NCT02928796

Brief Summary

Uncovering the distinct measurements and features that potentially exist in different levels of expertise when performing cardiology-based procedures. There is a belief that tracking the visual attention and other psychophysiological measures during performance of these procedures may assist in uncovering the attentional capacity of participants and how it links with overall performance.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 10, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Last Updated

October 10, 2016

Status Verified

October 1, 2016

Enrollment Period

1.1 years

First QC Date

September 30, 2016

Last Update Submit

October 6, 2016

Conditions

Keywords

Attentional capacityWorking memorySimulation-based trainingEye-trackingVisual attentionPsychophysiological measurementSurgical simulationComputer-based simulation

Outcome Measures

Primary Outcomes (2)

  • Mean attentional capacity

    The hypothesis is that a significant statistical relationship will be found between measured attentional capacity (via a card reading task) and overall surgical task performance grading. Attentional capacity, we hypothesise, will be a statistically significant predictor for discriminating between performance level.

    Up to 12 Months.

  • Visual attention characteristics for stimulus reading 'card' task

    The hypothesis is that a significant statistical relationship will be found with characteristics of participant's visual attention (e.g. mean fixation duration, mean saccade latency, overall visual latency before card acknowledgement) and the measured attentional capacity.

    Up to 12 months.

Study Arms (2)

Trainees

Registrar Cardiologists

Behavioral: Cognitive Stimulus

Trainers

Consultant Cardiologists

Behavioral: Cognitive Stimulus

Interventions

Participants to pay attention to a supplementary display monitor and respond to specified stimulus images, all while performing the simulated cardiology-based procedure.

TraineesTrainers

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Qualified medical professionals, trainees/registrars or trainers/consultants, working within the cathlab environment and discipline of interventional cardiology.

You may qualify if:

  • They must be qualified medical doctor with specific interest in cardiology (e.g. consultant cardiologist). Consultant group must contain consultants only and registrar group must have enrolled registrars only.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASSERT Centre, University College Cork

Cork, Cork, Ireland

RECRUITING

Related Publications (1)

  • Currie J, Bond RR, McCullagh P, Black P, Finlay DD, Gallagher S, Kearney P, Peace A, Stoyanov D, Bicknell CD, Leslie S, Gallagher AG. Wearable technology-based metrics for predicting operator performance during cardiac catheterisation. Int J Comput Assist Radiol Surg. 2019 Apr;14(4):645-657. doi: 10.1007/s11548-019-01918-0. Epub 2019 Feb 7.

Study Officials

  • Anthony G. Gallagher, DSc, PhD

    University College Cork

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Currie, BSc

CONTACT

Anthony G. Gallagher, DSc, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research, Professor of Technology Enhanced Learning

Study Record Dates

First Submitted

September 30, 2016

First Posted

October 10, 2016

Study Start

September 1, 2016

Primary Completion

October 1, 2017

Last Updated

October 10, 2016

Record last verified: 2016-10

Locations