The Articulated Oral Airway as an Aid to Mask Ventilation (NCT03144089) | Clinical Trial Compass
CompletedNot Applicable
The Articulated Oral Airway as an Aid to Mask Ventilation
United States58 participantsStarted 2017-07-11
Plain-language 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.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Expiratory Tidal Volume (Breaths 6-10)
Timeframe: Measured immediately after placement of each oral airway; an average of 2-5 minutes.