Patient Experience Following Awake Fibreoptic Intubation Compared to Asleep Fibreoptic Intubation

Sponsor
University Hospitals Coventry and Warwickshire NHS Trust (Other)
Overall Status
Completed
CT.gov ID
NCT04091568
Collaborator
Oxford University Hospitals NHS Trust (Other)
130
2
12.9
65
5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    130 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Comparison of Patients' Experience Following Awake and Asleep Fibreoptic Intubation
    Actual Study Start Date :
    Oct 10, 2019
    Actual Primary Completion Date :
    Nov 6, 2020
    Actual Study Completion Date :
    Nov 6, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Awake fibre-optic intubation

    Awake fibre-optic intubation

    Asleep fibre-optic intubation

    Asleep fibre-optic intubation

    Outcome Measures

    Primary Outcome Measures

    1. To assess the incidence and severity of distress experienced by patients during awake and asleep fibreoptic intubation. [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. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospitals Coventry & Warwickshire NHS Trust Coventry West Midlands United Kingdom CV2 2DX
    2 Oxford University Hospitals Oxford United Kingdom OX3 7LE

    Sponsors and Collaborators

    • University Hospitals Coventry and Warwickshire NHS Trust
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University Hospitals Coventry and Warwickshire NHS Trust
    ClinicalTrials.gov Identifier:
    NCT04091568
    Other Study ID Numbers:
    • 247165
    First Posted:
    Sep 17, 2019
    Last Update Posted:
    May 5, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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

    Study Results

    No Results Posted as of May 5, 2021