The Articulated Oral Airway as an Aid to Mask Ventilation

NCT03144089 | Completed Results DMC FDA Device

• 1 other identifier: 201704829
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Mask Ventilation; Airway Obstruction Upper; Airway Management

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Inspiratory Tidal Volume (Breaths 6-10)

  Measured immediately after placement of each oral airway; an average of 2-5 minutes.

• Immediate Oropharyngeal Trauma From Oral Airway Randomized to be Placed First

  Measured immediately after removal of first oral airway and before placing the second oral airway

Study Arms (2)

Guedel oral airway

ACTIVE COMPARATOR

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)

Articulated Oral Airway

EXPERIMENTAL

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

Interventions

Articulated Oral Airway DEVICE

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.

Also known as: AOA, Abrons AOA, Abrons Articulated Oral Airway

Articulated Oral Airway

Guedel oral airway (active comparator) DEVICE

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.

Guedel oral airway

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ron Abrons: lead

Study Sites (1)

The University of Iowa Hospital

Iowa City, Iowa, 52242, United States

Location

Related Publications (5)

• 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.

  PMID: 11259887 BACKGROUND

• 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.

  PMID: 10781266 BACKGROUND

• 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.

  PMID: 17065880 BACKGROUND

• 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.

  PMID: 19293691 BACKGROUND

• 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.

  PMID: 33781212 DERIVED

MeSH Terms

Conditions

Obesity, Morbid; Sleep Apnea, Obstructive; Airway Obstruction

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Insufficiency

Results Point of Contact

• Title: Ron Abrons, MD
• Organization: University of Iowa Hospitals and Clinics

ron-abrons@uiowa.edu

(319) 353-8061

Study Officials

• Ron O Abrons, MD

  The University of Iowa Hospitals and Clinics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Model Details: Prospective, randomized, crossover design. All patients will receive both interventions during a single anesthetic, with the order of intervention being randomized.

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: May 8, 2017
• Study Start: July 11, 2017
• Primary Completion: February 25, 2019
• Study Completion: February 25, 2019
• Last Updated: July 23, 2021
• Results First Posted: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)