The Articulated Oral Airway as an Aid to Mask Ventilation

NCT03144089 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2021-07-23

Study results available
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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

Interventions

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.

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.

Sponsors & Collaborators

  • Ron Abrons

    lead OTHER

Principal Investigators

  • Ron O Abrons, MD · The University of Iowa Hospitals and Clinics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-11
Primary Completion
2019-02-25
Completion
2019-02-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03144089 on ClinicalTrials.gov