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Preoperative Airway Images for Difficult Airway Prediction (AI-AIRWAY)

7 juillet 2026 mis à jour par: Murat Ferhat Ferhatoğlu, Memorial Atasehir Hospital

Multimodal Artificial Intelligence for Image-Based Prediction of Difficult Airway: A Prospective Observational Study

This prospective observational study will evaluate whether commonly available multimodal artificial intelligence models can predict difficult laryngoscopy and difficult intubation using standardized preoperative airway photographs. Adult patients scheduled for elective surgery requiring endotracheal intubation will undergo an eight-view preoperative airway photography protocol. The anonymized image sets will be assessed by ChatGPT, Gemini, and Grok using the same structured prompt. Their predictions will be compared with expert anesthesiologist image-based assessments, conventional airway evaluation findings, and prospectively recorded intraoperative airway outcomes. The primary aim is to determine the diagnostic performance of AI models for predicting difficult intubation. A key secondary aim is to evaluate their performance for predicting difficult laryngoscopy. The study is intended to explore whether image-based AI assessment may support preoperative airway risk stratification as a clinician-supervised screening tool.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Description détaillée

Preoperative airway assessment is important for identifying patients at risk for difficult laryngoscopy or difficult intubation. However, conventional bedside airway predictors have limited accuracy when used alone. Multimodal artificial intelligence models may provide additional image-based information by evaluating visible anatomical features from standardized preoperative airway photographs.

In this prospective observational study, adult patients undergoing elective surgery requiring endotracheal intubation will be enrolled between June and September 2026. Each participant will undergo standardized eight-view airway photography during the pre-anesthetic evaluation. The image set will include frontal facial, lateral profile, maximal mouth opening, modified Mallampati, neck extension, and anterior neck views. Images will be anonymized before assessment.

The same image sets will be independently evaluated by multimodal AI models, including ChatGPT, Gemini, and Grok, using an identical structured prompt. The AI models will provide categorical and binary predictions for difficult laryngoscopy and difficult intubation based only on visible image-based anatomical features. No intraoperative outcome data, expert predictions, or conventional airway assessment results will be provided to the AI models.

AI-generated predictions will be compared with expert anesthesiologist image-based assessments, conventional airway evaluation parameters, and prospectively recorded intraoperative reference outcomes. Difficult laryngoscopy will be defined as Cormack-Lehane grade III or IV. Difficult intubation will be defined using objective intraoperative criteria, including more than one intubation attempt, need for bougie or stylet assistance, rescue use of video laryngoscopy or supraglottic airway device, intubation time exceeding 60 seconds, or Intubation Difficulty Scale score greater than 5.

The study will assess the sensitivity, specificity, positive predictive value, negative predictive value, accuracy, receiver operating characteristic performance, and agreement between AI models and expert anesthesiologist assessments. The findings may help clarify whether multimodal AI can serve as a clinician-supervised adjunct for preoperative difficult airway risk stratification.

Type d'étude

Observationnel

Inscription (Estimé)

319

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Kadıköy
      • Istanbul, Kadıköy, Turquie (Türkiye), 34734
        • Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Adult patients scheduled for elective surgical procedures requiring endotracheal intubation at Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital.

La description

Inclusion Criteria:

  • Age 18 years or older
  • Scheduled for elective surgery requiring endotracheal intubation
  • Able to cooperate with the standardized preoperative airway photography protocol
  • Able to provide written informed consent

Exclusion Criteria:

  • Age younger than 18 years
  • Emergency surgery
  • Refusal or inability to provide informed consent
  • Inability to cooperate with the standardized photographic protocol
  • Known craniofacial or cervical deformity
  • History of major head and neck surgery or radiotherapy
  • Obstruction of key anatomical landmarks by facial hair, dressings, cervical collars, or other external devices
  • Incomplete or poor-quality image sets despite repeated acquisition
  • Missing clinical airway assessment data
  • No endotracheal intubation performed
  • Airway difficulty could not be reliably evaluated
  • Planned awake fiberoptic intubation or other preplanned advanced airway technique because of known difficult airway

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Elective Surgery Patients Requiring Endotracheal Intubation
Adult patients scheduled for elective surgery requiring endotracheal intubation who will undergo standardized preoperative airway photography and prospective intraoperative airway outcome recording.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Diagnostic Performance of Multimodal AI Models for Predicting Difficult Intubation
Délai: From preoperative airway photography to completion of intraoperative endotracheal intubation, up to 1 day
The primary outcome is the diagnostic performance of multimodal artificial intelligence models for predicting true difficult intubation based on standardized preoperative airway photographs. Difficult intubation will be determined using prospectively recorded intraoperative reference criteria, including more than one intubation attempt, need for bougie or stylet assistance, rescue use of video laryngoscopy or supraglottic airway device, intubation time exceeding 60 seconds, or Intubation Difficulty Scale score greater than 5. Diagnostic performance will be assessed using sensitivity, specificity, positive predictive value, negative predictive value, accuracy, and receiver operating characteristic analysis.
From preoperative airway photography to completion of intraoperative endotracheal intubation, up to 1 day

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Diagnostic Performance of Multimodal AI Models for Predicting Difficult Laryngoscopy
Délai: From preoperative airway photography to completion of intraoperative laryngoscopy, up to 1 day
The key secondary outcome is the diagnostic performance of multimodal artificial intelligence models for predicting true difficult laryngoscopy based on standardized preoperative airway photographs. Difficult laryngoscopy will be defined as Cormack-Lehane grade III or IV recorded during intraoperative airway management. Diagnostic performance will be assessed using sensitivity, specificity, positive predictive value, negative predictive value, accuracy, and receiver operating characteristic analysis.
From preoperative airway photography to completion of intraoperative laryngoscopy, up to 1 day

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

25 juin 2026

Achèvement primaire (Estimé)

1 septembre 2026

Achèvement de l'étude (Estimé)

1 septembre 2026

Dates d'inscription aux études

Première soumission

7 juillet 2026

Première soumission répondant aux critères de contrôle qualité

7 juillet 2026

Première publication (Réel)

14 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

14 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Individual participant data will not be shared due to privacy and confidentiality considerations, particularly because the study involves preoperative airway images. De-identified aggregate data will be presented in the final analysis and publication.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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