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

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.

Study Overview

• Status: Recruiting
• Conditions: Deep Vein Thrombosis
• Intervention / Treatment: Procedure: bedside ultrasound performed group

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 Type: Observational
• Enrollment (Anticipated): 88

Contacts and Locations

• Study Contact: Name: Hee Yoon, Professor; Phone Number: +821099335581; Email: wildhi.yoon@samsung.com
• Study Contact Backup: Name: Sooyeon Kang, fellow; Phone Number: +821031574718; Email: syrei3.kang@samsung.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center
    • Contact: Hee Yoon, PhD., MD.; Phone Number: 81-02-3410-2053; Email: wildhi.yoon@samsung.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

who visiting an emergency department of tertiary hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Study Chair: Hee Yoon, Professor, Samsung medical center, Emergency department

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): January 31, 2022
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: May 30, 2021
• First Submitted That Met QC Criteria: May 30, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: May 30, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Embolism and Thrombosis; Emergencies; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: 2021-01-128

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No