Comparing awake tracheal intubation through the mouth versus the nose.
Patient Experience of Transoral Versus Transnasal Awake Tracheal Intubation With Flexible Bronchoscopy - an Observational Study
This study will test whether awake tracheal intubation through the mouth or the nose causes less discomfort for adults who need flexible bronchoscopy-guided intubation for a difficult airway.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 198 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Locations | 1 site (Hamburg, Free and Hanseatic City of Hamburg) |
| Trial ID | NCT06955884 on ClinicalTrials.gov |
What this trial studies
This is an observational comparison of two routes for awake tracheal intubation using flexible bronchoscopy with preserved spontaneous breathing (ATI:FB). Adults with an anticipated difficult airway who are scheduled for surgery and consent to ATI:FB will undergo either a transnasal or transoral approach as used by their clinical team. The study will collect patient-reported discomfort and tolerance measures plus operator-focused metrics such as procedure time, ease of tube passage, and immediate complications. Data will be analyzed to compare patient-centred and operator-centred outcomes between the two routes.
Who should consider this trial
Good fit: Adults (18+) scheduled for surgery with an anticipated difficult airway who are planned to receive awake flexible bronchoscopy-guided tracheal intubation and can provide informed consent are ideal candidates.
Not a fit: People who do not require awake bronchoscopy-guided intubation, pregnant or breastfeeding patients, minors, or those unable to give consent are unlikely to benefit from joining this observational comparison.
Why it matters
Potential benefit: If successful, the results could help clinicians choose the intubation route that reduces patient discomfort and improves tolerance and procedural efficiency during awake bronchoscopy-guided intubation.
How similar studies have performed: Awake bronchoscopy-guided intubation is an established technique, but direct head-to-head data comparing patient discomfort between transnasal and transoral routes are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hamburg, Free and Hanseatic City of Hamburg
- University Medical Center Hamburg-Eppendorf — Hamburg, Free and Hanseatic City of Hamburg, Germany (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.