Clinical trial NCT06955884: Patient Experience of Transoral Versus Transnasal Awake Tracheal Intubation
Official title: Patient Experience of Transoral Versus Transnasal Awake Tracheal Intubation With Flexible Bronchoscopy - an Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Airway Management
Fiberoptic Guided Intubation
Patient Experience
Keywords: airway management
flexible endoscopy guided intubation
patient discomfort
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for surgery requiring general anaesthesia at the study center university hospital medical center

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.


Eligibility 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

Primary outcomes:
measure: Patient reported discomfort experienced during ATI:FB
timeFrame: 24 hours after anaesthesia
Secondary outcomes:
measure: Patient reported recall of the ATI:FB
timeFrame: 24 hours after airway management
measure: Patient reported pain experienced during ATI:FB
timeFrame: 24 hours after airway management
measure: Patient reported fear experienced during ATI:FB
timeFrame: 24 hours after airway management
measure: Patient reported feeling of suffocation experienced during ATI:FB
timeFrame: 24 hours after airway management
measure: Patient reported dyspnea experienced during ATI:FB
timeFrame: 24 hours after airway management
measure: Patient reported distress experienced during ATI:FB
timeFrame: 24 hours after airway management
measure: Patient reported coughing experienced after ATI:FB
timeFrame: 24 hours after airway management
measure: Patient reported dry throat experienced after ATI:FB?
timeFrame: 24 hours after airway management
measure: Patient reported hoarseness experienced after ATI:FB
timeFrame: 24 hours after airway management
measure: Patient reported sleeping problems experienced after ATI:FB
timeFrame: 24 hours after airway management
measure: Patient reported occurrence of nightmares experienced after ATI:FB
timeFrame: 24 hours after airway management
measure: Patient reported preoperative expectation of discomfort to be experienced during ATI:FB
timeFrame: during preoperative assessment
measure: Patient reported preoperative fear of airway management
timeFrame: during preoperative assessment
measure: First attempt success
timeFrame: 1 hour
measure: Number of bronchoscopy attempts
timeFrame: 1 hour
measure: Number of intubation attempts
timeFrame: 1 hour
measure: Successful ATI:FB
timeFrame: 1 hour
measure: Successful bronchoscopy
timeFrame: 1 hour
measure: Successful tube placement
timeFrame: 1 hour
measure: Conversion from transnasal to transoral bronchoscopy or vice versa
timeFrame: 1 hour
measure: Conversion to another type of airway management
timeFrame: 1 hour
measure: Percentage of glottic opening
timeFrame: 1 hour
measure: Glottic view
timeFrame: 1 hour
measure: Time to best glottic view
timeFrame: 1 hour
measure: Time to intubation
timeFrame: 1 hour
measure: Lowest oxygen saturation
timeFrame: 1 hour
measure: Endtidal CO2
timeFrame: 1 hour
measure: Airway obstructions requiring external manipulation
timeFrame: 1 hour
measure: Hypoxia
timeFrame: 1 hour
measure: Cardiovascular event requiring intervention (hypotension/bradycardia)
timeFrame: 1 hour
measure: Cardiovascular event requiring intervention (hypertension, tachycardia)
timeFrame: 1 hour
measure: Additional manoeuvres and adjuncts
timeFrame: 1 hour
measure: Airway-related complications
timeFrame: 1 hour
measure: Anaesthesia alert card issue
timeFrame: 1 hour
measure: Recommendation for future airway management
timeFrame: 1 hour
measure: Richmond Agitation-Sedation Scale
timeFrame: 1 hour
measure: Subjective reporting of difficulty of sedation, topicalisation, bronchoscopy and tube placement
timeFrame: 1 hour
measure: Preparation time
timeFrame: 1 hour
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
References: