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Patient Experience Following Awake Fibreoptic Intubation Compared to Asleep Fibreoptic Intubation

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ClinicalTrials.gov Identifier: NCT04091568
Recruitment Status : Not yet recruiting
First Posted : September 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Collaborator:
Oxford University Hospitals NHS Trust
Information provided by (Responsible Party):
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, we will investigate the occurrence of negative experiences, such as distress and discomfort.

Condition or disease
Tracheal Intubation Intubation;Difficult

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.

We 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.


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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Patients' Experience Following Awake and Asleep Fibreoptic Intubation
Estimated Study Start Date : September 20, 2019
Estimated Primary Completion Date : January 3, 2021
Estimated Study Completion Date : January 3, 2021

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Secondary endpoints include the differences in occurrence of patient discomfort, pain and difficulty breathing. [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091568


Contacts
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Contact: Cyprian Mendonca, MD,FRCA 02476 965871 Cyprian.Mendonca@uhcw.nhs.uk
Contact: Tim Davies, MBChB 02476 965871 Tim.Davies@uhcw.nhs.uk

Locations
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United Kingdom
University Hospitals Coventry & Warwickshire NHS Trust Recruiting
Coventry, West Midlands, United Kingdom, CV2 2DX
Contact: Cyprian Mendonca, MD    02476 965871    Cyprian.Mendonca@uhcw.nhs.uk   
Oxford University Hospitals Recruiting
Oxford, United Kingdom, OX3 7LE
Contact: Vassilis Athanssoglou    07971006906      
Sponsors and Collaborators
University Hospitals Coventry and Warwickshire NHS Trust
Oxford University Hospitals NHS Trust
Investigators
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Study Chair: Ceri Jones University Hospitals of Coventry and Warwickshire
Principal Investigator: Cyprian Mendonca, MD,FRCA University Hospitals of Coventry and Warwickshire

Publications:
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

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Responsible Party: University Hospitals Coventry and Warwickshire NHS Trust
ClinicalTrials.gov Identifier: NCT04091568     History of Changes
Other Study ID Numbers: 247165
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will be a written questionnaire which is anonymous

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospitals Coventry and Warwickshire NHS Trust:
Awake fibre-optic tracheal intubation
Asleep fibre-optic tracheal intubation
Patient experience