EmergenciesNCT04834700
Comparison of Hands-on Versus Online Learning About Ocular Ultrasound
A study testing online group in people with Emergencies, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
In patients who visit an emergency room with ocular symptoms, point-of-care ultrasound can quickly identify several emergency diseases. While training of eye ultrasound skills is useful for emergency physicians, hands-on education is risky in pandemic situation such as coronavirus disease 19 (COVID19). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergencies
- What is being tested?
- online group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Dec 2020to Oct 2021
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Those who have received basic ultrasound education but have not received ocular ultrasound education
- Residents and interns working in the emergency room
- Those who voluntarily agree to participate in the research through the recruitment announcement
- Adults over 18 years of age without eye-related symptoms
- Those who do not have unusual findings in the eye when scanning by ultrasound
- Those who voluntarily agree to participate in the research through the recruitment announcement
Who cannot join
- Those with a history of ophthalmic diseases
- Those who have a history of ophthalmic surgery such as lens implantation
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Hee Yoon, PhD., MD., 81-02-3410-2053, wildhi.yoon@samsung.com
About this study
Official title: Comparison of Hands-on Versus Online Learning in Teaching Ultrasound Skills for Eye
In patients who visit an emergency room with ocular symptoms, point-of-care ultrasound can quickly identify several emergency diseases. While training of eye ultrasound skills is useful for emergency physicians, hands-on education is risky in pandemic situation such as coronavirus disease 19 (COVID19). As a solution to this, non-face-to-face education via online has been on the rise. The investigators hypothesized that even an online education is enough to perform basic eye ultrasound by emergency physician.
Read the detailed description
Since the eye is an superficial organ, it has excellent access to ultrasound. Also, the eye has a liquid-filled structure (vitreous body), it is suitable for obtaining some important findings with bedside ultrasound. In patients who visit an emergency room with ocular symptoms, point-of-care ultrasound can quickly identify several emergency diseases. While training of eye ultrasound skills is useful for emergency physicians, hands-on education is risky in pandemic situation such as COVID19. As a solution to this, non-face-to-face education via online has been on the rise. The investigators hypothesized that even an online education is enough to perform basic eye ultrasound by emergency physician.
- Conditions
- Emergencies
- Being tested
- online group
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online groupOther
In terms of teaching ultrasound, video lectures will be conducted rather than hands-on, which is the traditional method.
| Study group | Role | What they receive |
|---|---|---|
| hands-on group | No intervention | The doctors who participated in the study will be educated ocular ultrasound scanning method by hands-on about 20 minutes, and perform ocular ultrasound scans on two standard patients. |
| online group | Other | The doctors who participated in the study will be educated ocular ultrasound scanning method by online lecture about 20 minutes, and perform ocular ultrasound scans on two standard patients. Receives: Other: online group |
What is being measured
The primary outcome is the main question the study is designed to answer.
scan score
We make our own guideline to evaluate ocular ultrasound scans. The ocular ultrasound images performed participants are evaluated according to the guideline.
We compare the scores of the hands-on group and the online group to see if there is a significant difference between the two groups.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Optic nerve sheath diameter (ONSD)
Two ultrasound experts measure the standard patient's ONSD and use it as a reference value.
The course of ocular ultrasound scanning involves measuring ONSD. We compare the measured ONSD of the hands-on group and the online group to see if there is a significant difference between the two groups.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start17 Dec 2020
- Primary completion1 Apr 2021
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hee Yoon, MD., PhD., Study director, Samsung medical center, Emergency department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834700
- Sponsor's protocol ID
- 2020-09-174
- Status last verified
- Mar 2021
- First submitted
- 5 Apr 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hands-on Versus Online Learning in Teaching Ultrasound Skills for Eye
- ClinicalTrials.gov ID
- NCT04834700
- Acronym / sponsor ID
- 2020-09-174
- Conditions
- Emergencies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- Oct 2021 (estimated)
- First posted
- 8 Apr 2021 (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.
In patients who visit an emergency room with ocular symptoms, point-of-care ultrasound can quickly identify several emergency diseases. While training of eye ultrasound skills is useful for emergency physicians, hands-on education is risky in pandemic situation such as coronavirus disease 19 (COVID19). As a solution to this, non-face-to-face education via online has been on the rise. The investigators hypothesized that even an online education is enough to perform basic eye ultrasound by emergency physician.
Detailed description
Since the eye is an superficial organ, it has excellent access to ultrasound. Also, the eye has a liquid-filled structure (vitreous body), it is suitable for obtaining some important findings with bedside ultrasound. In patients who visit an emergency room with ocular symptoms, point-of-care ultrasound can quickly identify several emergency diseases. While training of eye ultrasound skills is useful for emergency physicians, hands-on education is risky in pandemic situation such as COVID19. As a solution to this, non-face-to-face education via online has been on the rise. The investigators hypothesized that even an online education is enough to perform basic eye ultrasound by emergency physician.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hands-on group | No intervention | –The doctors who participated in the study will be educated ocular ultrasound scanning method by hands-on about 20 minutes, and perform ocular ultrasound scans on two standard patients. |
| online group | Other | Other: online groupThe doctors who participated in the study will be educated ocular ultrasound scanning method by online lecture about 20 minutes, and perform ocular ultrasound scans on two standard patients. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Those who have received basic ultrasound education but have not received ocular ultrasound education
- Residents and interns working in the emergency room
- Those who voluntarily agree to participate in the research through the recruitment announcement
- Adults over 18 years of age without eye-related symptoms
- Those who do not have unusual findings in the eye when scanning by ultrasound
Key exclusion criteria (2 listed)
- Those with a history of ophthalmic diseases
- Those who have a history of ophthalmic surgery such as lens implantation
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 |
|---|---|---|
| online groupIn terms of teaching ultrasound, video lectures will be conducted rather than hands-on, which is the traditional method. | Other | online group |
Primary outcome
scan score
Time frame: through study completion, an average of 1 year
We make our own guideline to evaluate ocular ultrasound scans. The ocular ultrasound images performed participants are evaluated according to the guideline. We compare the scores of the hands-on group and the online group to see if there is a significant difference between the two groups.
1 secondary outcome
Optic nerve sheath diameter (ONSD)
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Hee Yoon, MD., PhD. study director
Samsung medical center, Emergency department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing online group in people with Emergencies, run by Samsung Medical Center at 1 site in South Korea.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Jun 2021. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hee Yoon, MD., PhD. (+821099335581, wildhi.yoon@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scan score (time frame: through study completion, an average of 1 year). 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 2 Jun 2021.