Effect of Fatigue on Regional Anaesthesia Task

NCT04711499 | Unknown

• 1 other identifier: 20AN007
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fatigue; Anesthesia

Keywords

regional anaesthesia; patient safety; nerve blockade; ultrasound guided needling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Global rating score (GRS)

  6 months

• Task completion time

  6 months

• Reliability of the composite error score (CES) and global rating scale (GRS)

  6 months

• Eye tracking metrics

  6 months

Study Arms (2)

Fatigue Group

EXPERIMENTAL

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

Non Fatigued group

ACTIVE COMPARATOR

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

Interventions

Fatigue BEHAVIORAL

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

Fatigue Group; Non Fatigued group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Hewson, MBBS

  University Hospitals of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David W Hewson, MBBS

CONTACT

01159249924; david.hewson@nottingham.ac.uk

Farhaan Moosa, MBCHB

CONTACT

01159249924; farhaanmoosa@yahoo.co.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: January 15, 2021
• Study Start: February 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: January 15, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share