Patient Experience of Transoral Versus Transnasal Awake Tracheal Intubation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Airway Management; Patient Experience; Fiberoptic Guided Intubation

• Study Type: Observational
• Enrollment (Estimated): 198

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Recruiting
    • University Medical Center Hamburg-Eppendorf
    • Contact: Martin Petzoldt, M.D.; Phone Number: +4915222815932; Email: m.petzoldt@uke.de
    • Contact: Vera Köhl, M.D.; Email: v.koehl@uke.de
    • Principal Investigator: Martin Petzoldt, M.D.
    • Sub-Investigator: Vera Köhl, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients scheduled for surgery requiring general anaesthesia at the study center university hospital medical center

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Transnasal ATI:FB; Patients undergoing airway management via the transnasal route
Transoral ATI:FB; Patients undergoing airway management via the transoral route

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported discomfort experienced during ATI:FB	recorded on a visual analog scale (1-100; lower values better)	24 hours after anaesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of intubation attempts	Observed during airway management	1 hour
Number of bronchoscopy attempts	Observed during airway management	1 hour
Successful ATI:FB	Number of participants with successful ATI:FB	1 hour
Successful bronchoscopy	Number of participants with successful bronchoscopy	1 hour
Successful tube placement	Number of participants with successful tracheal tube placement	1 hour
Conversion from transnasal to transoral bronchoscopy or vice versa	Observed during airway management	1 hour
Percentage of glottic opening	Grading of the best view obtained during laryngoscopy (%)	1 hour
Lowest oxygen saturation	Measured during airway management (%)	1 hour
Preparation time	Recorded during airway management	1 hour
Patient reported recall of the ATI:FB	yes/no and on a visual analog scale (1-100; lower values better)	24 hours after airway management
Patient reported pain experienced during ATI:FB	yes/no and on a visual analog scale (1-100; lower values better)	24 hours after airway management
Patient reported fear experienced during ATI:FB	yes/no and on a visual analog scale (1-100; lower values better)	24 hours after airway management
Patient reported feeling of suffocation experienced during ATI:FB	yes/no and on a visual analog scale (1-100; lower values better)	24 hours after airway management
Patient reported dyspnea experienced during ATI:FB	yes/no and on a visual analog scale (1-100; lower values better)	24 hours after airway management
Patient reported distress experienced during ATI:FB	yes/no and on a visual analog scale (1-100; lower values better)	24 hours after airway management
Patient reported coughing experienced after ATI:FB	yes/no and on a visual analog scale (1-100; lower values better)	24 hours after airway management
Patient reported dry throat experienced after ATI:FB?	yes/no and on a visual analog scale (1-100; lower values better)	24 hours after airway management
Patient reported hoarseness experienced after ATI:FB	yes/no and on a visual analog scale (1-100; lower values better)	24 hours after airway management
Patient reported sleeping problems experienced after ATI:FB	yes/no and on a visual analog scale (1-100; lower values better)	24 hours after airway management
Patient reported occurrence of nightmares experienced after ATI:FB	yes/no and on a visual analog scale (1-100; lower values better)	24 hours after airway management
Patient reported preoperative expectation of discomfort to be experienced during ATI:FB	yes/no and on a visual analog scale (1-100; lower values better)	during preoperative assessment
Patient reported preoperative fear of airway management	yes/no and on a visual analog scale (1-100; lower values better)	during preoperative assessment
First attempt success	number of participants with successful ATI:FB with only one attempt	1 hour
Conversion to another type of airway management	Observed during airway management	1 hour
Glottic view	Grading of the best view obtained using landmarks (6 stages)	1 hour
Time to best glottic view	Recorded during airway management	1 hour
Time to intubation	Recorded during airway management	1 hour
Endtidal CO2	First value measured after intubation in mmHg	1 hour
Airway obstructions requiring external manipulation	yes/no	1 hour
Hypoxia	Lowest peripheral oxygen saturation measured by pulsoximetry in %	1 hour
Cardiovascular event requiring intervention (hypotension/bradycardia)	Observed during airway management	1 hour
Cardiovascular event requiring intervention (hypertension, tachycardia)	Observed during airway management	1 hour
Additional manoeuvres and adjuncts	Observed during airway management	1 hour
Airway-related complications	Recorded during airway management	1 hour
Anaesthesia alert card issue	Recorded after airway management	1 hour
Recommendation for future airway management	Recorded after airway management	1 hour
Richmond Agitation-Sedation Scale	Observed during airway management (-5 to 4; lower values indicate deeper sedation)	1 hour
Subjective reporting of difficulty of sedation, topicalisation, bronchoscopy and tube placement	On a visual analog scale (1-100)	1 hour

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2025
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): December 15, 2025

Study Registration Dates

• First Submitted: April 22, 2025
• First Submitted That Met QC Criteria: May 1, 2025
• First Posted (Actual): May 2, 2025

Study Record Updates

• Last Update Posted (Actual): July 10, 2025
• Last Update Submitted That Met QC Criteria: July 7, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: airway management; flexible endoscopy guided intubation; patient discomfort
• Other Study ID Numbers: 2025-101503-BO-ff

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No