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- Klinische proef 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.
Studie Overzicht
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Screening
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
composite error scoring within a regional anaesthesia performance task
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Global rating score (GRS)
Tijdsspanne: 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
Tijdsspanne: 6 months
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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)
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: David Hewson, MBBS, University Hospitals of Nottingham
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 20AN007
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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