Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
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. Read our disclaimer for details.
 
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:
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.

Layout table for study information
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

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




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..



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.


Layout table for eligibility information
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


Locations
Layout table for location information
United States, Iowa
The University of Iowa Hospital
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Ron Abrons
Investigators
Layout table for investigator information
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:
Informed Consent Form  [PDF] May 16, 2021

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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    Key Record Dates
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

Layout table for additional information
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:
Layout table for MeSH terms
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases