NCT06953414 Classification and Prediction of Difficult Awake Tracheal Intubation With Flexible Bronchoscopes
| NCT ID | NCT06953414 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf |
| Condition | Anesthesia |
| Study Type | OBSERVATIONAL |
| Enrollment | 313 participants |
| Start Date | 2025-04-30 |
| Primary Completion | 2026-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 313 participants in total. It began in 2025-04-30 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Martin Petzoldt, MD, FEAMS
PRINCIPAL INVESTIGATOR
University Medical Center Hamburg-Eppendorf: Universitatsklinikum Hamburg-Eppendorf
Frequently Asked Questions
Who can join the NCT06953414 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anesthesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06953414 currently recruiting?
Yes, NCT06953414 is actively recruiting participants. Contact the research team at m.petzoldt@uke.de for enrollment information.
Where is the NCT06953414 trial being conducted?
This trial is being conducted at Hamburg, Germany.
Who is sponsoring the NCT06953414 clinical trial?
NCT06953414 is sponsored by Universitätsklinikum Hamburg-Eppendorf. The principal investigator is Martin Petzoldt, MD, FEAMS at University Medical Center Hamburg-Eppendorf: Universitatsklinikum Hamburg-Eppendorf. The trial plans to enroll 313 participants.