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AnesthesiaAirWakeNCT06953414

Classification and Prediction of Difficult Awake Tracheal Intubation With Flexible Bronchoscopes

An observational study of Anesthesia and Airway Management, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
313 participants
Where
1 siteGermany
Study dates
30 Apr 2025to 31 Jan 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with anticipated difficult airways scheduled for surgery with general anaesthesia and tracheal intubation at a single study center

Who may be able to join

  • Patients with an anticipated difficult airways scheduled for ATI:FB
  • Consent by the patient
  • Minimum 18 years of age

Who cannot join

  • Patients not scheduled for ATI:FB
  • Pregnant or breastfeeding patients
  • Consent not given by the patient

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Martin Petzoldt, MD, FEAMS contact

04915222815932

m.petzoldt@uke.de

Vera Köhl, MD contact

v.koehl@uke.de

Germany1 site, 1 recruiting

  • University Medical Center Hamburg-Eppendorf

    Hamburg, Free and Hanseatic City of Hamburg, 20246

    Martin Petzoldt, MD, 04915222815932, m.petzoldt@uke.de

    Recruiting

Other trials in Germany

About this study

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.

Keywords
Airway management, Classification, Flexible endoscopy guided intubation, Fibroptic guided intubation, Respiratory system, Laryngeal diseases, Health records
Medical subject headings
Laryngeal Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difficult awake flexible bronchoscopic intubation

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

    Measured: 1 hour

Secondary outcomes (26)

  1. First attempt success

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

    Measured: 1 hour

  2. Number of bronchoscopy attempts

    Observed during airway management

    Measured: 1 hour

  3. Number of intubation attempts

    Observed during airway management

    Measured: 1 hour

  4. Successful ATI:FB

    Number of participants with successful ATI:FB

    Measured: 1 hour

  5. Successful bronchoscopy

    Number of participants with successful bronchoscopy

    Measured: 1 hour

  6. Successful tube placement

    Number of participants with successful tracheal tube placement

    Measured: 1 hour

  7. Coversion to another type of airway management

    Observed during airway management

    Measured: 1 hour

  8. Conversion from transnasal to transoral bronchoscopy or vice versa

    Observed during airway management

    Measured: 1 hour

  9. Percentage of glottic opening

    Grading of the best view obtained during laryngoscopy (%)

    Measured: 1 hour

  10. Glottic view

    Grading of the best view obtained using landmarks (6-stages)

    Measured: 1 hour

  11. Time to best glottic view

    Recorded during airway management (seconds)

    Measured: 1 hour

  12. Time to intubation

    Recorded during airway management (seconds)

    Measured: 1 hour

  13. Lowest oxygen saturation

    Measured during airway management (%)

    Measured: 1 hour

  14. Endtidal CO2

    First value measured after intubation (mmHg)

    Measured: 1 hour

  15. Airway obstructions requiring external manipulation

    Observed during airway management

    Measured: 1 hour

  16. Hypoxia

    Observed during airway management

    Measured: 1 hour

  17. Cardiovascular event requiring intervention (hypotension/bradycardia)

    Relevant hypotension or bradycardia observed during airway management

    Measured: 1 hour

  18. Cardiovascular event requiring intervention (hypertension, tachycardia)

    Relevant hypertension or tachycardia observed during airway management

    Measured: 1 hour

  19. Additional manouvers and adjuncts used

    Observed during airway management

    Measured: 1 hour

  20. Patient discomfort during ATI:FB

    Observed during airway management

    Measured: 1 hour

  21. Airway-related complications

    Observed during airway management

    Measured: 1 hour

  22. Anaesthesia alert card issued

    Anaesthesia alert card issued by the airway operator

    Measured: 1 hour

  23. Recommendation for future airway management

    Recommendation documented by the airway operator after airway management

    Measured: 1 hour

  24. Richmond agitation-sedation Scale

    Observed during airway management (scale form -4 to 5 points; lower values indicate deeper sedation)

    Measured: 1 hour

  25. Subjective rating of difficulty of sedation, topicalisation, bronchoscopy and tube placement

    Rating of the airway operator (visual analog scales [0-100]; lower values indicate better conditions)

    Measured: 1 hour

  26. Preparation time

    Recorded during airway management

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2025
  2. Study start30 Apr 2025
  3. Primary completion31 Jan 2026 (estimated)
  4. Study completion31 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
313 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06953414
Sponsor's protocol ID
2025-101447-BO-ff
Other IDs
2025
Acronym
AirWake
Status last verified
Apr 2025
First submitted
22 Apr 2025
Last updated
6 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Dohrmann T, Gutsche N, Kramer R, Zeidler EM, Roher K, Wunsch VA, Dankert A, Krause L, Zollner C, Sasu PB, Petzoldt M. Prospective development and validation of a universal classification for paediatric videolaryngoscopic tracheal intubation: the PeDiAC score. Anaesthesia. 2024 Nov;79(11):1201-1211. doi: 10.1111/anae.16394. Epub 2024 Aug 7.

    PubMed 39108225

  • Barclay-Steuart A, Grosshennig HL, Sasu P, Wunsch VA, Stadlhofer R, Berger J, Stark M, Sehner S, Zollner C, Petzoldt M. Transnasal Videoendoscopy for Preoperative Airway Risk Stratification: Development and Validation of a Multivariable Risk Prediction Model. Anesth Analg. 2023 Jun 1;136(6):1164-1173. doi: 10.1213/ANE.0000000000006418. Epub 2023 Apr 19.

    PubMed 37074950

  • Kohse EK, Siebert HK, Sasu PB, Loock K, Dohrmann T, Breitfeld P, Barclay-Steuart A, Stark M, Sehner S, Zollner C, Petzoldt M. A model to predict difficult airway alerts after videolaryngoscopy in adults with anticipated difficult airways - the VIDIAC score. Anaesthesia. 2022 Oct;77(10):1089-1096. doi: 10.1111/anae.15841. Epub 2022 Aug 25.

    PubMed 36006056

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia and Airway Management, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Martin Petzoldt, MD, FEAMS (04915222815932, m.petzoldt@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difficult awake flexible bronchoscopic intubation (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06953414, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.

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