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

Sponsor
Samsung Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04913688
Collaborator
(none)
88
1
10
8.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
88 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
The Learning Curve of Emergency Physicians Performed Point-of-care Lower-extremity Ultrasonography in the Diagnosis of Deep Venous Thrombosis
Actual Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Jan 31, 2022
Anticipated Study Completion Date :
Feb 28, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. The number of ultrasound exams [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsung Medical Center Seoul Korea, Republic of 06351

Sponsors and Collaborators

  • Samsung Medical Center

Investigators

  • Study Chair: Hee Yoon, Professor, Samsung medical center, Emergency department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT04913688
Other Study ID Numbers:
  • 2021-01-128
First Posted:
Jun 4, 2021
Last Update Posted:
Jun 4, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 4, 2021