- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04426227
Gaze Training on Task Performance Regional Anaesthesia
The Effect of Gaze Training on Task Performance and Skill Acquisition in Ultrasound-guided Regional Anaesthesia: a Partially Blinded Randomised Controlled Trial.
Regional anaesthesia is the performance of spinal, epidural or peripheral nerve blocks to allow patients to undergo surgery awake and to provide post-operative pain relief. Anaesthetists inject local anaesthetic using specialist needles close to nerves to prevent transmission of pain. Hand-held ultrasound is often used by anaesthetists to direct these needles to the correct position i.e. close to, but not in the nerve itself. If the needle is not adequately seen using the hand-held ultrasound it may pierce the nerve causing permanent nerve damage and significant patient harm.
Within the time and resource constraints of postgraduate medical training, it would be advantageous to optimise expertise acquisition of practical skills with a cheap, self-directed educational intervention. Therefore, the aim of this study is to determine whether gaze training is associated with improved performance of an ultrasound-guided needle task. The investigators hypothesise that improved gaze control will translate to better technical performance of an ultrasound-guided regional anaesthesia task.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- Phase 3
Contacts et emplacements
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Undergraduate Science, Technology, Engineering or Maths (STEM) students who are capable of giving informed consent
Exclusion Criteria:
- Previous experience of gaze training or eye tracking software
- Previous experience of regional anaesthesia needling tasks
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Group Gaze
The gaze-trained group will be shown a video, derived from the eye tracker, of an expert's visual control whilst performing the ultrasound task.
Participants will be made aware of the target-focused gaze strategy (lengthy and stable fixations on the needling target), and the manner in which the gaze shifted from target to tools (hands, needle and transducer) in a fast, smooth fashion.
They will then be advised to try to mimic the gaze strategy of the expert while undertaking the needling task as their first training task.
After completion of this training task, participants will be shown their own video data, as captured by the eye tracker.
Participants will be asked to comment on differences between their own video and the expert video they had previously seen.
This feedback process will be replicated a further four training task attempts.
Participants in this group will therefore undergo a total of five training attempts of the needling task.
|
A training module in gaze training for peripheral nerve blockade
|
|
Comparateur actif: Group Discovery
The discovery learning group will be given no video feedback and will be instructed to perform five training attempts at the needling task without further training or feedback.
|
A phase of discovery learning guided by novice operators themselves
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Composite Error Score
Délai: Undertaken during ultrasound assessment 1 (before training intervention) and during ultrasound assessment 2 (which will occur 10 minutes after the training intervention was undertaken). Each assessment will be 15 minutes in duration.
|
Objective error scoring of performance at needling task
|
Undertaken during ultrasound assessment 1 (before training intervention) and during ultrasound assessment 2 (which will occur 10 minutes after the training intervention was undertaken). Each assessment will be 15 minutes in duration.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Global Rating Scale
Délai: Undertaken during ultrasound assessment 1 (before training intervention) and during ultrasound assessment 2 (which will occur 10 minutes after the training intervention). Each assessment will be 15 minutes in duration.
|
Objective performance scoring of needling task, scored from 0-35, higher scores indicating better task performance.
|
Undertaken during ultrasound assessment 1 (before training intervention) and during ultrasound assessment 2 (which will occur 10 minutes after the training intervention). Each assessment will be 15 minutes in duration.
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Task completion time
Délai: Undertaken during ultrasound assessment 1 (before training intervention) and during ultrasound assessment 2 (which will occur 10 minutes after the training intervention was undertaken). Each assessment will be 15 minutes in duration.
|
Time taken to finish needling task
|
Undertaken during ultrasound assessment 1 (before training intervention) and during ultrasound assessment 2 (which will occur 10 minutes after the training intervention was undertaken). Each assessment will be 15 minutes in duration.
|
|
Change in Fixation durations
Délai: Undertaken during ultrasound assessment 1 (before training intervention) and during ultrasound assessment 2 (which will occur 10 minutes after the training intervention was undertaken). Each assessment will be 15 minutes in duration.
|
The total duration in seconds during the task that the participant spends engaging fixation visual behaviour in pre-defined areas of interest during the needling task
|
Undertaken during ultrasound assessment 1 (before training intervention) and during ultrasound assessment 2 (which will occur 10 minutes after the training intervention was undertaken). Each assessment will be 15 minutes in duration.
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: David W Hewson, MBBS, University of Nottingham
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 434-1912
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .