Patient Experience Following Awake Fibreoptic Intubation Compared to Asleep Fibreoptic Intubation

NCT04091568 | Completed DMC

• 1 other identifier: 247165
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 2

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.

Conditions

Tracheal Intubation; Intubation;Difficult

Keywords

Awake fibre-optic tracheal intubation; Asleep fibre-optic tracheal intubation; Patient experience

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary endpoints include the differences in occurrence of patient discomfort, pain and difficulty breathing.

  6 - 12 months

Study Arms (2)

Awake fibre-optic intubation

Awake fibre-optic intubation

Asleep fibre-optic intubation

Asleep fibre-optic intubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead
• Oxford University Hospitals NHS Trust: collaborator

Study Sites (2)

University Hospitals Coventry & Warwickshire NHS Trust

Coventry, West Midlands, CV2 2DX, United Kingdom

Location

Oxford University Hospitals

Oxford, OX3 7LE, United Kingdom

Location

Related Publications (12)

• 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.

  PMID: 26556848 BACKGROUND

• 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.

  PMID: 21447488 BACKGROUND

• 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.

  PMID: 15023129 BACKGROUND

• 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.

  PMID: 12393360 BACKGROUND

• 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.

  PMID: 23897492 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 11159261 BACKGROUND

• 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.

  PMID: 17207298 BACKGROUND

• 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.

  PMID: 28654138 BACKGROUND

• 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.

  PMID: 22864564 BACKGROUND

• 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.

  PMID: 21544021 BACKGROUND

• 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.

  PMID: 27576876 BACKGROUND

Study Officials

• Ceri Jones

  University Hospitals of Coventry and Warwickshire

  STUDY CHAIR

• Cyprian Mendonca, MD,FRCA

  University Hospitals of Coventry and Warwickshire

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 17, 2019
• Study Start: October 10, 2019
• Primary Completion: November 6, 2020
• Study Completion: November 6, 2020
• Last Updated: May 5, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)