Classification and Prediction of Difficult Awake Tracheal Intubation With Flexible Bronchoscopes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Anesthesia, Airway Management, Intubation, Intratracheal, Bronchoscopy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Difficult awake flexible bronchoscopic intubation [Time frame: 1 hour]
Secondary outcome measures (12)
- First attempt success [Time frame: 1 hour]
- Number of bronchoscopy attempts [Time frame: 1 hour]
- Number of intubation attempts [Time frame: 1 hour]
- Successful ATI:FB [Time frame: 1 hour]
- Successful bronchoscopy [Time frame: 1 hour]
- Successful tube placement [Time frame: 1 hour]
- Coversion to another type of airway management [Time frame: 1 hour]
- Conversion from transnasal to transoral bronchoscopy or vice versa [Time frame: 1 hour]
- Percentage of glottic opening [Time frame: 1 hour]
- Glottic view [Time frame: 1 hour]
- Time to best glottic view [Time frame: 1 hour]
- Time to intubation [Time frame: 1 hour]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- University Medical Center Hamburg-Eppendorf — Hamburg
Publications
- Dohrmann T, Gutsche N, Kramer R, Zeidler EM, Roher K, Wunsch VA, Dankert A, Krause L, Zollner C, Sasu PB, Petzoldt M. Prospective development and validation of a universal classification for paediatric videolaryngoscopic tracheal intubation: the PeDiAC score. Anaesthesia. 2024 Nov;79(11):1201-1211. doi: 10.1111/anae.16394. Epub 2024 Aug 7. PMID 39108225
- Barclay-Steuart A, Grosshennig HL, Sasu P, Wunsch VA, Stadlhofer R, Berger J, Stark M, Sehner S, Zollner C, Petzoldt M. Transnasal Videoendoscopy for Preoperative Airway Risk Stratification: Development and Validation of a Multivariable Risk Prediction Model. Anesth Analg. 2023 Jun 1;136(6):1164-1173. doi: 10.1213/ANE.0000000000006418. Epub 2023 Apr 19. PMID 37074950
- Kohse EK, Siebert HK, Sasu PB, Loock K, Dohrmann T, Breitfeld P, Barclay-Steuart A, Stark M, Sehner S, Zollner C, Petzoldt M. A model to predict difficult airway alerts after videolaryngoscopy in adults with anticipated difficult airways - the VIDIAC score. Anaesthesia. 2022 Oct;77(10):1089-1096. doi: 10.1111/anae.15841. Epub 2022 Aug 25. PMID 36006056
Identifiers
NCT: NCT06953414 · 2025-101447-BO-ff