Patient Experience of Transoral Versus Transnasal Awake Tracheal Intubation

NCT06955884 | Recruiting

• 1 other identifier: 2025-101503-BO-ff
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Management; Fiberoptic Guided Intubation; Patient Experience

Keywords

airway management; flexible endoscopy guided intubation; patient discomfort

Outcome Measures

Primary Outcomes (1)

• Patient reported discomfort experienced during ATI:FB

  recorded on a visual analog scale (1-100; lower values better)

  24 hours after anaesthesia

Secondary Outcomes (38)

• Patient reported recall of the ATI:FB

  24 hours after airway management

• Patient reported pain experienced during ATI:FB

  24 hours after airway management

• Patient reported fear experienced during ATI:FB

  24 hours after airway management

• Patient reported feeling of suffocation experienced during ATI:FB

  24 hours after airway management

• Patient reported dyspnea experienced during ATI:FB

  24 hours after airway management

Study Arms (2)

Transnasal ATI:FB

Patients undergoing airway management via the transnasal route

Transoral ATI:FB

Patients undergoing airway management via the transoral route

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Hamburg, 20246, Germany

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 2, 2025
• Study Start: June 30, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 15, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)