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Classification and Prediction of Difficult Awake Tracheal Intubation With Flexible Bronchoscopes

NCT06953414 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 313

Last updated 2025-05-06

No results posted yet for this study

Summary

Airway management problems are key drivers for anesthesia-related adverse events. Awake tracheal intubation using flexible bronchoscopes with preserved spontaneous breathing (ATI:FB) is a recommended technique to manage difficult tracheal intubation in anesthesia, intensive care and emergency medicine. However, a prospective developed classification for this type of airway management is lacking. Due to the absence of a specifically tailored, validated classification for awake intubation with flexible bronchoscopes, many airway operators and institutions use classification tools that were originally developed for direct laryngoscopy, such as the percentage of glottic opening (POGO) score or Cormack-Lehane classification, although their diagnostic performance for the classification of ATI:FB is unknown. This prospective model development and validation study aims to develop two multivariable prediction models: a diagnostic prediction model to classify difficult ATI:FB after ATI:FB has been performed and a second prognostic prediction model to predict the risk for difficult ATI:FB before ATI:FB is performed. An additional aim is to develop a machine learning algorithm to evaluate ATI:FB.

Conditions

  • Anesthesia
  • Airway Management
  • Intubation, Intratracheal
  • Bronchoscopy
  • Endoscopes

Sponsors & Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Martin Petzoldt, MD, FEAMS · University Medical Center Hamburg-Eppendorf: Universitatsklinikum Hamburg-Eppendorf

  • Vera Köhl, MD · University Medical Center Hamburg-Eppendorf: Universitatsklinikum Hamburg-Eppendorf

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2026-01-31
Completion
2026-01-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06953414 on ClinicalTrials.gov