Effect of Fatigue on Regional Anaesthesia Task

Study Overview
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Brief Summary
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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.

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

Conditions
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Fatigue, Anesthesia

Intervention / Treatment
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* Behavioral: Fatigue


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fatigue Group<br>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<br>* The intervention will be assessing the participant in a fatigued state compared to a non fatigued state<br>|
| Active Comparator: Non Fatigued group<br>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<br>* The intervention will be assessing the participant in a fatigued state compared to a non fatigued state<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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regional anaesthesia, patient safety, nerve blockade, ultrasound guided needling