Clinical trial NCT04091568: Patient Experience Following Awake Fibreoptic Intubation Compared to Asleep Fibreoptic Intubation
Official title: Comparison of Patients' Experience Following Awake and Asleep Fibreoptic Intubation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tracheal Intubation
Intubation;Difficult
Keywords: Awake fibre-optic tracheal intubation
Asleep fibre-optic tracheal intubation
Patient experience
Lead sponsor: University Hospitals Coventry and Warwickshire NHS Trust
Sponsor class: OTHER
Collaborators: name: Oxford University Hospitals NHS Trust
First posted: 2019-09-17
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those patients who undergo either awake or asleep fibreoptic intubation in the Head and Neck Theatres at both UHCW and Oxford University Hospitals Foundation Trust, as decided by their responsible anaesthetist.

Brief summary: The aim of this observational study is to explore and compare patients' experiences of asleep and awake fibreoptic intubation using a semi qualitative patient questionnaire. In particular, investigators will investigate the occurrence of negative experiences, such as distress and discomfort.

Detailed description: This study aims to investigate whether there are significant differences in aspects of patient experience during AFOI and asleep fibreoptic intubation. The study will be conducted at University Hospitals Coventry and Warwickshire NHS Trust and Oxford University Hospitals Foundation Trust.

Investigators are not aware of any studies to date comparing patient experiences of AFOI with asleep fibreoptic intubation to ascertain the significant differences in side effects. If there is no evidence of any significant difference in negative patient experiences, this might help to encourage anaesthetists to reduce their threshold for AFOI and to use this as first choice for anticipated difficult airway management.

A member of the research team will approach the patient about the study and obtain written informed consent, if the patient is willing and able to participate. The participant will be provided with a specifically designed questionnaire, covering several aspects of patient experience. A mixture of free response answers and numerical rating scales will be used. The member of the research team approaching the patient with the questionnaire will be blinded to the intubation procedure, ensuring consistent application of the questionnaire and minimising bias. This will then be the end of the study for the participant.

Eligibility criteria: Inclusion Criteria:

* All patients aged 18 years and above
* Patients who underwent head and neck or dental surgery and required awake or asleep fibreoptic intubation
* Patients who underwent elective surgery
* Are able and willing to provide written informed consent

Exclusion Criteria:

* Patients who do not consent to be part of the study
* Patients below 18 years old If a translator is not available at the time, participants who cannot reasonably read and communicate in English
* Those who did not undergo awake or asleep fibreoptic intubation
* Those who underwent emergency surgery

Primary outcomes:
measure: To assess the incidence and severity of distress experienced by patients during awake and asleep fibreoptic intubation.
timeFrame: 6 - 12 months
Secondary outcomes:
measure: Secondary endpoints include the differences in occurrence of patient discomfort, pain and difficulty breathing.
timeFrame: 6 - 12 months
Other outcomes:
Locations:
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry & Warwickshire NHS Trust
state: West Midlands
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals
Study officials:
affiliation: University Hospitals of Coventry and Warwickshire
name: Ceri Jones
role: STUDY_CHAIR
affiliation: University Hospitals of Coventry and Warwickshire
name: Cyprian Mendonca, MD,FRCA
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Knudsen K, Nilsson U, Hogman M, Poder U. Awake intubation creates feelings of being in a vulnerable situation but cared for in safe hands: a qualitative study. BMC Anesthesiol. 2016 Aug 30;16(1):71. doi: 10.1186/s12871-016-0240-z.