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Trial record 1 of 1 for:    NCT03144089
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The Articulated Oral Airway as an Aid to Mask Ventilation

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ClinicalTrials.gov Identifier: NCT03144089
Recruitment Status : Completed
First Posted : May 8, 2017
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Ron Abrons, University of Iowa

Tracking Information
First Submitted Date  ICMJE April 17, 2017
First Posted Date  ICMJE May 8, 2017
Last Update Posted Date April 17, 2019
Actual Study Start Date  ICMJE July 11, 2017
Actual Primary Completion Date February 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2017)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Articulated Oral Airway as an Aid to Mask Ventilation
Official Title  ICMJE The Articulated Oral Airway as an Aid to Mask Ventilation, a Prospective Interventional, Non-Inferiority Study
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Mask Ventilation
  • Airway Obstruction Upper
  • Airway Management
Intervention  ICMJE
  • 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).
Study Arms  ICMJE
  • Active Comparator: Guedel oral airway placed first
    This group is randomized to receive the Guedel oral airway first and the Articulated Oral Airway second
    Interventions:
    • Device: Articulated Oral Airway
    • Device: Guedel oral airway (active comparator)
  • Experimental: Articulated Oral Airway placed first
    This group is randomized to receive the Articulated Oral Airway first and the Guedel oral airway second
    Interventions:
    • Device: Articulated Oral Airway
    • Device: Guedel oral airway (active comparator)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2017)
58
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 25, 2019
Actual Primary Completion Date February 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03144089
Other Study ID Numbers  ICMJE 201704829
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ron Abrons, University of Iowa
Study Sponsor  ICMJE Ron Abrons
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ron O Abrons, MD The University of Iowa Hospitals and Clinics
PRS Account University of Iowa
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP