NCT06355557

Brief Summary

The aim of the study is to investigate if hands-on training for basic CCE with virtual reality simulators or guided by artificial intelligence is non-inferior to training by an experienced instructor.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

April 4, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

9 months

First QC Date

April 4, 2024

Last Update Submit

April 8, 2024

Conditions

Keywords

artificial intelligence, echocardiography, POCUS

Outcome Measures

Primary Outcomes (1)

  • Improvement in image acquisition and structure identification at the end of 3 months.

    The images acquired during that timeframe will be scored using the validated Rapid Assessment of Competency in Echocardiography Scale. The experienced CCE trainer who will score the subject will be blinded to which arm of the study the subject is in

    3 months

Study Arms (3)

22 medical students (AI)

ACTIVE COMPARATOR

medical students randomised to this arm

Other: AI enabled ultrasound system for self-directed learning

22 medical students (Simulator)

ACTIVE COMPARATOR

medical students randomised to this arm

Other: Simulator for self-directed learning

22 medical students (control)

ACTIVE COMPARATOR

medical students randomised to this arm

Other: traditional with human instructors

Interventions

use of the AI enabled ultrasound system for self-directed learning

Also known as: AI-enabled ultrasound system (Kosmos(TM))
22 medical students (AI)

use of the simulator for self-directed learning

22 medical students (Simulator)

Medical students who are randomised to this arm

22 medical students (control)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medical students will have limited clinical exposure to critical care echocardiography
  • above the age of 21 years

You may not qualify if:

  • prior attendance of a critical care echocardiography courses or
  • refusal to participate in the study or complete both hands on sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tan Tock Seng Hospital

Singapore, 319581, Singapore

RECRUITING

Related Publications (1)

  • Lau YH, Acharyya S, Wee CWL, Xu H, Saclolo RP, Cao K, Fong WK. Effectiveness of traditional, artificial intelligence-assisted, and virtual reality training modalities for focused cardiac ultrasound skill acquisition: a randomised controlled study. Ultrasound J. 2025 Nov 21;17(1):61. doi: 10.1186/s13089-025-00469-7.

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 3-arm prospective randomised controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant

Study Record Dates

First Submitted

April 4, 2024

First Posted

April 9, 2024

Study Start

April 4, 2024

Primary Completion

December 31, 2024

Study Completion

January 1, 2025

Last Updated

April 9, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

local PDPA and data sharing rules

Locations