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Airway ManagementNCT06955884

Patient Experience of Transoral Versus Transnasal Awake Tracheal Intubation

An observational study of Airway Management and Fiberoptic Guided Intubation, 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 bronchoscopy and preserved spontaneous breathing (ATI:FB) is a recommended technique to manage difficult tracheal intubation in anaesthesia, intensive care and emergency medicine. Read more about this study

Who is it for?
Ages 18 years and older
How many people
198 participants
Where
1 siteGermany
Study dates
30 Jun 2025to 15 Dec 2025
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 scheduled for surgery requiring general anaesthesia at the study center university hospital medical center

Who may be able to join

  • patients scheduled for surgery requiring tracheal intubation
  • patients with an anticipated difficult airway requiring ATI:FB
  • consent by the patient
  • minimum 18 years of age

Who cannot join

  • patients scheduled for surgery requiring tracheal intubation
  • patients not scheduled for ATI:FB
  • pregnant or breastfeeding patients
  • consent withheld or not possible to obtain 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.

Germany1 site, 1 recruiting

  • University Medical Center Hamburg-Eppendorf

    Hamburg, Free and Hanseatic City of Hamburg, 20246

    Martin Petzoldt, M.D., +4915222815932, m.petzoldt@uke.de

    Vera Köhl, M.D., v.koehl@uke.de

    Recruiting

Other trials in Germany

About this study

Official title: Patient Experience of Transoral Versus Transnasal Awake Tracheal Intubation With Flexible Bronchoscopy - an Observational Study

Airway management problems are key drivers for anesthesia-related adverse events. Awake tracheal intubation using flexible bronchoscopy and preserved spontaneous breathing (ATI:FB) is a recommended technique to manage difficult tracheal intubation in anaesthesia, intensive care and emergency medicine. ATI:FB is regarded as the gold standard of tracheal intubation in many scenarios, however there is insufficient data on the patients experience while undergoing this form of airway management. ATI:FB can be facilitated using either a transnasal or transoral route. The study aims to compare patient-centred and operator-focused outcome parameters between these two different approaches with a focus on patient discomfort.

Keywords
airway management, flexible endoscopy guided intubation, patient discomfort

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06955884
Study groupRoleWhat they receive
Transnasal ATI:FBPatients undergoing airway management via the transnasal route
Transoral ATI:FBPatients undergoing airway management via the transoral route

What is being measured

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

  1. Patient reported discomfort experienced during ATI:FB

    recorded on a visual analog scale (1-100; lower values better)

    Measured: 24 hours after anaesthesia

Secondary outcomes (38)

  1. Patient reported recall of the ATI:FB

    yes/no and on a visual analog scale (1-100; lower values better)

    Measured: 24 hours after airway management

  2. Patient reported pain experienced during ATI:FB

    yes/no and on a visual analog scale (1-100; lower values better)

    Measured: 24 hours after airway management

  3. Patient reported fear experienced during ATI:FB

    yes/no and on a visual analog scale (1-100; lower values better)

    Measured: 24 hours after airway management

  4. Patient reported feeling of suffocation experienced during ATI:FB

    yes/no and on a visual analog scale (1-100; lower values better)

    Measured: 24 hours after airway management

  5. Patient reported dyspnea experienced during ATI:FB

    yes/no and on a visual analog scale (1-100; lower values better)

    Measured: 24 hours after airway management

  6. Patient reported distress experienced during ATI:FB

    yes/no and on a visual analog scale (1-100; lower values better)

    Measured: 24 hours after airway management

  7. Patient reported coughing experienced after ATI:FB

    yes/no and on a visual analog scale (1-100; lower values better)

    Measured: 24 hours after airway management

  8. Patient reported dry throat experienced after ATI:FB?

    yes/no and on a visual analog scale (1-100; lower values better)

    Measured: 24 hours after airway management

  9. Patient reported hoarseness experienced after ATI:FB

    yes/no and on a visual analog scale (1-100; lower values better)

    Measured: 24 hours after airway management

  10. Patient reported sleeping problems experienced after ATI:FB

    yes/no and on a visual analog scale (1-100; lower values better)

    Measured: 24 hours after airway management

  11. Patient reported occurrence of nightmares experienced after ATI:FB

    yes/no and on a visual analog scale (1-100; lower values better)

    Measured: 24 hours after airway management

  12. Patient reported preoperative expectation of discomfort to be experienced during ATI:FB

    yes/no and on a visual analog scale (1-100; lower values better)

    Measured: during preoperative assessment

  13. Patient reported preoperative fear of airway management

    yes/no and on a visual analog scale (1-100; lower values better)

    Measured: during preoperative assessment

  14. First attempt success

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

    Measured: 1 hour

  15. Number of bronchoscopy attempts

    Observed during airway management

    Measured: 1 hour

  16. Number of intubation attempts

    Observed during airway management

    Measured: 1 hour

  17. Successful ATI:FB

    Number of participants with successful ATI:FB

    Measured: 1 hour

  18. Successful bronchoscopy

    Number of participants with successful bronchoscopy

    Measured: 1 hour

  19. Successful tube placement

    Number of participants with successful tracheal tube placement

    Measured: 1 hour

  20. Conversion from transnasal to transoral bronchoscopy or vice versa

    Observed during airway management

    Measured: 1 hour

  21. Conversion to another type of airway management

    Observed during airway management

    Measured: 1 hour

  22. Percentage of glottic opening

    Grading of the best view obtained during laryngoscopy (%)

    Measured: 1 hour

  23. Glottic view

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

    Measured: 1 hour

  24. Time to best glottic view

    Recorded during airway management

    Measured: 1 hour

  25. Time to intubation

    Recorded during airway management

    Measured: 1 hour

  26. Lowest oxygen saturation

    Measured during airway management (%)

    Measured: 1 hour

  27. Endtidal CO2

    First value measured after intubation in mmHg

    Measured: 1 hour

  28. Airway obstructions requiring external manipulation

    yes/no

    Measured: 1 hour

  29. Hypoxia

    Lowest peripheral oxygen saturation measured by pulsoximetry in %

    Measured: 1 hour

  30. Cardiovascular event requiring intervention (hypotension/bradycardia)

    Observed during airway management

    Measured: 1 hour

  31. Cardiovascular event requiring intervention (hypertension, tachycardia)

    Observed during airway management

    Measured: 1 hour

  32. Additional manoeuvres and adjuncts

    Observed during airway management

    Measured: 1 hour

  33. Airway-related complications

    Recorded during airway management

    Measured: 1 hour

  34. Anaesthesia alert card issue

    Recorded after airway management

    Measured: 1 hour

  35. Recommendation for future airway management

    Recorded after airway management

    Measured: 1 hour

  36. Richmond Agitation-Sedation Scale

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

    Measured: 1 hour

  37. Subjective reporting of difficulty of sedation, topicalisation, bronchoscopy and tube placement

    On a visual analog scale (1-100)

    Measured: 1 hour

  38. 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 posted2 May 2025
  2. Study start30 Jun 2025
  3. Primary completion30 Nov 2025 (estimated)
  4. Study completion15 Dec 2025 (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
198 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06955884
Sponsor's protocol ID
2025-101503-BO-ff
Other IDs
2025
Status last verified
Jul 2025
First submitted
22 Apr 2025
Last updated
10 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Airway Management and Fiberoptic Guided Intubation, 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 4 inclusion and 4 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 10 Jul 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient reported discomfort experienced during ATI:FB (time frame: 24 hours after anaesthesia). 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 NCT06955884.

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 10 Jul 2025.

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