Effect of Fatigue on Regional Anaesthesia Task

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04711499
• Other study ID #: 20AN007
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: June 1, 2021

Study information

• Verified date: September 2020
• Source: Nottingham University Hospitals NHS Trust
• Contact: David W Hewson, MBBS
• Phone: 01159249924
• Email: david.hewson[@]nottingham.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Fatigue

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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