Clinical trial NCT06953414: Classification and Prediction of Difficult Awake Tracheal Intubation With Flexible Bronchoscopes
Official title: Classification and Prediction of Difficult Awake Tracheal Intubation With Flexible Bronchoscopes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anesthesia
Airway Management
Intubation, Intratracheal
Bronchoscopy
Endoscopes
Keywords: Airway management
Classification
Flexible endoscopy guided intubation
Fibroptic guided intubation
Respiratory system
Laryngeal diseases
Health records
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with anticipated difficult airways scheduled for surgery with general anaesthesia and tracheal intubation at a single study center

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.


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

Primary outcomes:
measure: Difficult awake flexible bronchoscopic intubation
timeFrame: 1 hour
Secondary outcomes:
measure: First attempt success
timeFrame: 1 hour
measure: Number of bronchoscopy attempts
timeFrame: 1 hour
measure: Number of intubation attempts
timeFrame: 1 hour
measure: Successful ATI:FB
timeFrame: 1 hour
measure: Successful bronchoscopy
timeFrame: 1 hour
measure: Successful tube placement
timeFrame: 1 hour
measure: Coversion to another type of airway management
timeFrame: 1 hour
measure: Conversion from transnasal to transoral bronchoscopy or vice versa
timeFrame: 1 hour
measure: Percentage of glottic opening
timeFrame: 1 hour
measure: Glottic view
timeFrame: 1 hour
measure: Time to best glottic view
timeFrame: 1 hour
measure: Time to intubation
timeFrame: 1 hour
measure: Lowest oxygen saturation
timeFrame: 1 hour
measure: Endtidal CO2
timeFrame: 1 hour
measure: Airway obstructions requiring external manipulation
timeFrame: 1 hour
measure: Hypoxia
timeFrame: 1 hour
measure: Cardiovascular event requiring intervention (hypotension/bradycardia)
timeFrame: 1 hour
measure: Cardiovascular event requiring intervention (hypertension, tachycardia)
timeFrame: 1 hour
measure: Additional manouvers and adjuncts used
timeFrame: 1 hour
measure: Patient discomfort during ATI:FB
timeFrame: 1 hour
measure: Airway-related complications
timeFrame: 1 hour
measure: Anaesthesia alert card issued
timeFrame: 1 hour
measure: Recommendation for future airway management
timeFrame: 1 hour
measure: Richmond agitation-sedation Scale
timeFrame: 1 hour
measure: Subjective rating of difficulty of sedation, topicalisation, bronchoscopy and tube placement
timeFrame: 1 hour
measure: Preparation time
timeFrame: 1 hour
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: University Medical Center Hamburg-Eppendorf: Universitatsklinikum Hamburg-Eppendorf
name: Martin Petzoldt, MD, FEAMS
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Hamburg-Eppendorf: Universitatsklinikum Hamburg-Eppendorf
name: Vera Köhl, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.