Location of Lower Extremity Deep Vein Thrombosis by Emergency Physicians Using Portable Compression Ultrasonography (EchoComp TVP)

Centre Hospitalier Universitaire de Nīmes

Status: Terminated

Conditions: Deep Vein Thrombosis

Treatments: Procedure: Doppler ultrasound of the lower limbs; Procedure: portable venous compression ultrasonography; Procedure: venous compress ultrasonography

Study type: Interventional

Funder types: Other

Identifiers

NCT02262494

2014-A00510-47 (Other Identifier)

LOCAL/2013/XB-01

Details and patient eligibility

About

The main objective of our study is to determine the diagnostic performance of an ultra-portable ultrasound (V-Scan®) device for emergency compression ultrasound when used by experienced ermergency doctors searching for proximal deep vein thrombosis (DVT) in patients with no history of DVT. The gold standard is Doppler ultrasound of the lower limbs performed by a vascular exploration expert.

Full description

The secondary objectives of this study are:

• to compare the diagnostic performance of emergency compression ultrasonography performed with and ultra-portable device (V-Scan®) with that of emergency compression ultrasonography performed with a classic device
• to compare the diagnostic performance of emergency compression ultrasonography between patients suspected of having DVT arriving through the emergency department versus similar patients sent in by their generalist
• to compare the diagnostic performance of emergency compression ultrasonography among patients with suspected DVT according to pre clinical probability testing based on the Wells score (low, medium or high probability).

Currently, the use of ultra-portable ultrasound in this indication is not part of routine care, and this study is therefore considered interventional in nature.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient must have given informed consent and signed consent
• The patient must be a member or beneficiary of a health insurance plan
• Patient consulting in the vascular exploration and medicine department for suspected first episode of deep vein thrombosis
• Ambulatory patient: defined as any outpatient coming in for a consult directly from their place of residence or via the emergency department
• Patient does not have a history of venous thromboembolism

Exclusion criteria

• The patient is participating in another study
• The patient is in an exclusion period determined by a previous study
• The patient is an adult under any kind of guardianship
• The patient refuses to sign the consent
• It is not possible to correctly inform the patient
• Patient has a history of venous thromboembolism

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

Suspected first episode of DVT

Other group

Description:

The study population consists of patients presenting with suspected first episode of DVT at the Nîmes University Hospital. Intervention: portable venous compression ultrasonography Intervention: venous compress ultrasonography Intervention: Doppler ultrasound of the lower limbs

Treatment:

Procedure: portable venous compression ultrasonography

Procedure: venous compress ultrasonography

Procedure: Doppler ultrasound of the lower limbs