ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03144089
Previous Study | Return to List | Next Study

The Articulated Oral Airway as an Aid to Mask Ventilation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03144089
Recruitment Status : Recruiting
First Posted : May 8, 2017
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Ron Abrons, University of Iowa

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 Type : Interventional  (Clinical Trial)
Estimated 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 (Geudel vs AOA) is being used and in what order. The patient will be anesthetised 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
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : February 1, 2019

Arm Intervention/treatment
Active Comparator: Guedel oral airway placed first
This group is randomized to receive the Guedel oral airway first and the Articulated Oral Airway second
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. When randomized to be placed first, the AOA will be inserted and evaluated first, followed by the Guedel oral airway.
Other Name: AOA, Abrons AOA, Abrons Articulated Oral Airway

Device: Guedel oral airway (active comparator)
The Guedel oral airway is a standard oral airway commonly used to facilitate mask ventilation. When randomized to be placed first, the Guedel oral airway will be inserted and evaluated first, followed by the Articulating Oral Airway (AOA).

Experimental: Articulated Oral Airway placed first
This group is randomized to receive the Articulated Oral Airway first and the Guedel oral airway second
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. When randomized to be placed first, the AOA will be inserted and evaluated first, followed by the Guedel oral airway.
Other Name: AOA, Abrons AOA, Abrons Articulated Oral Airway

Device: Guedel oral airway (active comparator)
The Guedel oral airway is a standard oral airway commonly used to facilitate mask ventilation. When randomized to be placed first, the Guedel oral airway will be inserted and evaluated first, followed by the Articulating Oral Airway (AOA).




Primary Outcome Measures :
  1. Expiratory Tidal Volume (breaths 6-10) [ Time Frame: Measured immediately after placement of each oral airway ]
    Measured expiratory tidal volume (from video of anesthestic monitor) during breaths number 6-10 with each oral airway


Secondary Outcome Measures :
  1. Inspiratory tidal volume (breaths 6-10) [ Time Frame: Measured immediately after placement of each oral airway ]
    Measured inspiratory tidal volume (from video of anesthetic monitor) during breaths number 6-10 with each oral airway

  2. Immediate oropharyngeal trauma from oral airway randomized to be placed first [ Time Frame: Measured immediately after removal of first oral airway ]
    Presence of blood (Yes or No) on first oral airway



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03144089


Contacts
Contact: Ron O Abrons, MD (319)353-8402 ron-abrons@uiowa.edu

Locations
United States, Iowa
The University of Iowa Hospital Recruiting
Iowa City, Iowa, United States, 52242
Contact: Ron Abrons, MD    319-353-8402    ron-abrons@uiowa.edu   
Sponsors and Collaborators
Ron Abrons
Investigators
Principal Investigator: Ron O Abrons, MD The University of Iowa Hospitals and Clinics

Publications:
Responsible Party: Ron Abrons, Assistant Professor of Anesthesiology, University of Iowa
ClinicalTrials.gov Identifier: NCT03144089     History of Changes
Other Study ID Numbers: 201704829
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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