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Completed

NCT Number: NCT03144089

The Articulated Oral Airway as an Aid to Mask Ventilation

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: AOA, Abrons AOA, Abrons 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.

Primary outcomes

  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 outcomes

  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..

Sponsors and collaborators

Lead sponsor

Ron Abrons

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 8, 2017
Registry last updated
Jul 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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