NCT06775899

Brief Summary

Brief Summary: The goal of this clinical trial is to determine if a cost-effective, PC-based ultrasound training tool is as effective as a traditional, medium-cost ultrasound simulator for teaching third-year medical students thoracic and abdominal ultrasound skills. This study focuses on improving access to high-quality ultrasound training in educational settings with limited resources. The main questions it aims to answer are:

  1. 1.Does the PC-based tool help participants improve their ability to optimize ultrasound images in a way comparable to the traditional simulator?
  2. 2.Can participants using the PC-based tool identify and interpret pathological conditions with the same accuracy as those using the traditional simulator?
  3. 3.Watch educational videos covering key concepts in thoracic and abdominal ultrasound imaging.
  4. 4.Rotate through training stations where they will practice using either the PC-based tool or the traditional simulator.
  5. 5.Perform hands-on exercises with healthy volunteers to practice image acquisition and recognition of anatomical structures.
  6. 6.Complete pre- and post-training assessments to measure their progress in skills such as image optimization and identifying pathological conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
408

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 4, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 15, 2025

Completed
Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

January 9, 2025

Last Update Submit

January 14, 2025

Conditions

Keywords

Medical EducationUltrasound SimulationPC-Based Training ToolThoracic UltrasoundAbdominal UltrasoundCost-effective SimulatorClinical Skills Development

Outcome Measures

Primary Outcomes (2)

  • Improvement in Image Optimization Skills

    Change in the Objective Structured Assessment of Ultrasound Skills (OSAUS) scores for image optimization pre- and post-training.

    Measured immediately before and after the training session.

  • Pathology Recognition Accuracy

    Change in the ability to identify and interpret pathological ultrasound images, scored on a scale of 0-3 (0 = no recognition, 3 = full recognition).

    Measured immediately before and after the training session.

Secondary Outcomes (2)

  • Participant Satisfaction with Training

    Measured immediately after the training session.

  • Time Required for Image Acquisition

    Measured immediately before and after the training session.

Study Arms (2)

Simulator Thoracic and Abdominal

ACTIVE COMPARATOR

Participants in this group will receive ultrasound training using a traditional, medium-cost ultrasound simulator (VausSim). This simulator allows students to practice image acquisition and pathology recognition in a controlled environment. Training will also include hands-on practice with healthy volunteers. The performance of students in this group will be compared to those using the PC-based tool to determine if both methods produce similar learning outcomes.

Device: Traditional Ultrasound Simulator (VausSim)

PC-based tool

EXPERIMENTAL

Participants in this group will receive ultrasound training using an interactive PC-based tool. This tool provides real ultrasound images and videos to simulate pathology recognition and image optimization. Students will rotate through different training stations, including hands-on practice with healthy volunteers. The goal is to assess whether this low-cost digital tool is as effective as a traditional ultrasound simulator for teaching ultrasound skills.

Device: PC-Based Ultrasound Training Tool

Interventions

An interactive, PowerPoint-based PC tool designed to simulate pathology recognition and ultrasound image optimization for medical students. It provides real ultrasound videos and images, allowing students to practice diagnostic interpretation and image acquisition in a structured training format.

PC-based tool

A medium-cost ultrasound simulator used for hands-on training in thoracic and abdominal ultrasound. It allows medical students to practice probe handling, image acquisition, and pathology recognition in a controlled simulation environment.

Simulator Thoracic and Abdominal

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Third-year medical students enrolled in the "Approach to Ultrasound" internship.
  • Participants who have completed the preliminary blended learning videos on thoracic and abdominal ultrasound techniques.
  • Participants with or without prior minimal experience in using an ultrasound probe, provided they have not undergone formal specialized ultrasound training.

You may not qualify if:

  • Inability to attend all training sessions and assessments as per the study schedule.
  • Physical or medical conditions that limit the ability to perform hands-on ultrasound practice (e.g., musculoskeletal injuries).
  • Refusal to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SimTo Advanced Medical Simulation Centre

Turin, Italy, Piedmont, 10124, Italy

Location

Related Publications (4)

  • Kollmann C, Flor M, Bader R. A web-based modern ultrasound diagnostic scanner simulation (SimulUS) for undergraduate medical e-learning education. Med Ultrason. 2016 Sep;18(3):408-9. doi: 10.11152/mu.2013.2066.183.kol. No abstract available.

    PMID: 27622424BACKGROUND
  • Weimer J, Recker F, Hasenburg A, Buggenhagen H, Karbach K, Beer L, Weimer A, Schiestl L, Lorenz L, Kloeckner R, Dionysopoulou A. Development and evaluation of a "simulator-based" ultrasound training program for university teaching in obstetrics and gynecology-the prospective GynSim study. Front Med (Lausanne). 2024 Apr 24;11:1371141. doi: 10.3389/fmed.2024.1371141. eCollection 2024.

    PMID: 38721350BACKGROUND
  • Pezel T, Dreyfus J, Mouhat B, Thebaut C, Audureau E, Bernard A, Badie YL, Bohbot Y, Fard D, Nguyen LS, Monteil C, Biere L, Le Ven F, Canu M, Ribeyrolles S, Mion B, Bazire B, Fauvel C, Cautela J, Cambet T, Le Tourneau T, Donal E, Lafitte S, Magne J, Mansencal N, Coisne A; SIMULATOR investigators. Effectiveness of Simulation-Based Training on Transesophageal Echocardiography Learning: The SIMULATOR Randomized Clinical Trial. JAMA Cardiol. 2023 Mar 1;8(3):248-256. doi: 10.1001/jamacardio.2022.5016.

    PMID: 37070491BACKGROUND
  • Damewood S, Jeanmonod D, Cadigan B. Comparison of a multimedia simulator to a human model for teaching FAST exam image interpretation and image acquisition. Acad Emerg Med. 2011 Apr;18(4):413-9. doi: 10.1111/j.1553-2712.2011.01037.x.

    PMID: 21496145BACKGROUND

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Research Technician

Study Record Dates

First Submitted

January 9, 2025

First Posted

January 15, 2025

Study Start

March 4, 2024

Primary Completion

April 25, 2024

Study Completion

April 26, 2024

Last Updated

January 16, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

The individual participant data (IPD) from this study will not be shared at this time because additional analyses and follow-up studies are currently in progress. Future research will further explore the implications of the findings, and data sharing may be reconsidered once all related studies are completed and published

Locations