Patient Experience Following Awake Fibreoptic Intubation Compared to Asleep Fibreoptic Intubation

Intubation;Difficult Clinical Trial

Official title:

Comparison of Patients' Experience Following Awake and Asleep Fibreoptic Intubation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04091568
• Other study ID #: 247165
• Status: Completed
• Start date: October 10, 2019
• Est. completion date: November 6, 2020

Study information

• Verified date: May 2021
• Source: University Hospitals Coventry and Warwickshire NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: November 6, 2020
• Est. primary completion date: November 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intubation;Difficult
• Tracheal Intubation

Locations

Country	Name	City	State
United Kingdom	University Hospitals Coventry & Warwickshire NHS Trust	Coventry	West Midlands
United Kingdom	Oxford University Hospitals	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Coventry and Warwickshire NHS Trust	Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (12)

Allan AG. Reluctance of anaesthetists to perform awake intubation. Anaesthesia. 2004 Apr;59(4):413. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Heidegger T, Gerig HJ, Ulrich B, Kreienbühl 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. — View Citation

Knudsen K, Nilsson U, Högman M, Pöder 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. — View Citation

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. — View Citation

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. Epub 2007 Jan 8. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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