	City	State
United States	The University of Iowa Hospital	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Ron Abrons

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expiratory Tidal Volume (Breaths 6-10)	Measured expiratory tidal volume (from video of anesthesia monitor). Each participant had measurements collected during breaths number 6-10 after the insertion of each oral airway (GOA or AOA) with the order of first treatment randomized. The average expiratory tidal volumes reported were weight standardized per kilogram of participant's body weight, meaning the expiratory measurements were divided by the participant's weight (kg). A total of 56 patients were enrolled and randomized--28 received the Guedel Oral Airway first and 28 received the Articulated Oral Airway first. The average expiratory values are reported as outlined in table below: Guedel inserted first AOA inserted first Guedel inserted second AOA inserted second	Measured immediately after placement of each oral airway; an average of 2-5 minutes.
Secondary	Inspiratory Tidal Volume (Breaths 6-10)	Measured inspiratory tidal volume (from video of anesthesia monitor). Each participant had measurements collected during breaths number 6-10 after the insertion of each oral airway (GOA or AOA) with the order of first treatment randomized. The average inspiratory tidal volumes reported were weight-standardized per kilogram of participant's body weight, meaning the inspiratory measurements were divided by the participant's weight (kg). A total of 56 patients were enrolled and randomized--28 received the Guedel Oral Airway first and 28 received the Articulated Oral Airway first. The average inspiratory values are reported as outlined in table below: Guedel inserted first AOA inserted first Guedel inserted second AOA inserted second	Measured immediately after placement of each oral airway; an average of 2-5 minutes.
Secondary	Immediate Oropharyngeal Trauma From Oral Airway Randomized to be Placed First	After the first oral airway device was removed, it was visually inspected for the presence of blood and is reported as the number of subjects where blood was visualized on the initial airway device..	Measured immediately after removal of first oral airway and before placing the second oral airway