Classification and Prediction of Difficult Awake Tracheal Intubation With Flexible Bronchoscopes

Recruiting

• Conditions: Anesthesia; Airway Management; Intubation, Intratracheal; Bronchoscopy; Endoscopes

• Registration Number: NCT06953414
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-22
• Study First Submitted QC: 2025-04-29
• Study Start: 2025-04-30
• Study First Posted: 2025-05-01
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-06
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 313

Inclusion Criteria

• Patients with an anticipated difficult airways scheduled for ATI:FB
• Consent by the patient
• Minimum 18 years of age

Exclusion Criteria

• Patients not scheduled for ATI:FB
• Pregnant or breastfeeding patients
• Consent not given by the patient

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difficult awake flexible bronchoscopic intubation	1 hour	Difficult airway alert issued by the airway operator following ATI:FB

Secondary Outcome Measures

Name	Time	Method
First attempt success	1 hour	Number of participants with successful ATI:FB with only one attempt
Number of bronchoscopy attempts	1 hour	Observed during airway management
Number of intubation attempts	1 hour	Observed during airway management
Successful ATI:FB	1 hour	Number of participants with successful ATI:FB
Successful bronchoscopy	1 hour	Number of participants with successful bronchoscopy
Successful tube placement	1 hour	Number of participants with successful tracheal tube placement
Coversion to another type of airway management	1 hour	Observed during airway management
Conversion from transnasal to transoral bronchoscopy or vice versa	1 hour	Observed during airway management
Percentage of glottic opening	1 hour	Grading of the best view obtained during laryngoscopy (%)
Glottic view	1 hour	Grading of the best view obtained using landmarks (6-stages)
Time to best glottic view	1 hour	Recorded during airway management (seconds)
Time to intubation	1 hour	Recorded during airway management (seconds)
Lowest oxygen saturation	1 hour	Measured during airway management (%)
Endtidal CO2	1 hour	First value measured after intubation (mmHg)
Airway obstructions requiring external manipulation	1 hour	Observed during airway management
Hypoxia	1 hour	Observed during airway management
Cardiovascular event requiring intervention (hypotension/bradycardia)	1 hour	Relevant hypotension or bradycardia observed during airway management
Cardiovascular event requiring intervention (hypertension, tachycardia)	1 hour	Relevant hypertension or tachycardia observed during airway management
Additional manouvers and adjuncts used	1 hour	Observed during airway management
Patient discomfort during ATI:FB	1 hour	Observed during airway management
Airway-related complications	1 hour	Observed during airway management
Recommendation for future airway management	1 hour	Recommendation documented by the airway operator after airway management
Richmond agitation-sedation Scale	1 hour	Observed during airway management (scale form -4 to 5 points; lower values indicate deeper sedation)
Subjective rating of difficulty of sedation, topicalisation, bronchoscopy and tube placement	1 hour	Rating of the airway operator (visual analog scales \[0-100\]; lower values indicate better conditions)
Preparation time	1 hour	Recorded during airway management
Anaesthesia alert card issued	1 hour	Anaesthesia alert card issued by the airway operator

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany