Diagnostic Performance of General Practitioners in Compression UltraSound

Not Applicable

Recruiting

• Conditions: Deep Vein Thrombosis
• Interventions: Diagnostic Test: Compression ultrasound

• Registration Number: NCT05550038
• Lead Sponsor: University Hospital, Caen

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.

Study Timeline

• Study First Submitted: 2022-09-08
• Study First Submitted QC: 2022-09-19
• Study First Posted: 2022-09-22
• Study Start: 2022-10-03
• Status Verified: 2024-01
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-13
• Primary Completion: 2024-10-03
• Study Completion: 2024-10-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
compression ultrasound	Compression ultrasound	All patients receive a 3-point compression ultrasound followed within 72 hours by a whole-leg ultrasound with Doppler performed by a vascular physician.

Primary Outcome Measures

Name	Time	Method
Diagnostic performance of 3 point venous compression	72 hours	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)

Secondary Outcome Measures

Name	Time	Method
The evaluation of the feasibility of venous compression ultrasound in the office by the general practitioner.	72 hours	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.
Duration of the ultrasound performed by the general practitioner in minutes.	72 hours	Duration of the ultrasound performed by the general practitioner in minutes.
The interpretability of ultrasound images by general practitioners	72 hours	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.

Trial Locations

Locations (19)

Bayeux; 🇫🇷 Bayeux, Normandie, France

Avranches; 🇫🇷 Avranches, France

Bain de Bretagne; 🇫🇷 Bain-de-Bretagne, France

Colombelles; 🇫🇷 Colombelles, France

Condé sur vire; 🇫🇷 Condé sur vire, France

Honfleur; 🇫🇷 Honfleur, France

Ifs; 🇫🇷 Ifs, France

Le Chesnay; 🇫🇷 Le Chesnay, France

Le pont de montvert; 🇫🇷 Le Pont de Montvert, France

Lons-le-Saunier; 🇫🇷 Lons-le-Saunier, France

Le Molay Littry; 🇫🇷 Molay, France

Ouistreham; 🇫🇷 Ouistreham, France

Paris rue de Rome; 🇫🇷 Paris, France

Percy; 🇫🇷 Percy, France

Ploerdut; 🇫🇷 Ploerdut, France

Potigny; 🇫🇷 Potigny, France

Sannerville; 🇫🇷 Sannerville, France

Saix; 🇫🇷 Saïx, France

Troarn; 🇫🇷 Troarn, France