Patient Experience Following Awake Fibreoptic Intubation Compared to Asleep Fibreoptic Intubation

Comparison of Patients' Experience Following Awake and Asleep Fibreoptic Intubation

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.

Study Overview

• Status: Completed
• Conditions: Intubation;Difficult; Tracheal Intubation

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 Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX3 7LE
    • Oxford University Hospitals
  • West Midlands
    • Coventry, West Midlands, United Kingdom, CV2 2DX
      • University Hospitals Coventry & Warwickshire NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Awake fibre-optic intubation
Asleep fibre-optic intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the incidence and severity of distress experienced by patients during awake and asleep fibreoptic intubation.	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.	6 - 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary endpoints include the differences in occurrence of patient discomfort, pain and difficulty breathing.	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.	6 - 12 months

Collaborators and Investigators

• Sponsor: University Hospitals Coventry and Warwickshire NHS Trust
• Collaborators: Oxford University Hospitals NHS Trust
• Investigators: Study Chair: Ceri Jones, University Hospitals of Coventry and Warwickshire; Principal Investigator: Cyprian Mendonca, MD,FRCA, University Hospitals of Coventry and Warwickshire

Publications and helpful links

General Publications

• Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29.
• Frerk C, Mitchell VS, McNarry AF, Mendonca C, Bhagrath R, Patel A, O'Sullivan EP, Woodall NM, Ahmad I; Difficult Airway Society intubation guidelines working group. Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubation in adults. Br J Anaesth. 2015 Dec;115(6):827-48. doi: 10.1093/bja/aev371. Epub 2015 Nov 10.
• Mavridou P, Dimitriou V, Manataki A, Arnaoutoglou E, Papadopoulos G. Patient's anxiety and fear of anesthesia: effect of gender, age, education, and previous experience of anesthesia. A survey of 400 patients. J Anesth. 2013 Feb;27(1):104-8. doi: 10.1007/s00540-012-1460-0. Epub 2012 Aug 3.
• Allan AG. Reluctance of anaesthetists to perform awake intubation. Anaesthesia. 2004 Apr;59(4):413. doi: 10.1111/j.1365-2044.2004.03729.x. No abstract available.
• Patil V, Barker GL, Harwood RJ, Woodall NM. Training course in local anaesthesia of the airway and fibreoptic intubation using course delegates as subjects. Br J Anaesth. 2002 Oct;89(4):586-93. doi: 10.1093/bja/aef226.
• Wanderer JP, Ehrenfeld JM, Sandberg WS, Epstein RH. The changing scope of difficult airway management. Can J Anaesth. 2013 Oct;60(10):1022-4. doi: 10.1007/s12630-013-9999-2. Epub 2013 Jul 30. No abstract available.
• Wiles MD, McCahon RA, Armstrong JAM. Fibreoptic intubation rates in a UK teaching hospital. Proceedings of the Anaesthetic Research Society Meeting. Br J Anaesth 2010; 105 (5): 729P
• Heidegger T, Gerig HJ, Ulrich B, Kreienbuhl G. Validation of a simple algorithm for tracheal intubation: daily practice is the key to success in emergencies--an analysis of 13,248 intubations. Anesth Analg. 2001 Feb;92(2):517-22. doi: 10.1097/00000539-200102000-00044.
• McNarry AF, Dovell T, Dancey FM, Pead ME. Perception of training needs and opportunities in advanced airway skills: a survey of British and Irish trainees. Eur J Anaesthesiol. 2007 Jun;24(6):498-504. doi: 10.1017/S0265021506002031. Epub 2007 Jan 8.
• El-Boghdadly K, Onwochei DN, Cuddihy J, Ahmad I. A prospective cohort study of awake fibreoptic intubation practice at a tertiary centre. Anaesthesia. 2017 Jun;72(6):694-703. doi: 10.1111/anae.13844.
• Schnack DT, Kristensen MS, Rasmussen LS. Patients' experience of awake versus anaesthetised orotracheal intubation: a controlled study. Eur J Anaesthesiol. 2011 Jun;28(6):438-42. doi: 10.1097/EJA.0b013e328343222d.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2019
• Primary Completion (Actual): November 6, 2020
• Study Completion (Actual): November 6, 2020

Study Registration Dates

• First Submitted: September 13, 2019
• First Submitted That Met QC Criteria: September 13, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Actual): May 5, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Patient experience; Awake fibre-optic tracheal intubation; Asleep fibre-optic tracheal intubation
• Other Study ID Numbers: 247165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD will be a written questionnaire which is anonymous

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No