Classification and Prediction of Difficult Awake Tracheal Intubation With Flexible Bronchoscopes

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitätsklinikum Hamburg-Eppendorf

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Difficult awake flexible bronchoscopic intubation

Difficult airway alert issued by the airway operator following ATI:FB

Time frame
1 hour

Secondary outcomes

1

First attempt success

Number of participants with successful ATI:FB with only one attempt

Time frame
1 hour
2

Number of bronchoscopy attempts

Observed during airway management

Time frame
1 hour
3

Number of intubation attempts

Observed during airway management

Time frame
1 hour
4

Successful ATI:FB

Number of participants with successful ATI:FB

Time frame
1 hour

Other outcomes

Sponsors and contacts

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