Artificial Intelligence-Assisted Ultrasound Assessment of Laryngeal Mask Airway Placement

NCT07766382 | Recruiting

• 1 other identifier: 2026/177
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Management

Keywords

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

Outcome Measures

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).

  During the intraoperative assessment following LMA insertion, approximately within 15 minutes after placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duzce University: lead

Study Sites (1)

Duzce University

Düzce, Düzce, Turkey (Türkiye)

RECRUITING

Central Study Contacts

gizem demir şenoğlu, ass. prof

CONTACT

05059313588; gizemsenoglu@duzce.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass.Prof

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 14, 2026
• Study Start: August 10, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 15, 2027
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)