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

7. juli 2026 opdateret af: 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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

319

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diagnostic Performance of Multimodal AI Models for Predicting Difficult Intubation
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diagnostic Performance of Multimodal AI Models for Predicting Difficult Laryngoscopy
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. juni 2026

Primær færdiggørelse (Anslået)

1. september 2026

Studieafslutning (Anslået)

1. september 2026

Datoer for studieregistrering

Først indsendt

7. juli 2026

Først indsendt, der opfyldte QC-kriterier

7. juli 2026

Først opslået (Faktiske)

14. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Svær intubation

3
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