Patient Experience of Transoral Versus Transnasal Awake Tracheal Intubation
- Conditions
- Airway ManagementFiberoptic Guided IntubationPatient Experience
- Registration Number
- NCT06955884
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 198
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient reported discomfort experienced during ATI:FB 24 hours after anaesthesia recorded on a visual analog scale (1-100; lower values better)
- Secondary Outcome Measures
Name Time Method Patient reported recall of the ATI:FB 24 hours after airway management yes/no and on a visual analog scale (1-100; lower values better)
Patient reported pain experienced during ATI:FB 24 hours after airway management yes/no and on a visual analog scale (1-100; lower values better)
Patient reported fear experienced during ATI:FB 24 hours after airway management yes/no and on a visual analog scale (1-100; lower values better)
Patient reported feeling of suffocation experienced during ATI:FB 24 hours after airway management yes/no and on a visual analog scale (1-100; lower values better)
Patient reported dyspnea experienced during ATI:FB 24 hours after airway management yes/no and on a visual analog scale (1-100; lower values better)
Patient reported distress experienced during ATI:FB 24 hours after airway management yes/no and on a visual analog scale (1-100; lower values better)
Patient reported coughing experienced after ATI:FB 24 hours after airway management yes/no and on a visual analog scale (1-100; lower values better)
Patient reported dry throat experienced after ATI:FB? 24 hours after airway management yes/no and on a visual analog scale (1-100; lower values better)
Patient reported hoarseness experienced after ATI:FB 24 hours after airway management yes/no and on a visual analog scale (1-100; lower values better)
Patient reported sleeping problems experienced after ATI:FB 24 hours after airway management yes/no and on a visual analog scale (1-100; lower values better)
Patient reported occurrence of nightmares experienced after ATI:FB 24 hours after airway management yes/no and on a visual analog scale (1-100; lower values better)
Conversion to another type of airway management 1 hour Observed during airway management
Percentage of glottic opening 1 hour Grading of the best view obtained during laryngoscopy (%)
Glottic view 1 hour Grading of the best view obtained using landmarks (6 stages)
Time to best glottic view 1 hour Recorded during airway management
Time to intubation 1 hour Recorded during airway management
Lowest oxygen saturation 1 hour Measured during airway management (%)
Endtidal CO2 1 hour First value measured after intubation in mmHg
Airway obstructions requiring external manipulation 1 hour yes/no
Hypoxia 1 hour Lowest peripheral oxygen saturation measured by pulsoximetry in %
Cardiovascular event requiring intervention (hypotension/bradycardia) 1 hour Observed during airway management
Cardiovascular event requiring intervention (hypertension, tachycardia) 1 hour Observed during airway management
Additional manoeuvres and adjuncts 1 hour Observed during airway management
Airway-related complications 1 hour Recorded during airway management
Anaesthesia alert card issue 1 hour Recorded after airway management
Recommendation for future airway management 1 hour Recorded after airway management
Richmond Agitation-Sedation Scale 1 hour Observed during airway management (-5 to 4; lower values indicate deeper sedation)
Subjective reporting of difficulty of sedation, topicalisation, bronchoscopy and tube placement 1 hour On a visual analog scale (1-100)
Preparation time 1 hour Recorded during airway management
Patient reported preoperative expectation of discomfort to be experienced during ATI:FB during preoperative assessment yes/no and on a visual analog scale (1-100; lower values better)
Patient reported preoperative fear of airway management during preoperative assessment yes/no and on a visual analog scale (1-100; lower values better)
First attempt success 1 hour number of participants with successful ATI:FB with only one attempt
Number of bronchoscopy attempts 1 hour Observed during airway management
Number of intubation attempts 1 hour Observed during airway management
Successful ATI:FB 1 hour Number of participants with successful ATI:FB
Successful bronchoscopy 1 hour Number of participants with successful bronchoscopy
Successful tube placement 1 hour Number of participants with successful tracheal tube placement
Conversion from transnasal to transoral bronchoscopy or vice versa 1 hour Observed during airway management
Trial Locations
- Locations (1)
University Medical Center Hamburg-Eppendorf
🇩🇪Hamburg, Germany