Classification and Prediction of Difficult Awake Tracheal Intubation With Flexible Bronchoscopes
Recruiting now
Conditions studied: Anesthesia, Airway Management, Intubation, Intratracheal, Bronchoscopy, Endoscopes
In brief
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.
Key facts
- Study ID
- NCT06953414
- Run by
- Universitätsklinikum Hamburg-Eppendorf
- People needed
- 313
- Starts
- 2025-04-30
- Expected to finish
- 2026-01-31
- Last updated by the study team
- 2025-05-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with an anticipated difficult airways scheduled for ATI:FB
- Consent by the patient
- Minimum 18 years of age
You may not qualify if…
- Patients not scheduled for ATI:FB
- Pregnant or breastfeeding patients
- Consent not given by the patient
Where it is running
- University Medical Center Hamburg-Eppendorf — Hamburg, Free and Hanseatic City of Hamburg, Germany (enrolling)
Full record on ClinicalTrials.gov
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