Patient Experience Following Awake Fibreoptic Intubation Compared to Asleep Fibreoptic Intubation

Completed

• Conditions: Intubation;Difficult; Tracheal Intubation

• Registration Number: NCT04091568
• Lead Sponsor: University Hospitals Coventry and Warwickshire NHS Trust

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.

Study Timeline

• Study First Submitted: 2019-09-13
• Study First Submitted QC: 2019-09-13
• Study First Posted: 2019-09-17
• Study Start: 2019-10-10
• Primary Completion: 2020-11-06
• Study Completion: 2020-11-06
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-04
• Last Update Posted: 2021-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the incidence and severity of distress experienced by patients during awake and asleep fibreoptic intubation.	6 - 12 months	Participants will be asked to rate the discomfort during the procedure on a Visual Analogue Score (0-10). There will also be space for patients to write comments explaining their score. These comments will then be used for content analysis, for example to explore different aspects of the procedure that caused distress.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints include the differences in occurrence of patient discomfort, pain and difficulty breathing.	6 - 12 months	This will be assessed through the patient experience questionnaire, with a mixture of direct questions and the request for more detailed information regarding these answers.

Trial Locations

Locations (2)

University Hospitals Coventry & Warwickshire NHS Trust; 🇬🇧 Coventry, West Midlands, United Kingdom

Oxford University Hospitals; 🇬🇧 Oxford, United Kingdom