About this trial
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
This trial does not accept healthy volunteersQualifiers
Patients with an anticipated difficult airways scheduled for ATI:FB
Consent by the patient
Minimum 18 years of age
Disqualifiers
Patients not scheduled for ATI:FB
Pregnant or breastfeeding patients
Consent not given by the patient
Trial population
Patients with anticipated difficult airways scheduled for surgery with general anaesthesia and tracheal intubation at a single study center
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Difficult awake flexible bronchoscopic intubation
Difficult airway alert issued by the airway operator following ATI:FB
Secondary outcomes
First attempt success
Number of participants with successful ATI:FB with only one attempt
Number of bronchoscopy attempts
Observed during airway management
Number of intubation attempts
Observed during airway management
Successful ATI:FB
Number of participants with successful ATI:FB
Sponsors and contacts
Click on the lead sponsor to view all of their trials.