UltrasoundNCT06775899
Equivalence Study Comparing a Cost-Effective PC-Based Ultrasound Training Tool to Traditional Simulators in Third-Year Medical Students
A study testing PC-Based Ultrasound Training Tool and Traditional Ultrasound Simulator (VausSim) in people with Ultrasound and Medical Training, run by University of Turin, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ultrasound, Medical Training, Simulation Based Learning
- What is being tested?
- PC-Based Ultrasound Training Tool and Traditional Ultrasound Simulator (VausSim)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteItaly
- Study dates
- 4 Mar 2024to 26 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
SimTo Advanced Medical Simulation Centre
Turin, Italy, Piedmont, 10124
About this study
Official title: Evaluating the Efficacy of a Cost-Effective PC-Based Tool as a Non-Inferior Alternative to Traditional Ultrasound Simulators in Medical Education
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:
Read more
- Does the PC-based tool help participants improve their ability to optimize ultrasound images in a way comparable to the traditional simulator?
- Can participants using the PC-based tool identify and interpret pathological conditions with the same accuracy as those using the traditional simulator?
Participants are third-year medical students enrolled in a structured internship. They will:
- Watch educational videos covering key concepts in thoracic and abdominal ultrasound imaging.
- Rotate through training stations where they will practice using either the PC-based tool or the traditional simulator.
- Perform hands-on exercises with healthy volunteers to practice image acquisition and recognition of anatomical structures.
- Complete pre- and post-training assessments to measure their progress in skills such as image optimization and identifying pathological conditions.
This study aims to explore whether a low-cost digital solution can provide equal educational value, offering a practical alternative to traditional simulators in resource-limited settings.
- Being tested
- PC-Based Ultrasound Training Tool, Traditional Ultrasound Simulator (VausSim)
- Keywords
- Medical Education, Ultrasound Simulation, PC-Based Training Tool, Thoracic Ultrasound, Abdominal Ultrasound, Cost-effective Simulator, Clinical Skills Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC-Based Ultrasound Training ToolDevice
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.
Traditional Ultrasound Simulator (VausSim)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: PC-Based Ultrasound Training Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Image Optimization Skills
Change in the Objective Structured Assessment of Ultrasound Skills (OSAUS) scores for image optimization pre- and post-training.
Measured: 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: Measured immediately before and after the training session.
Secondary outcomes (2)
Participant Satisfaction with Training
Participant satisfaction assessed through a Likert-scale questionnaire (1-5, where 5 = very satisfied).
Measured: Measured immediately after the training session.
Time Required for Image Acquisition
Change in the time taken to acquire specific ultrasound views in healthy volunteers and pathology recognition (measured in seconds).
Measured: Measured immediately before and after the training session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start4 Mar 2024
- Primary completion25 Apr 2024
- Study completion26 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Agostino, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775899
- Sponsor's protocol ID
- 219864
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 27622424Weimer 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.
PubMed 38721350Pezel 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.
PubMed 37070491Damewood 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.
PubMed 21496145
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of a Cost-Effective PC-Based Tool as a Non-Inferior Alternative to Traditional Ultrasound Simulators in Medical Education
- ClinicalTrials.gov ID
- NCT06775899
- Acronym / sponsor ID
- 219864
- Keywords
- Medical Education, Ultrasound Simulation, PC-Based Training Tool, Thoracic Ultrasound, Abdominal Ultrasound, Cost-effective Simulator, Clinical Skills Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 26 Apr 2024 (actual)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the PC-based tool help participants improve their ability to optimize ultrasound images in a way comparable to the traditional simulator?
- Can participants using the PC-based tool identify and interpret pathological conditions with the same accuracy as those using the traditional simulator?
Participants are third-year medical students enrolled in a structured internship. They will:
- Watch educational videos covering key concepts in thoracic and abdominal ultrasound imaging.
- Rotate through training stations where they will practice using either the PC-based tool or the traditional simulator.
- Perform hands-on exercises with healthy volunteers to practice image acquisition and recognition of anatomical structures.
- Complete pre- and post-training assessments to measure their progress in skills such as image optimization and identifying pathological conditions.
This study aims to explore whether a low-cost digital solution can provide equal educational value, offering a practical alternative to traditional simulators in resource-limited settings.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulator Thoracic and Abdominal | Active comparator | Device: Traditional Ultrasound Simulator (VausSim)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. |
| PC-based tool | Experimental | Device: PC-Based Ultrasound Training ToolParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PC-Based Ultrasound Training ToolAn 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. | Device | PC-based tool |
| Traditional Ultrasound Simulator (VausSim)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. | Device | Simulator Thoracic and Abdominal |
Primary outcome
Improvement in Image Optimization Skills
Time frame: Measured immediately before and after the training session.
Change in the Objective Structured Assessment of Ultrasound Skills (OSAUS) scores for image optimization pre- and post-training.
Pathology Recognition Accuracy
Time frame: Measured immediately before and after the training session.
Change in the ability to identify and interpret pathological ultrasound images, scored on a scale of 0-3 (0 = no recognition, 3 = full recognition).
2 secondary outcomes
Participant Satisfaction with Training
Time frame: Measured immediately after the training session.
Time Required for Image Acquisition
Time frame: Measured immediately before and after the training session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Background: PubMed 27622424Kollmann 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.
- Background: PubMed 38721350Weimer 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.
- Background: PubMed 37070491Pezel 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.
- Background: PubMed 21496145Damewood 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.
- Official page of the Advanced Medical Simulation Center at the University of Turin, providing resources and information about simulation-based medical educationLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PC-Based Ultrasound Training Tool and Traditional Ultrasound Simulator (VausSim) in people with Ultrasound and Medical Training, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Image Optimization Skills (time frame: Measured immediately before and after the training session.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06775899, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.