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NCT Number: NCT07700485

Preoperative Airway Images for Difficult Airway Prediction

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Istanbul, Kadıköy, 34734, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diagnostic Performance of Multimodal AI Models for Predicting Difficult Intubation

    Time frame: 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.

Secondary outcomes

  1. Diagnostic Performance of Multimodal AI Models for Predicting Difficult Laryngoscopy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Memorial Atasehir Hospital

Other

Registry information

Official study title

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

Acronym: AI-AIRWAY

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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