Deep Vein ThrombosisNCT04913688
The Learning Curve of Emergency Physicians Performed Lower-extremity Ultrasonography in the Diagnosis of DVT
An observational study of Deep Vein Thrombosis, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
If deep vein thrombosis (DVT) is suspected among patients who have symptoms such as pain or swelling of the lower extremities, duplex ultrasound of the lower limb is the first-line imaging modality to diagnose DVT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis
- What is being tested?
- bedside ultrasound performed group
- Type of treatment
- Surgery or procedure
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2021to 28 Feb 2022
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: who visiting an emergency department of tertiary hospital
Who may be able to join
- Patients 18 years of age or older
- Among patients who visited the emergency department with symptoms related to lower extremities (e.g. lower extremity pain, swelling of the lower extremities, numbness of the lower extremities, redness of the lower extremities), the clinician judges that an ultrasonography of the lower extremity is necessary based on the medical history, physical examination, and blood test results.
- (or) Patients who need additional ultrasound of the lower extremity vein to check for deep vein thrombosis due to the detection of a pulmonary thromboembolism in an emergency department
Who cannot join
- Do not agree to participate in the study
- Patients who refuse ultrasound of the lower extremities by an emergency physician or radiologist
- Patients who have already performed an ultrasound of the lower extremities at another hospital and have been diagnosed with DVT
- Patients with a history of chronic deep vein thrombosis
- Patients with hemodynamic instability to refer to diagnostic imaging facility for duplex exam
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: The Learning Curve of Emergency Physicians Performed Point-of-care Lower-extremity Ultrasonography in the Diagnosis of Deep Venous Thrombosis
If deep vein thrombosis (DVT) is suspected among patients who have symptoms such as pain or swelling of the lower extremities, duplex ultrasound of the lower limb is the first-line imaging modality to diagnose DVT. However, duplex ultrasound is time consuming, requires patient transport to a diagnostic imaging facility.
In recent years, abbereviated bedside ultrasound technique has been accepted by emergency physician to diagnose the presence of DVT. Several studies have proven that the accuracy of this abbreviated bedsude ultrasound for assessing the presence of deep vein thrombosis is not inferior to experts, but how much ultrasound experience is required to obtain the accuracy that does not inferior to experts has yet to be studied.
The aim of this study is to identify how much learning by emergency physicians is needed to obtain the accuracy of the lower extremity ultrasound examination comparable to that of experts.
Read the detailed description
If deep vein thrombosis (DVT) is suspected among patients who have symptoms such as pain or swelling of the lower extremities, duplex ultrasound of the lower limb is the first-line imaging modality to diagnose DVT. However, duplex ultrasound is time consuming, requires patient transport to a diagnostic imaging facility, and the immediate availability of a trained radiologist or other vascular physician to provide a result since most physicians are unable to interpret such imaging.
In recent years, abbereviated bedside ultrasound technique has been accepted by emergency physician to diagnose the presence of DVT. Compression is applied to assess the presence of thrombus and collapsibility only in three regions - iliofemoral junction, superficial femoral vein, popliteal vein.
Several studies have proven that the accuracy of this abbreviated bedsude ultrasound for assessing the presence of deep vein thrombosis is not inferior to experts, but how much ultrasound experience is required to obtain the accuracy that does not inferior to experts has yet to be studied.
The aim of this study is to identify how much learning by emergency physicians is needed to obtain the accuracy of the lower extremity ultrasound examination comparable to that of experts.
- Conditions
- Deep Vein Thrombosis
- Being tested
- bedside ultrasound performed group
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bedside ultrasound performed groupProcedure or surgery
If deep vein thrombosis (DVT) is suspected among patients who visit the emergency department, an emergency physician performs bedside ultrasound of lower extremities to the patients agreed to participate in this study. The patients also are examined duplex ultrasound by radiologist.
| Study group | Role | What they receive |
|---|---|---|
| suspected DVT group | If deep vein thrombosis (DVT) is suspected among patients who visit the emergency department, the patients become eligible for study subjects. Receives: Procedure: bedside ultrasound performed group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of ultrasound exams
The number of ultrasound exams required until the bedside ultrasound of the lower extremities performed by an emergency physician has adequate proficiency.
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 posted4 Jun 2021
- Study start1 May 2021
- Primary completion31 Jan 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hee Yoon, Professor, Study chair, Samsung medical center, Emergency department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913688
- Sponsor's protocol ID
- 2021-01-128
- Status last verified
- May 2021
- First submitted
- 30 May 2021
- Last updated
- 4 Jun 2021
- Results posted
- 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 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Learning Curve of Emergency Physicians Performed Point-of-care Lower-extremity Ultrasonography in the Diagnosis of Deep Venous Thrombosis
- ClinicalTrials.gov ID
- NCT04913688
- Acronym / sponsor ID
- 2021-01-128
- Conditions
- Deep Vein Thrombosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 4 Jun 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.
If deep vein thrombosis (DVT) is suspected among patients who have symptoms such as pain or swelling of the lower extremities, duplex ultrasound of the lower limb is the first-line imaging modality to diagnose DVT. However, duplex ultrasound is time consuming, requires patient transport to a diagnostic imaging facility.
In recent years, abbereviated bedside ultrasound technique has been accepted by emergency physician to diagnose the presence of DVT. Several studies have proven that the accuracy of this abbreviated bedsude ultrasound for assessing the presence of deep vein thrombosis is not inferior to experts, but how much ultrasound experience is required to obtain the accuracy that does not inferior to experts has yet to be studied.
The aim of this study is to identify how much learning by emergency physicians is needed to obtain the accuracy of the lower extremity ultrasound examination comparable to that of experts.
Detailed description
If deep vein thrombosis (DVT) is suspected among patients who have symptoms such as pain or swelling of the lower extremities, duplex ultrasound of the lower limb is the first-line imaging modality to diagnose DVT. However, duplex ultrasound is time consuming, requires patient transport to a diagnostic imaging facility, and the immediate availability of a trained radiologist or other vascular physician to provide a result since most physicians are unable to interpret such imaging.
In recent years, abbereviated bedside ultrasound technique has been accepted by emergency physician to diagnose the presence of DVT. Compression is applied to assess the presence of thrombus and collapsibility only in three regions - iliofemoral junction, superficial femoral vein, popliteal vein.
Several studies have proven that the accuracy of this abbreviated bedsude ultrasound for assessing the presence of deep vein thrombosis is not inferior to experts, but how much ultrasound experience is required to obtain the accuracy that does not inferior to experts has yet to be studied.
The aim of this study is to identify how much learning by emergency physicians is needed to obtain the accuracy of the lower extremity ultrasound examination comparable to that of experts.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| suspected DVT group | – | Procedure: bedside ultrasound performed groupIf deep vein thrombosis (DVT) is suspected among patients who visit the emergency department, the patients become eligible for study subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- who visiting an emergency department of tertiary hospital
Key inclusion criteria (3 listed)
- Patients 18 years of age or older
- Among patients who visited the emergency department with symptoms related to lower extremities (e.g. lower extremity pain, swelling of the lower extremities, numbness of the lower extremities, redness of the lower extremities), the clinician judges that an ultrasonography of the lower extremity is necessary based on the medical history, physical examination, and blood test results.
- (or) Patients who need additional ultrasound of the lower extremity vein to check for deep vein thrombosis due to the detection of a pulmonary thromboembolism in an emergency department
Key exclusion criteria (5 listed)
- Do not agree to participate in the study
- Patients who refuse ultrasound of the lower extremities by an emergency physician or radiologist
- Patients who have already performed an ultrasound of the lower extremities at another hospital and have been diagnosed with DVT
- Patients with a history of chronic deep vein thrombosis
- Patients with hemodynamic instability to refer to diagnostic imaging facility for duplex exam
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 |
|---|---|---|
| bedside ultrasound performed groupIf deep vein thrombosis (DVT) is suspected among patients who visit the emergency department, an emergency physician performs bedside ultrasound of lower extremities to the patients agreed to participate in this study. The patients also are examined duplex ultrasound by radiologist. | Procedure or surgery | suspected DVT group |
Primary outcome
The number of ultrasound exams
Time frame: through study completion, an average of 1 year
The number of ultrasound exams required until the bedside ultrasound of the lower extremities performed by an emergency physician has adequate proficiency.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 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, Professor study chair
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?
An observational study of Deep Vein Thrombosis, 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 3 inclusion and 5 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 4 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, Professor (+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?
The number of ultrasound exams (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 4 Jun 2021.