University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany
Location status: Recruiting
Recruiting
NCT Number: NCT06953414
Classification and Prediction of Difficult Awake Tracheal Intubation With Flexible Bronchoscopes
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Difficult awake flexible bronchoscopic intubation
Time frame: 1 hour
Difficult airway alert issued by the airway operator following ATI:FB
Secondary outcomes
-
First attempt success
Time frame: 1 hour
Number of participants with successful ATI:FB with only one attempt
-
Number of bronchoscopy attempts
Time frame: 1 hour
Observed during airway management
-
Number of intubation attempts
Time frame: 1 hour
Observed during airway management
-
Successful ATI:FB
Time frame: 1 hour
Number of participants with successful ATI:FB
-
Successful bronchoscopy
Time frame: 1 hour
Number of participants with successful bronchoscopy
-
Successful tube placement
Time frame: 1 hour
Number of participants with successful tracheal tube placement
-
Coversion to another type of airway management
Time frame: 1 hour
Observed during airway management
-
Conversion from transnasal to transoral bronchoscopy or vice versa
Time frame: 1 hour
Observed during airway management
-
Percentage of glottic opening
Time frame: 1 hour
Grading of the best view obtained during laryngoscopy (%)
-
Glottic view
Time frame: 1 hour
Grading of the best view obtained using landmarks (6-stages)
-
Time to best glottic view
Time frame: 1 hour
Recorded during airway management (seconds)
-
Time to intubation
Time frame: 1 hour
Recorded during airway management (seconds)
-
Lowest oxygen saturation
Time frame: 1 hour
Measured during airway management (%)
-
Endtidal CO2
Time frame: 1 hour
First value measured after intubation (mmHg)
-
Airway obstructions requiring external manipulation
Time frame: 1 hour
Observed during airway management
-
Hypoxia
Time frame: 1 hour
Observed during airway management
-
Cardiovascular event requiring intervention (hypotension/bradycardia)
Time frame: 1 hour
Relevant hypotension or bradycardia observed during airway management
-
Cardiovascular event requiring intervention (hypertension, tachycardia)
Time frame: 1 hour
Relevant hypertension or tachycardia observed during airway management
-
Additional manouvers and adjuncts used
Time frame: 1 hour
Observed during airway management
-
Patient discomfort during ATI:FB
Time frame: 1 hour
Observed during airway management
-
Airway-related complications
Time frame: 1 hour
Observed during airway management
-
Anaesthesia alert card issued
Time frame: 1 hour
Anaesthesia alert card issued by the airway operator
-
Recommendation for future airway management
Time frame: 1 hour
Recommendation documented by the airway operator after airway management
-
Richmond agitation-sedation Scale
Time frame: 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
Time frame: 1 hour
Rating of the airway operator (visual analog scales [0-100]; lower values indicate better conditions)
-
Preparation time
Time frame: 1 hour
Recorded during airway management
Study contacts
Contact information is provided by the study sponsor or research team.
Martin Petzoldt, MD, FEAMS
CONTACT
Vera Köhl, MD
CONTACT
Sponsors and collaborators
Lead sponsor
Universitätsklinikum Hamburg-Eppendorf
Other
Registry information
Acronym: AirWake
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- May 1, 2025
- Registry last updated
- May 6, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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