DVT Ultrasound in the Emergency Department

Deep Vein Thrombosis Clinical Trial

Official title:

An Observational Study of Emergency Medicine Resident Performed Ultrasonography for DVT.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02369263
• Other study ID #: EMP2013-01
• Status: Completed
• Phase: N/A
• First received: April 11, 2013
• Last updated: February 17, 2015
• Start date: May 2013
• Est. completion date: November 2014

Study information

• Verified date: February 2015
• Source: Emergency Medicine Physicians, Nevada
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Emergency Medicine (EM) Residents routinely conduct bedside ultrasound exams in the Emergency Department (ED) employing the two point compression method. This study endeavors to investigate the accuracy and utility of bedside ultrasound for Deep Vein Thrombosis (DVT) in the ED by EM Residents by comparing the results of that exam against the gold standard of a DVT ultrasound performed in the Radiology Department and interpreted by a Radiologist.

Description:

For subjects with suspicion of DVT to the Emergency Department, an EM Resident will perform a bedside non-diagnostic two point compression DVT Ultrasound. Subjects will then receive a diagnostic DVT Ultrasound in the Radiology Department with official radiologist interpretation. The bedside ultrasound will not interfere with or delay the diagnostic ultrasound. Patient demographic and clinical data will be collected for validation purposes. Validation of the The EM Resident interpretation will be accomplished by comparison to the official Radiologist interpretation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: November 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or older

• Suspect of having DVT

Exclusion Criteria:

• Known DVT

• DVT with in previous 6 months

• DVT Ultrasound within the last 6 months

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• DVT
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
United States	University Medical Center of Southern Nevada	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Emergency Medicine Physicians, Nevada

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome measures is the proportion of agreement between Resident performed two point DVT ultrasaound and the Radiologist interpertation of a formal DVT ultrasound.	Two point Emergency Medicine Resident preformed DVT Ultrasound (5 minute procedure) results will be compared as a proportion to Radiologist interpreted ultrasonographer performed DVT Ultrasound results.	5 minutes	No