Effect of Fatigue on Regional Anaesthesia Task

Sponsor
Nottingham University Hospitals NHS Trust (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04711499
Collaborator
(none)
32
2
3.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Fatigue
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Screening
Official Title:
The Effect of Fatigue on Regional Anaesthesia Task Performance Among Anaesthetists: a Rater-blinded Randomised Controlled Crossover Trial
Anticipated Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fatigue Group

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.

Behavioral: Fatigue
The intervention will be assessing the participant in a fatigued state compared to a non fatigued state

Active Comparator: Non Fatigued group

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

Behavioral: Fatigue
The intervention will be assessing the participant in a fatigued state compared to a non fatigued state

Outcome Measures

Primary Outcome Measures

  1. composite error scoring within a regional anaesthesia performance task [6 months]

    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

  1. Global rating score (GRS) [6 months]

    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.

  2. Task completion time [6 months]

    Compare the mean time in seconds taken by the participants in Group F and Group A to complete the standardised UGRA task.

  3. Reliability of the composite error score (CES) and global rating scale (GRS) [6 months]

    calculate the intra-class correlation (ICC) and Cronbach's alpha co-efficient and their associated standard error of the mean (SEM, %).

  4. Eye tracking metrics [6 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Nottingham University Hospitals NHS Trust

Investigators

  • Principal Investigator: David Hewson, MBBS, University Hospitals of Nottingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT04711499
Other Study ID Numbers:
  • 20AN007
First Posted:
Jan 15, 2021
Last Update Posted:
Jan 15, 2021
Last Verified:
Sep 1, 2020
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 Nottingham University Hospitals NHS Trust
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 15, 2021