An observational study in Anesthesia, Airway Management and Intubation, Intratracheal, sponsored by Universitätsklinikum Hamburg-Eppendorf. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-06.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Observational
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.
140 studies on the registry are indexed under Laryngeal Diseases; 24 are open to participants now.
This study's planned enrollment of 313 is above the median of 100 across 21 observational studies indexed under Laryngeal Diseases.
Browse Laryngeal Diseases studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 415 studies on the registry; 85 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with anticipated difficult airways scheduled for surgery with general anaesthesia and tracheal intubation at a single study center
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Difficult awake flexible bronchoscopic intubation
Difficult airway alert issued by the airway operator following ATI:FB
Time frame: 1 hour
First attempt success
Number of participants with successful ATI:FB with only one attempt
Time frame: 1 hour
Number of bronchoscopy attempts
Observed during airway management
Time frame: 1 hour
Number of intubation attempts
Observed during airway management
Time frame: 1 hour
Successful ATI:FB
Number of participants with successful ATI:FB
Time frame: 1 hour
Successful bronchoscopy
Number of participants with successful bronchoscopy
Time frame: 1 hour
Successful tube placement
Number of participants with successful tracheal tube placement
Time frame: 1 hour
Coversion to another type of airway management
Observed during airway management
Time frame: 1 hour
Conversion from transnasal to transoral bronchoscopy or vice versa
Observed during airway management
Time frame: 1 hour
Percentage of glottic opening
Grading of the best view obtained during laryngoscopy (%)
Time frame: 1 hour
Glottic view
Grading of the best view obtained using landmarks (6-stages)
Time frame: 1 hour
Time to best glottic view
Recorded during airway management (seconds)
Time frame: 1 hour
Time to intubation
Recorded during airway management (seconds)
Time frame: 1 hour
Lowest oxygen saturation
Measured during airway management (%)
Time frame: 1 hour
Endtidal CO2
First value measured after intubation (mmHg)
Time frame: 1 hour
Airway obstructions requiring external manipulation
Observed during airway management
Time frame: 1 hour
Hypoxia
Observed during airway management
Time frame: 1 hour
Cardiovascular event requiring intervention (hypotension/bradycardia)
Relevant hypotension or bradycardia observed during airway management
Time frame: 1 hour
Cardiovascular event requiring intervention (hypertension, tachycardia)
Relevant hypertension or tachycardia observed during airway management
Time frame: 1 hour
Additional manouvers and adjuncts used
Observed during airway management
Time frame: 1 hour
Patient discomfort during ATI:FB
Observed during airway management
Time frame: 1 hour
Airway-related complications
Observed during airway management
Time frame: 1 hour
Anaesthesia alert card issued
Anaesthesia alert card issued by the airway operator
Time frame: 1 hour
Recommendation for future airway management
Recommendation documented by the airway operator after airway management
Time frame: 1 hour
Richmond agitation-sedation Scale
Observed during airway management (scale form -4 to 5 points; lower values indicate deeper sedation)
Time frame: 1 hour
Subjective rating of difficulty of sedation, topicalisation, bronchoscopy and tube placement
Rating of the airway operator (visual analog scales \[0-100\]; lower values indicate better conditions)
Time frame: 1 hour
Preparation time
Recorded during airway management
Time frame: 1 hour
Started Apr 2025 (actual). Primary completion is estimated for Jan 2026, 9 months after the start.
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