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- Ensaio Clínico NCT04711499
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.
Visão geral do estudo
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Triagem
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
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The intervention will be assessing the participant in a fatigued state compared to a non fatigued state
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Comparador Ativo: 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
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The intervention will be assessing the participant in a fatigued state compared to a non fatigued state
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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composite error scoring within a regional anaesthesia performance task
Prazo: 6 months
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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.
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6 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Global rating score (GRS)
Prazo: 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.
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6 months
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Task completion time
Prazo: 6 months
|
Compare the mean time in seconds taken by the participants in Group F and Group A to complete the standardised UGRA task.
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6 months
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Reliability of the composite error score (CES) and global rating scale (GRS)
Prazo: 6 months
|
calculate the intra-class correlation (ICC) and Cronbach's alpha co-efficient and their associated standard error of the mean (SEM, %).
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6 months
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Eye tracking metrics
Prazo: 6 months
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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.
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6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: David Hewson, MBBS, University Hospitals of Nottingham
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Antecipado)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 20AN007
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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