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

NCT04913688 | Unknown

• 1 other identifier: 2021-01-128
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

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.

suspected DVT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

who visiting an emergency department of tertiary hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hee Yoon, Professor

  Samsung medical center, Emergency department

  STUDY CHAIR

Central Study Contacts

Hee Yoon, Professor

CONTACT

+821099335581; wildhi.yoon@samsung.com

Sooyeon Kang, fellow

CONTACT

+821031574718; syrei3.kang@samsung.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2021
• First Posted: June 4, 2021
• Study Start: May 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: February 28, 2022
• Last Updated: June 4, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)