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Patient Experience of Transoral Versus Transnasal Awake Tracheal Intubation

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06955884
Enrollment
198
Registered
2025-05-02
Start date
2025-06-30
Completion date
2025-12-15
Last updated
2025-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Management, Fiberoptic Guided Intubation, Patient Experience

Keywords

airway management, flexible endoscopy guided intubation, patient discomfort

Brief 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. 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.

Interventions

None listed

Sponsors

Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patient reported discomfort experienced during ATI:FB24 hours after anaesthesiarecorded on a visual analog scale (1-100; lower values better)

Secondary

MeasureTime frameDescription
Conversion to another type of airway management1 hourObserved during airway management
Percentage of glottic opening1 hourGrading of the best view obtained during laryngoscopy (%)
Glottic view1 hourGrading of the best view obtained using landmarks (6 stages)
Time to best glottic view1 hourRecorded during airway management
Patient reported recall of the ATI:FB24 hours after airway managementyes/no and on a visual analog scale (1-100; lower values better)
Patient reported pain experienced during ATI:FB24 hours after airway managementyes/no and on a visual analog scale (1-100; lower values better)
Patient reported fear experienced during ATI:FB24 hours after airway managementyes/no and on a visual analog scale (1-100; lower values better)
Patient reported feeling of suffocation experienced during ATI:FB24 hours after airway managementyes/no and on a visual analog scale (1-100; lower values better)
Patient reported dyspnea experienced during ATI:FB24 hours after airway managementyes/no and on a visual analog scale (1-100; lower values better)
Patient reported distress experienced during ATI:FB24 hours after airway managementyes/no and on a visual analog scale (1-100; lower values better)
Patient reported coughing experienced after ATI:FB24 hours after airway managementyes/no and on a visual analog scale (1-100; lower values better)
Patient reported dry throat experienced after ATI:FB?24 hours after airway managementyes/no and on a visual analog scale (1-100; lower values better)
Patient reported hoarseness experienced after ATI:FB24 hours after airway managementyes/no and on a visual analog scale (1-100; lower values better)
Patient reported sleeping problems experienced after ATI:FB24 hours after airway managementyes/no and on a visual analog scale (1-100; lower values better)
Patient reported occurrence of nightmares experienced after ATI:FB24 hours after airway managementyes/no and on a visual analog scale (1-100; lower values better)
Patient reported preoperative expectation of discomfort to be experienced during ATI:FBduring preoperative assessmentyes/no and on a visual analog scale (1-100; lower values better)
Patient reported preoperative fear of airway managementduring preoperative assessmentyes/no and on a visual analog scale (1-100; lower values better)
First attempt success1 hournumber of participants with successful ATI:FB with only one attempt
Conversion from transnasal to transoral bronchoscopy or vice versa1 hourObserved during airway management
Number of intubation attempts1 hourObserved during airway management
Successful ATI:FB1 hourNumber of participants with successful ATI:FB
Successful bronchoscopy1 hourNumber of participants with successful bronchoscopy
Successful tube placement1 hourNumber of participants with successful tracheal tube placement
Time to intubation1 hourRecorded during airway management
Lowest oxygen saturation1 hourMeasured during airway management (%)
Endtidal CO21 hourFirst value measured after intubation in mmHg
Airway obstructions requiring external manipulation1 houryes/no
Hypoxia1 hourLowest peripheral oxygen saturation measured by pulsoximetry in %
Cardiovascular event requiring intervention (hypotension/bradycardia)1 hourObserved during airway management
Cardiovascular event requiring intervention (hypertension, tachycardia)1 hourObserved during airway management
Additional manoeuvres and adjuncts1 hourObserved during airway management
Airway-related complications1 hourRecorded during airway management
Anaesthesia alert card issue1 hourRecorded after airway management
Recommendation for future airway management1 hourRecorded after airway management
Richmond Agitation-Sedation Scale1 hourObserved during airway management (-5 to 4; lower values indicate deeper sedation)
Subjective reporting of difficulty of sedation, topicalisation, bronchoscopy and tube placement1 hourOn a visual analog scale (1-100)
Preparation time1 hourRecorded during airway management
Number of bronchoscopy attempts1 hourObserved during airway management

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026