Diagnostic Performance of General Practitioners in Compression UltraSound

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the diagnostic efficiency of general practitioners for the diagnosis of proximal deep vein thrombosis of the lower limbs compared with whole-leg ultrasound with Doppler performed by the vascular physician.

Detailed Description
-----------------
After being informed about the study and the potential risks, all patients who have given their written consent and who meet the eligibility criteria will benefit from a 3-point compression ultrasound performed by the general practitioner before being referred for a whole-leg ultrasound with Doppler at the vascular physician.

Official Title
-----------------
Diagnostic Performance of General Practitioners in Compression Ultrasound for the Diagnosis of Proximal Deep Vein Thrombosis of the Lower Limbs

Conditions
-----------------
Deep Vein Thrombosis

Intervention / Treatment
-----------------
* Diagnostic Test: Compression ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 years Management by a general practitioner trained in 3-point venous ultrasound Suspicion of deep vein thrombosis by the general practitioner with prescription of a whole-leg Doppler ultrasound by a vascular physician. It is noted that the patient can be included from the moment the general practitioner had planned to refer the patient to the vascular physician for a suspicion of DVT, including in the absence of realization of DDimer on a low probability of DVT. It may also be included in case of positive DDimer tests. Signed written consent Patient covered by the French social security system Exclusion Criteria: Whole leg ultrasound performed more than 72 hours after the initial examination History of homolateral deep vein thrombosis Patient objecting to the use of his data Refusal of written and signed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: All included patients will have a compression ultrasound performed by the general practitioner followed within 72 hours by a whole leg ultrasound with Doppler performed by the vascular physician.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: compression ultrasound<br>All patients receive a 3-point compression ultrasound followed within 72 hours by a whole-leg ultrasound with Doppler performed by a vascular physician. | Diagnostic Test: Compression ultrasound<br>* Patients receive a 3-point compression ultrasound performed by the general practitioner to look for proximal deep vein thrombosis.<br>* Other names: three-point point-of-care ultrasound technique;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of 3 point venous compression | The diagnostic performance (Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value) of 3-point venous compression ultrasound performed by general practitioners for the diagnosis of proximal venous thrombosis of the lower limbs compared to the usual recommended examination (whole leg ultrasound by a vascular physician) | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The evaluation of the feasibility of venous compression ultrasound in the office by the general practitioner. | For each patient, the general practitioner must say whether or not he or she was successful in performing the compression ultrasound. The measure will be the percentage of ultrasound examinations considered successful by general practitioners. | 72 hours | 
| Duration of the ultrasound performed by the general practitioner in minutes. | Duration of the ultrasound performed by the general practitioner in minutes. | 72 hours | 
| The interpretability of ultrasound images by general practitioners | The interpretability of ultrasound images by general practitioners. For each patient, the general practitioner must note the result of his or her ultrasound (compressibility or total incompressibility of the veins on the 3 points studied). He must also correctly interpret the ultrasound result (presence of venous thrombosis in case of total incompressibility of the vein or absence of thrombosis in case of total compressibility of the vein). The measure will be the percentage of correct interpretation of the compression test. | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DVT, Vein thrombosis, Thrombophlebitis