Ultrasound TrainingNCT07127588
Ultrasound Simulation or Traditional Ultrasound Training for General Practitioners?
A study testing Simulation based clinical ultrasound education and Traditional ultrasound education in people with Ultrasound Training, run by Aalborg University at 1 site in Denmark.
Trial summary
The goal of this study is to compare two different educational methods for training general practitioners (GPs) in point-of-care ultrasound. The main question it aims to answer is: Does the use of ultrasound phantoms and simulators result in superior post-course ultrasound skills compared to traditional training… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ultrasound Training
- What is being tested?
- Simulation based clinical ultrasound education and Traditional ultrasound education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Jun 2025to 4 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- The participant must be a postgraduate medical doctor specialized in general medicine/family medicine (general practitioner).
- The participant must have access to an ultrasound device during the study period.
Who cannot join
- General practitioners who have already participated in a basic point-of-care ultrasound education for general practitioners.
- General practitioners with potential conflicts of interest.
- Individuals with no signed informed consent to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Continuing Education of General Practitioners in Clinical Ultrasound - Ultrasound Simulation or Traditional Ultrasound Training?
The goal of this study is to compare two different educational methods for training general practitioners (GPs) in point-of-care ultrasound. The main question it aims to answer is:
- Does the use of ultrasound phantoms and simulators result in superior post-course ultrasound skills compared to traditional training methods involving healthy volunteers? Researchers will compare a group trained with traditional methods (scanning healthy volunteers) to a group trained using ultrasound phantoms and simulators to see if the different training methods result in different levels of ultrasound proficiency.
Read more
Participants will:
- Be 24 general practitioners randomized into two groups of 12.
- Receive training in five clinical ultrasound examinations: 1) Aortic abdominal aneurism, 2) gallstones, 3) pleural effusion, 4) hydronephrosis, and 5) free fluid in the abdomen (FAST scan).
- Begin with e-learning, followed by two in-person teaching seminars.
- Train at their clinics between course days: first on healthy volunteers, then on indicated patients.
- Upload scans to an online learning platform and receive feedback from instructors.
- Be assessed after 90 days using the validated Objective Structured Assessment of Ultrasound Skills (OSAUS) tool, with blinded evaluators.
- Conditions
- Ultrasound Training
- Being tested
- Simulation based clinical ultrasound education, Traditional ultrasound education
- Keywords
- Point-of-care ultrasound, Clinical ultrasound, Education, General practitioners, Simulation, Randomised controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation based clinical ultrasound educationOther
At the two hands-on teaching seminars, GPs in the intervention arm will receive training in five different clinical ultrasound examinations using an ultrasound phantom and an ultrasound simulator (Simbionix U/S Mentor). At the start of the first course day (8 hours), three basic modules will be conducted on the simulator, aimed at training hand-eye coordination and developing fundamental skills in probe movement, enhancing three-dimensional perception, and learning to use the various settings on the ultrasound simulator to achieve optimal imaging. At the first course day, the five clinical ultrasound examinations will be trained through a total of 13 simulation cases. On the second course day (4 hours), the participants will repeat the 13 simulation cases.
Traditional ultrasound educationOther
At the two hands-on teaching seminars, GPs in the control arm will receive training in five different clinical ultrasound examinations as according to an established and validated training program. At the start of the first course day (8 hours), the five clinical ultrasound examinations will be trained using healthy volunteers and still pictures for visualizing pathology. On the second course day (4 hours), the participants will train by repeating the five clinical ultrasound examinations on healthy volunteers.
| Study group | Role | What they receive |
|---|---|---|
| Simulation | Experimental | General practitioners allocated to the intervention arm will participate in the POCUS course with hands-on training on an ultrasound simulator which can portrait both the normal reference and pathology at hands-on teaching seminars. Receives: Other: Simulation based clinical ultrasound education |
| Healthy volunteers | Active comparator | General practitioners allocated to the control arm will participate in the POCUS course with hands-on training on healthy volunteers and pathology presented as still pictures and videos at hands-on teaching seminars. Receives: Other: Traditional ultrasound education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean OSAUS sum score across all five POCUS applications (min-max: 7-35)
Scanning competence is assessed similarly in the two groups by ultrasound expert reviewers blinded to participant allocation. The reviewers will use the OSAUS score, which consists of 7 items. Each item is rated using a Likert Scale with five points (1-5) giving a minimum score of 7 and maximum of 35 for each POCUS application.
Measured: At the third teaching seminar (day 90)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start26 Jun 2025
- Primary completion4 Dec 2025 (estimated)
- Study completion4 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound TrainingStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Nordsim
- Responsible party
- Principal investigator, Julie Jepsen Strøm, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127588
- Sponsor's protocol ID
- 262-1
- Status last verified
- Aug 2025
- First submitted
- 27 Jul 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuing Education of General Practitioners in Clinical Ultrasound - Ultrasound Simulation or Traditional Ultrasound Training?
- ClinicalTrials.gov ID
- NCT07127588
- Acronym / sponsor ID
- 262-1
- Conditions
- Ultrasound Training
- Keywords
- Point-of-care ultrasound, Clinical ultrasound, Education, General practitioners, Simulation, Randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Nordsim
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- 4 Dec 2025 (estimated)
- Study completion
- 4 Dec 2025 (estimated)
- First posted
- 17 Aug 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.
The goal of this study is to compare two different educational methods for training general practitioners (GPs) in point-of-care ultrasound. The main question it aims to answer is:
- Does the use of ultrasound phantoms and simulators result in superior post-course ultrasound skills compared to traditional training methods involving healthy volunteers? Researchers will compare a group trained with traditional methods (scanning healthy volunteers) to a group trained using ultrasound phantoms and simulators to see if the different training methods result in different levels of ultrasound proficiency.
Participants will:
- Be 24 general practitioners randomized into two groups of 12.
- Receive training in five clinical ultrasound examinations: 1) Aortic abdominal aneurism, 2) gallstones, 3) pleural effusion, 4) hydronephrosis, and 5) free fluid in the abdomen (FAST scan).
- Begin with e-learning, followed by two in-person teaching seminars.
- Train at their clinics between course days: first on healthy volunteers, then on indicated patients.
- Upload scans to an online learning platform and receive feedback from instructors.
- Be assessed after 90 days using the validated Objective Structured Assessment of Ultrasound Skills (OSAUS) tool, with blinded evaluators.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulation | Experimental | Other: Simulation based clinical ultrasound educationGeneral practitioners allocated to the intervention arm will participate in the POCUS course with hands-on training on an ultrasound simulator which can portrait both the normal reference and pathology at hands-on teaching seminars. |
| Healthy volunteers | Active comparator | Other: Traditional ultrasound educationGeneral practitioners allocated to the control arm will participate in the POCUS course with hands-on training on healthy volunteers and pathology presented as still pictures and videos at hands-on teaching seminars. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- The participant must be a postgraduate medical doctor specialized in general medicine/family medicine (general practitioner).
- The participant must have access to an ultrasound device during the study period.
Key exclusion criteria (3 listed)
- General practitioners who have already participated in a basic point-of-care ultrasound education for general practitioners.
- General practitioners with potential conflicts of interest.
- Individuals with no signed informed consent to participate.
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 |
|---|---|---|
| Simulation based clinical ultrasound educationAt the two hands-on teaching seminars, GPs in the intervention arm will receive training in five different clinical ultrasound examinations using an ultrasound phantom and an ultrasound simulator (Simbionix U/S Mentor). At the start of the first course day (8 hours), three basic modules will be conducted on the simulator, aimed at training hand-eye coordination and developing fundamental skills in probe movement, enhancing three-dimensional perception, and learning to use the various settings on the ultrasound simulator to achieve optimal imaging. At the first course day, the five clinical ultrasound examinations will be trained through a total of 13 simulation cases. On the second course day (4 hours), the participants will repeat the 13 simulation cases. | Other | Simulation |
| Traditional ultrasound educationAt the two hands-on teaching seminars, GPs in the control arm will receive training in five different clinical ultrasound examinations as according to an established and validated training program. At the start of the first course day (8 hours), the five clinical ultrasound examinations will be trained using healthy volunteers and still pictures for visualizing pathology. On the second course day (4 hours), the participants will train by repeating the five clinical ultrasound examinations on healthy volunteers. | Other | Healthy volunteers |
Primary outcome
Mean OSAUS sum score across all five POCUS applications (min-max: 7-35)
Time frame: At the third teaching seminar (day 90)
Scanning competence is assessed similarly in the two groups by ultrasound expert reviewers blinded to participant allocation. The reviewers will use the OSAUS score, which consists of 7 items. Each item is rated using a Likert Scale with five points (1-5) giving a minimum score of 7 and maximum of 35 for each POCUS application.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation based clinical ultrasound education and Traditional ultrasound education in people with Ultrasound Training, run by Aalborg University at 1 site in Denmark.
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 2 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: looking for participants now, as of the sponsor's last update on 17 Aug 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie J Strøm (004520869389, jrjepsen@dcm.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean OSAUS sum score across all five POCUS applications (min-max: 7-35) (time frame: At the third teaching seminar (day 90)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.