Location of Lower Extremity Deep Vein Thrombosis by Emergency Physicians Using Portable Compression Ultrasonography

Not Applicable

Terminated

• Conditions: Deep Vein Thrombosis
• Interventions: Procedure: portable venous compression ultrasonography; Procedure: venous compress ultrasonography; Procedure: Doppler ultrasound of the lower limbs

• Registration Number: NCT02262494
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-10-02
• Study First Submitted QC: 2014-10-08
• Study First Posted: 2014-10-13
• Study Start: 2015-04-10
• Primary Completion: 2016-10-19
• Study Completion: 2016-10-19
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-02
• Last Update Posted: 2018-01-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Suspected first episode of DVT	venous compress ultrasonography	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
Suspected first episode of DVT	Doppler ultrasound of the lower limbs	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
Suspected first episode of DVT	portable venous compression ultrasonography	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

Primary Outcome Measures

Name	Time	Method
Diagnosis of deep vein thrombosis by portable ultrasound: yes/no	Day 0
Diagnosis of deep vein thrombosis by doppler ultrasound: yes/no	Day 0

Secondary Outcome Measures

Name	Time	Method
Wells score	Day 0	score ranging from 0 to 6
Diagnosis of deep vein thrombosis by classic ultrasound: yes/no	day 0

Trial Locations

Locations (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 9, France