The Articulated Oral Airway as an Aid to Mask Ventilation

• ClinicalTrials.gov Identifier: NCT03144089
• Recruitment Status: Completed
• First Posted: May 8, 2017
• Results First Posted: July 23, 2021
• Last Update Posted: July 23, 2021
• Sponsor: Ron Abrons
• Information provided by (Responsible Party): Ron Abrons, University of Iowa

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Mask Ventilation; Airway Obstruction Upper; Airway Management	Device: Articulated Oral Airway; Device: Guedel oral airway (active comparator)	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Prospective, randomized, crossover design. All patients will receive both interventions during a single anesthetic, with the order of intervention being randomized.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Anesthesia facemasks will be opacified so that the clinical provider will be blinded to which oral airway (Guedel vs AOA) is being used and in what order. The patient will be anesthetized and thus blinded. The Investigator and Outcomes Assessor will only see video of the data on the anesthesia monitor (not the patient/device/etc) and will thus be blinded. The only individuals who will not be blinded are the Research Assistants who will not be involved in data analysis.
• Primary Purpose: Treatment
• Official Title: The Articulated Oral Airway as an Aid to Mask Ventilation, a Prospective Interventional, Non-Inferiority Study
• Actual Study Start Date: July 11, 2017
• Actual Primary Completion Date: February 25, 2019
• Actual Study Completion Date: February 25, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Guedel oral airway; 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.	Device: 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.
Experimental: Articulated Oral Airway; 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.	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.; Other Names: AOA; Abrons AOA; Abrons Articulated Oral Airway

Outcome Measures

Primary Outcome Measures :

1. Expiratory Tidal Volume (Breaths 6-10) [ Time Frame: Measured immediately after placement of each oral airway; an average of 2-5 minutes. ]

   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

Secondary Outcome Measures :

1. Inspiratory Tidal Volume (Breaths 6-10) [ Time Frame: Measured immediately after placement of each oral airway; an average of 2-5 minutes. ]

   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

2. Immediate Oropharyngeal Trauma From Oral Airway Randomized to be Placed First [ Time Frame: Measured immediately after removal of first oral airway and before placing the second oral airway ]
   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..

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Iowa

The University of Iowa Hospital

Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

Ron Abrons

Investigators

• Principal Investigator: Ron O Abrons, MD; The University of Iowa Hospitals and Clinics

  Study Documents (Full-Text)

Documents provided by Ron Abrons, University of Iowa:

Study Protocol and Statistical Analysis Plan  [PDF] May 16, 2021

Informed Consent Form  [PDF] May 16, 2021

More Information

Publications:

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Ron Abrons, Assistant Professor of Anesthesiology, University of Iowa
• ClinicalTrials.gov Identifier: NCT03144089
• Other Study ID Numbers: 201704829
• First Posted: May 8, 2017
• Results First Posted: July 23, 2021
• Last Update Posted: July 23, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Ron Abrons, University of Iowa:

Morbid obesity; Obstructive sleep apnea; Mask ventilation; Upper airway obstruction

Additional relevant MeSH terms:

Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases