Effect of Fatigue on Regional Anaesthesia Task

The Effect of Fatigue on Regional Anaesthesia Task Performance Among Anaesthetists: a Rater-blinded Randomised Controlled Crossover Trial

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.

Study Overview

• Status: Unknown
• Conditions: Fatigue; Anesthesia
• Intervention / Treatment: Behavioral: Fatigue

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
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.	6 months
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, %).	6 months
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.	6 months

Collaborators and Investigators

• Sponsor: Nottingham University Hospitals NHS Trust
• Investigators: Principal Investigator: David Hewson, MBBS, University Hospitals of Nottingham

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 14, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: regional anaesthesia; patient safety; nerve blockade; ultrasound guided needling
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: 20AN007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No