Patient Experience of Transoral Versus Transnasal Awake Tracheal Intubation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitätsklinikum Hamburg-Eppendorf

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

198 Participants
are grouped into 2 trial groups
Group A: Transnasal ATI:FB
Group B: Transoral ATI:FB

Trial outcomes

Primary outcomes

1

Patient reported discomfort experienced during ATI:FB

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

Time frame
24 hours after anaesthesia

Secondary outcomes

1

Patient reported recall of the ATI:FB

yes/no and on a visual analog scale (1-100; lower values better)

Time frame
24 hours after airway management
2

Patient reported pain experienced during ATI:FB

yes/no and on a visual analog scale (1-100; lower values better)

Time frame
24 hours after airway management
3

Patient reported fear experienced during ATI:FB

yes/no and on a visual analog scale (1-100; lower values better)

Time frame
24 hours after airway management
4

Patient reported feeling of suffocation experienced during ATI:FB

yes/no and on a visual analog scale (1-100; lower values better)

Time frame
24 hours after airway management

Other outcomes

Sponsors and contacts

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