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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-10

Study Completion Date

2016-10-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Deep Vein Thrombosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Suspected first episode of DVT

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

Group Type OTHER

portable venous compression ultrasonography

Intervention Type PROCEDURE

venous compression ultrasonography performed using an ultra-portable ultrasound device (by emergency physician)

venous compress ultrasonography

Intervention Type PROCEDURE

venous compression ultrasonography performed using a classic ultrasound device (by exploratory specialist)

Doppler ultrasound of the lower limbs

Intervention Type PROCEDURE

Doppler ultrasound of the lower limbs (gold standard; by exploratory specialist)

Interventions

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portable venous compression ultrasonography

venous compression ultrasonography performed using an ultra-portable ultrasound device (by emergency physician)

Intervention Type PROCEDURE

venous compress ultrasonography

venous compression ultrasonography performed using a classic ultrasound device (by exploratory specialist)

Intervention Type PROCEDURE

Doppler ultrasound of the lower limbs

Doppler ultrasound of the lower limbs (gold standard; by exploratory specialist)

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No