Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06955884

Patient Experience of Transoral Versus Transnasal Awake Tracheal Intubation

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

Location status: Recruiting

Location contact

Martin Petzoldt, M.D.

CONTACT

[email protected]

+4915222815932

Martin Petzoldt, M.D.

PRINCIPAL_INVESTIGATOR

Vera Köhl, M.D.

CONTACT

[email protected]

Vera Köhl, M.D.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Patient reported discomfort experienced during ATI:FB

    Time frame: 24 hours after anaesthesia

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

Secondary outcomes

  1. Patient reported recall of the ATI:FB

    Time frame: 24 hours after airway management

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

  2. Patient reported pain experienced during ATI:FB

    Time frame: 24 hours after airway management

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

  3. Patient reported fear experienced during ATI:FB

    Time frame: 24 hours after airway management

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

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

    Time frame: 24 hours after airway management

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

  5. Patient reported dyspnea experienced during ATI:FB

    Time frame: 24 hours after airway management

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

  6. Patient reported distress experienced during ATI:FB

    Time frame: 24 hours after airway management

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

  7. Patient reported coughing experienced after ATI:FB

    Time frame: 24 hours after airway management

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

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

    Time frame: 24 hours after airway management

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

  9. Patient reported hoarseness experienced after ATI:FB

    Time frame: 24 hours after airway management

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

  10. Patient reported sleeping problems experienced after ATI:FB

    Time frame: 24 hours after airway management

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

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

    Time frame: 24 hours after airway management

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

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

    Time frame: during preoperative assessment

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

  13. Patient reported preoperative fear of airway management

    Time frame: during preoperative assessment

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

  14. First attempt success

    Time frame: 1 hour

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

  15. Number of bronchoscopy attempts

    Time frame: 1 hour

    Observed during airway management

  16. Number of intubation attempts

    Time frame: 1 hour

    Observed during airway management

  17. Successful ATI:FB

    Time frame: 1 hour

    Number of participants with successful ATI:FB

  18. Successful bronchoscopy

    Time frame: 1 hour

    Number of participants with successful bronchoscopy

  19. Successful tube placement

    Time frame: 1 hour

    Number of participants with successful tracheal tube placement

  20. Conversion from transnasal to transoral bronchoscopy or vice versa

    Time frame: 1 hour

    Observed during airway management

  21. Conversion to another type of airway management

    Time frame: 1 hour

    Observed during airway management

  22. Percentage of glottic opening

    Time frame: 1 hour

    Grading of the best view obtained during laryngoscopy (%)

  23. Glottic view

    Time frame: 1 hour

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

  24. Time to best glottic view

    Time frame: 1 hour

    Recorded during airway management

  25. Time to intubation

    Time frame: 1 hour

    Recorded during airway management

  26. Lowest oxygen saturation

    Time frame: 1 hour

    Measured during airway management (%)

  27. Endtidal CO2

    Time frame: 1 hour

    First value measured after intubation in mmHg

  28. Airway obstructions requiring external manipulation

    Time frame: 1 hour

    yes/no

  29. Hypoxia

    Time frame: 1 hour

    Lowest peripheral oxygen saturation measured by pulsoximetry in %

  30. Cardiovascular event requiring intervention (hypotension/bradycardia)

    Time frame: 1 hour

    Observed during airway management

  31. Cardiovascular event requiring intervention (hypertension, tachycardia)

    Time frame: 1 hour

    Observed during airway management

  32. Additional manoeuvres and adjuncts

    Time frame: 1 hour

    Observed during airway management

  33. Airway-related complications

    Time frame: 1 hour

    Recorded during airway management

  34. Anaesthesia alert card issue

    Time frame: 1 hour

    Recorded after airway management

  35. Recommendation for future airway management

    Time frame: 1 hour

    Recorded after airway management

  36. Richmond Agitation-Sedation Scale

    Time frame: 1 hour

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

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

    Time frame: 1 hour

    On a visual analog scale (1-100)

  38. Preparation time

    Time frame: 1 hour

    Recorded during airway management

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 2, 2025
Registry last updated
Jul 10, 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.

Published trials that share one or more normalized conditions with this study.