The Learning Curve of Emergency Physicians Performed Lowe... | NCT04913688

Studies
The Learning Curve of Emergency Physicians Performed Lower-extremity Ultrasonography in the Diagnosis of DVT

NCT04913688

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Jun 4, 2021Actual

Enrollment

88Estimated

Phase

Not provided

Conditions

Deep Vein Thrombosis

Interventions

bedside ultrasound performed group

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2021Actual

Primary Completion Date

Jan 31, 2022Estimated

Completion Date

Feb 28, 2022Estimated

First Submitted Date

May 30, 2021

First Submission Date that Met QC Criteria

May 30, 2021

First Posted Date

Jun 4, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2021

Last Update Posted Date

Jun 4, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

88Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
suspected DVT group		If deep vein thrombosis (DVT) is suspected among patients who visit the emergency department, the patients become eligible for study subjects.	Procedure: bedside ultrasound performed group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bedside ultrasound performed group	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

who visiting an emergency department of tertiary hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hee Yoon, Professor	Contact	+821099335581		wildhi.yoon@samsung.com
Sooyeon Kang, fellow	Contact	+821031574718		syrei3.kang@samsung.com

Overall Officials

Name	Affiliation	Role
Hee Yoon, Professor	Samsung medical center, Emergency department	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center	Recruiting	Seoul		06351	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020246	Venous Thrombosis

Ancestor Terms

ID	Term
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided