- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07700485
Preoperative Airway Images for Difficult Airway Prediction (AI-AIRWAY)
Multimodal Artificial Intelligence for Image-Based Prediction of Difficult Airway: A Prospective Observational Study
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Kadıköy
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Istanbul, Kadıköy, Turquía (Türkiye), 34734
- Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Diagnostic Performance of Multimodal AI Models for Predicting Difficult Intubation
Periodo de tiempo: From preoperative airway photography to completion of intraoperative endotracheal intubation, up to 1 day
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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.
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From preoperative airway photography to completion of intraoperative endotracheal intubation, up to 1 day
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Diagnostic Performance of Multimodal AI Models for Predicting Difficult Laryngoscopy
Periodo de tiempo: From preoperative airway photography to completion of intraoperative laryngoscopy, up to 1 day
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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.
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From preoperative airway photography to completion of intraoperative laryngoscopy, up to 1 day
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Tavolara TE, Gurcan MN, Segal S, Niazi MKK. Identification of difficult to intubate patients from frontal face images using an ensemble of deep learning models. Comput Biol Med. 2021 Sep;136:104737. doi: 10.1016/j.compbiomed.2021.104737. Epub 2021 Aug 4.
- Wang Z, Jin Y, Zheng Y, Chen H, Feng J, Sun J. Evaluation of preoperative difficult airway prediction methods for adult patients without obvious airway abnormalities: a systematic review and meta-analysis. BMC Anesthesiol. 2024 Jul 17;24(1):242. doi: 10.1186/s12871-024-02627-1.
- Garcia-Garcia F, Lee DJ, Mendoza-Garces FJ, Garcia-Gutierrez S. Reliable prediction of difficult airway for tracheal intubation from patient preoperative photographs by machine learning methods. Comput Methods Programs Biomed. 2024 May;248:108118. doi: 10.1016/j.cmpb.2024.108118. Epub 2024 Mar 12.
Fechas de registro del estudio
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Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
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Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- E-28001928-604.01-318945497
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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