Deep Vein Thrombosis
Conditions
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.
Interventions
PROCEDUREportable venous compression ultrasonography
venous compression ultrasonography performed using an ultra-portable ultrasound device (by emergency physician)
PROCEDUREvenous compress ultrasonography
venous compression ultrasonography performed using a classic ultrasound device (by exploratory specialist)
PROCEDUREDoppler ultrasound of the lower limbs
Doppler ultrasound of the lower limbs (gold standard; by exploratory specialist)
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis of deep vein thrombosis by classic ultrasound: yes/no | day 0 | — |
| Wells score | Day 0 | score ranging from 0 to 6 |
Countries
France
Outcome results
None listed