search
Back to results

Effect of Fatigue on Regional Anaesthesia Task

Primary Purpose

Fatigue, Anesthesia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fatigue
Sponsored by
Nottingham University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Fatigue focused on measuring regional anaesthesia, patient safety, nerve blockade, ultrasound guided needling

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

1. Anaesthetists of ST3 grade and above with previous experience of performing an ultrasound guided peripheral nerve block.

Exclusion Criteria:

  1. Previous experience of gaze control training or eye-tracking software applied to medical interventions.
  2. No previous experience of performing an ultrasound guided peripheral nerve block.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Fatigue Group

    Non Fatigued group

    Arm Description

    The trial will recruit trainee anaesthetists of ST3 grade or higher who take part in a resident night-shift rota at Nottingham University Hospitals NHS Trust. Participants will undergo baseline psychometric testing to measure baseline mood. There will be a series of questions to ascertain levels of fatigue. All participants will then be asked to perform a standardised ultrasound-guided peripheral nerve blockade task using a high fidelity bench-top phantom model. Performance in this task will be independently assessed using a previously-validated scoring tool by two raters blinded to participant group allocation.

    The non fatigued group will be asked to perform the same series of questions and tasks after a night at home with no work duties or commitments

    Outcomes

    Primary Outcome Measures

    composite error scoring within a regional anaesthesia performance task
    establish a comparison of mean composite error scores (CES) between participants in group F (fatigued state) and Group A (non-fatigued state) when performing a standardised ultrasound guided regional anaesthesia task. CES can range from 0 to 100. the higher the score the more negative the performance of the candidate.

    Secondary Outcome Measures

    Global rating score (GRS)
    establish a comparison of mean Global rating scale (GRS) between participants in group F (fatigued state) and Group A (non-fatigued state) when performing a standardised ultrasound guided regional anaesthesia task. The GRS ranges from a score of 7 to a score of 35. The higher the score the better the performance.
    Task completion time
    Compare the mean time in seconds taken by the participants in Group F and Group A to complete the standardised UGRA task.
    Reliability of the composite error score (CES) and global rating scale (GRS)
    calculate the intra-class correlation (ICC) and Cronbach's alpha co-efficient and their associated standard error of the mean (SEM, %).
    Eye tracking metrics
    All eye tracking-derived secondary outcome measures listed below will be calculated (and summed to create a total) for each UGRA assessment using the following pre-defined areas of interest: the ultrasound machine screen ('US screen'); their hands, the needle, the US transducer or the cadaveric model ('tools'); and any other area outside the US screen or tools ('other'). This is measures on a numerical scale on the number of times there is deviation and gaze away from the screen. The lower the number the better the performance by the candidate.

    Full Information

    First Posted
    October 23, 2020
    Last Updated
    January 14, 2021
    Sponsor
    Nottingham University Hospitals NHS Trust
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04711499
    Brief Title
    Effect of Fatigue on Regional Anaesthesia Task
    Official Title
    The Effect of Fatigue on Regional Anaesthesia Task Performance Among Anaesthetists: a Rater-blinded Randomised Controlled Crossover Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2021 (Anticipated)
    Primary Completion Date
    June 1, 2021 (Anticipated)
    Study Completion Date
    June 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nottingham University Hospitals NHS Trust

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The adverse effects of sleep related fatigue are significant, impacting on doctors' health, wellbeing, performance and ultimately their safety and that of their patients'. Trainees are at an increased risk of fatigue because they routinely, and are increasingly, working long hours, and exposed to excessive and high intensity workloads. With increasing numbers of patient consultations, there is a higher risk of making poorer quality clinical decisions (i.e. decision fatigue). The excessive workloads experienced by doctors can cause fatigue through the requirement for sustained attention over long periods of time, particularly when performing complex and mentally demanding tasks. Our main objective is to study the difference between the fatigued and non-fatigued state of anaesthetists and on their ability to perform an ultrasound-guided peripheral nerve blockade task. We hypothesise that fatigue will result in a clinically significant reduction in the objective structured assessment scores of anaesthetists who are performing an ultrasound-guided peripheral nerve blockade task compared to their scores when they are non-fatigued.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fatigue, Anesthesia
    Keywords
    regional anaesthesia, patient safety, nerve blockade, ultrasound guided needling

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Fatigue Group
    Arm Type
    Experimental
    Arm Description
    The trial will recruit trainee anaesthetists of ST3 grade or higher who take part in a resident night-shift rota at Nottingham University Hospitals NHS Trust. Participants will undergo baseline psychometric testing to measure baseline mood. There will be a series of questions to ascertain levels of fatigue. All participants will then be asked to perform a standardised ultrasound-guided peripheral nerve blockade task using a high fidelity bench-top phantom model. Performance in this task will be independently assessed using a previously-validated scoring tool by two raters blinded to participant group allocation.
    Arm Title
    Non Fatigued group
    Arm Type
    Active Comparator
    Arm Description
    The non fatigued group will be asked to perform the same series of questions and tasks after a night at home with no work duties or commitments
    Intervention Type
    Behavioral
    Intervention Name(s)
    Fatigue
    Intervention Description
    The intervention will be assessing the participant in a fatigued state compared to a non fatigued state
    Primary Outcome Measure Information:
    Title
    composite error scoring within a regional anaesthesia performance task
    Description
    establish a comparison of mean composite error scores (CES) between participants in group F (fatigued state) and Group A (non-fatigued state) when performing a standardised ultrasound guided regional anaesthesia task. CES can range from 0 to 100. the higher the score the more negative the performance of the candidate.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Global rating score (GRS)
    Description
    establish a comparison of mean Global rating scale (GRS) between participants in group F (fatigued state) and Group A (non-fatigued state) when performing a standardised ultrasound guided regional anaesthesia task. The GRS ranges from a score of 7 to a score of 35. The higher the score the better the performance.
    Time Frame
    6 months
    Title
    Task completion time
    Description
    Compare the mean time in seconds taken by the participants in Group F and Group A to complete the standardised UGRA task.
    Time Frame
    6 months
    Title
    Reliability of the composite error score (CES) and global rating scale (GRS)
    Description
    calculate the intra-class correlation (ICC) and Cronbach's alpha co-efficient and their associated standard error of the mean (SEM, %).
    Time Frame
    6 months
    Title
    Eye tracking metrics
    Description
    All eye tracking-derived secondary outcome measures listed below will be calculated (and summed to create a total) for each UGRA assessment using the following pre-defined areas of interest: the ultrasound machine screen ('US screen'); their hands, the needle, the US transducer or the cadaveric model ('tools'); and any other area outside the US screen or tools ('other'). This is measures on a numerical scale on the number of times there is deviation and gaze away from the screen. The lower the number the better the performance by the candidate.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 1. Anaesthetists of ST3 grade and above with previous experience of performing an ultrasound guided peripheral nerve block. Exclusion Criteria: Previous experience of gaze control training or eye-tracking software applied to medical interventions. No previous experience of performing an ultrasound guided peripheral nerve block.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    David W Hewson, MBBS
    Phone
    01159249924
    Ext
    61195
    Email
    david.hewson@nottingham.ac.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Farhaan Moosa, MBCHB
    Phone
    01159249924
    Ext
    61195
    Email
    farhaanmoosa@yahoo.co.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Hewson, MBBS
    Organizational Affiliation
    University Hospitals of Nottingham
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect of Fatigue on Regional Anaesthesia Task

    We'll reach out to this number within 24 hrs