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Artificial Intelligence-Assisted Ultrasound Assessment of Laryngeal Mask Airway Placement

Artificial Intelligence-Assisted Ultrasound Confirmation of Laryngeal Mask Airway Placement Using Fiberoptic Assessment as the Reference Standard: A Prospective Diagnostic Accuracy Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07766382
Enrollment
200
Registered
2026-08-14
Start date
2026-08-10
Completion date
2027-05-15
Last updated
2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Management

Keywords

Laryngeal Mask Airway, Supraglottic Airway, Airway Ultrasonography, Artificial Intelligence, Machine Learning

Brief summary

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.

Detailed description

Laryngeal mask airways are widely used for supraglottic airway management during general anesthesia. Although adequate ventilation can usually be achieved after insertion, satisfactory clinical ventilation does not necessarily indicate optimal anatomical placement. Fiberoptic assessment provides direct visualization of the relationship between the LMA and laryngeal structures but is invasive and not routinely available in all clinical settings. Airway ultrasonography provides a non-invasive bedside method for evaluating LMA position. In this prospective observational study, standardized post-placement ultrasound images will be obtained in adult patients undergoing elective surgery with an LMA. Fiberoptic assessment will subsequently be performed and graded according to the Brimacombe fiberoptic scoring system. Grades 3-4 will constitute optimal placement and grades 1-2 suboptimal placement. Three prediction approaches are planned. Model A will use prespecified clinical and quantitative ultrasound variables, including age, sex, body mass index, Mallampati class, mouth opening, thyromental distance, neck circumference, dentition status, tongue thickness, skin-to-epiglottis distance, and the hyomental distance ratio. Model B will use post-placement ultrasound images alone using a transfer-learning-based image model. Model C will integrate ultrasound image features with the prespecified tabular variables in a multimodal prediction model. Model performance will be assessed using patient-level resampling procedures. The primary performance measure will be the area under the receiver operating characteristic curve (AUROC), with additional assessment of sensitivity, specificity, positive and negative predictive values, F1 score, precision-recall performance, and calibration. Images obtained from the same participant will remain within the same data partition to prevent information leakage

Interventions

None listed

Sponsors

Duzce University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Discrimination of Optimal Versus Suboptimal LMA Placement by the Multimodal Artificial Intelligence ModelDuring the intraoperative assessment following LMA insertion, approximately within 15 minutes after placementThe 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).

Countries

Turkey (Türkiye)

Contacts

CONTACTgizem demir şenoğlu, ass. prof
gizemsenoglu@duzce.edu.tr05059313588

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026