Airway Management, Anesthesia, Bronchoscopy, Endoscopes, Intubation, Intratracheal
Conditions
Keywords
Airway management, Classification, Flexible endoscopy guided intubation, Fibroptic guided intubation, Respiratory system, Laryngeal diseases, Health records
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.
Interventions
None listed
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difficult awake flexible bronchoscopic intubation | 1 hour | Difficult airway alert issued by the airway operator following ATI:FB |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Successful tube placement | 1 hour | Number of participants with successful tracheal tube placement |
| Successful ATI:FB | 1 hour | Number of participants with successful ATI:FB |
| Successful bronchoscopy | 1 hour | Number of participants with successful bronchoscopy |
| 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 |
| Anaesthesia alert card issued | 1 hour | Anaesthesia alert card issued by the airway operator |
| 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 |
| Number of intubation attempts | 1 hour | Observed during airway management |
Countries
Germany
Contacts
Primary ContactMartin Petzoldt, MD, FEAMS
Backup ContactVera Köhl, MD
Outcome results
None listed