Artificial Intelligence-Assisted Ultrasound Assessment of Laryngeal Mask Airway Placement
ConditionAirway Management
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDuzce University
About this trial
This prospective observational study aims to develop and evaluate artificial intelligence-based models for the assessment of laryngeal mask airway (LMA) placement in adult patients undergoing elective surgery under general anesthesia. Following LMA insertion, standardized airway ultrasound images will be obtained and fiberoptic assessment will be performed as the anatomical reference standard. Fiberoptic findings will be classified as optimal (Brimacombe grades 3-4) or suboptimal (grades 1-2). Clinical and quantitative airway ultrasound variables will also be recorded. The predictive performance of tabular, image-only, and multimodal artificial intelligence models will be evaluated for identifying optimal versus suboptimal LMA placement.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults undergoing elective surgery under general anesthesia in whom LMA use is clinically planned; ASA physical status I-III; ability to provide written informed consent.
Disqualifiers
Emergency surgery; pregnancy; anticipated difficult airway; major upper airway or neck anatomical abnormality or previous major neck surgery; clinically significant aspiration risk or contraindication to LMA use; inability to obtain adequate ultrasound images or fiberoptic assessment.
Trial population
Adult patients (aged 18 years or older) with ASA physical status I-III who are scheduled for elective surgery under general anesthesia and in whom a laryngeal mask airway is planned for airway management will constitute the study population. Patients will be recruited prospectively from the operating rooms of Düzce University Research and Application Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Discrimination of Optimal Versus Suboptimal LMA Placement by the Multimodal Artificial Intelligence Model
The ability of the multimodal artificial intelligence model combining post-placement ultrasound images with prespecified clinical and quantitative ultrasound variables to discriminate optimal from suboptimal LMA placement, using fiberoptic assessment as the reference standard. Optimal placement will be defined as Brimacombe grades 3-4 and suboptimal placement as grades 1-2. Model discrimination will primarily be quantified using the area under the receiver operating characteristic curve (AUROC).
Time frame
During the intraoperative assessment following LMA insertion, approximately within 15 minutes after placementSponsors and contacts
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Source ClinicalTrials.gov