Tracheal IntubationNCT04091568
Patient Experience Following Awake Fibreoptic Intubation Compared to Asleep Fibreoptic Intubation
An observational study of Tracheal Intubation and Intubation;Difficult, run by University Hospitals Coventry and Warwickshire NHS Trust at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tracheal Intubation, Intubation;Difficult
- How many people
- 130 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 10 Oct 2019to 6 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, West Midlands, CV2 2DX
Oxford University Hospitals
Oxford, OX3 7LE
About this study
Official title: 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.
Read the 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.
- Conditions
- Tracheal Intubation, Intubation;Difficult
- Keywords
- Awake fibre-optic tracheal intubation, Asleep fibre-optic tracheal intubation, Patient experience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Awake fibre-optic intubation | Awake fibre-optic intubation | |
| Asleep fibre-optic intubation | Asleep fibre-optic intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 - 12 months
Secondary outcomes (1)
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.
Measured: 6 - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start10 Oct 2019
- Primary completion6 Nov 2020
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Tracheal IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Ceri Jones, Study chair, University Hospitals of Coventry and WarwickshireCyprian Mendonca, MD,FRCA, Principal investigator, University Hospitals of Coventry and Warwickshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091568
- Sponsor's protocol ID
- 247165
- Status last verified
- May 2021
- First submitted
- 13 Sep 2019
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be a written questionnaire which is anonymous
Publications
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.
PubMed 26556848Cook 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.
PubMed 21447488Allan 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.
PubMed 15023129Patil 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.
PubMed 12393360Wanderer 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.
PubMed 23897492Wiles 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.
PubMed 11159261McNarry 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.
PubMed 17207298El-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.
PubMed 28654138Mavridou 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.
PubMed 22864564Schnack 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.
PubMed 21544021Knudsen 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.
PubMed 27576876
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Patients' Experience Following Awake and Asleep Fibreoptic Intubation
- ClinicalTrials.gov ID
- NCT04091568
- Acronym / sponsor ID
- 247165
- Conditions
- Tracheal Intubation, Intubation;Difficult
- Keywords
- Awake fibre-optic tracheal intubation, Asleep fibre-optic tracheal intubation, Patient experience
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Awake fibre-optic intubation | – | –Awake fibre-optic intubation |
| Asleep fibre-optic intubation | – | –Asleep fibre-optic intubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the incidence and severity of distress experienced by patients during awake and asleep fibreoptic intubation.
Time frame: 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.
1 secondary outcome
Secondary endpoints include the differences in occurrence of patient discomfort, pain and difficulty breathing.
Time frame: 6 - 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Background: PubMed 26556848Frerk 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.
- Background: PubMed 21447488Cook 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.
- Background: PubMed 15023129Allan 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.
- Background: PubMed 12393360Patil 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.
- Background: PubMed 23897492Wanderer 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.
- BackgroundWiles 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: PubMed 11159261Heidegger 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.
- Background: PubMed 17207298McNarry 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.
- Background: PubMed 28654138El-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.
- Background: PubMed 22864564Mavridou 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.
- Background: PubMed 21544021Schnack 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.
- Background: PubMed 27576876Knudsen 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.
- Individual participant dataSharing planned: No. IPD will be a written questionnaire which is anonymous
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ceri Jones study chair
University Hospitals of Coventry and Warwickshire
Cyprian Mendonca, MD,FRCA principal investigator
University Hospitals of Coventry and Warwickshire
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheal Intubation and Intubation;Difficult, run by University Hospitals Coventry and Warwickshire NHS Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the incidence and severity of distress experienced by patients during awake and asleep fibreoptic intubation. (time frame: 6 - 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04091568, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.