An observational study in Airway Management, sponsored by Duzce University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Duzce University · Observational
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.
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
Duzce University is the lead sponsor of 76 studies on the registry; 11 are open to participants now.
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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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 placement
Plan to share: No
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Duzce University