Diagnostic Performance of General Practitioners in Compression UltraSound (GPCUS)
September 19, 2024 updated by: University Hospital, Caen
Diagnostic Performance of General Practitioners in Compression Ultrasound for the Diagnosis of Proximal Deep Vein Thrombosis of the Lower Limbs
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Avranches, France, 50300
- Avranches
-
Bain-de-Bretagne, France, 35470
- Bain de Bretagne
-
Colombelles, France, 14460
- Colombelles
-
Condé sur vire, France, 50890
- Condé sur vire
-
Honfleur, France, 14600
- Honfleur
-
Ifs, France, 14123
- Ifs
-
Le Chesnay, France, 78150
- Le Chesnay
-
Le Pont de Montvert, France, 48220
- Le pont de montvert
-
Lons-le-Saunier, France, 39000
- Lons-le-Saunier
-
Molay, France, 14330
- Le Molay Littry
-
Ouistreham, France, 14150
- Ouistreham
-
Paris, France, 75017
- Paris rue de Rome
-
Percy, France, 50410
- Percy
-
Ploerdut, France, 56160
- Ploerdut
-
Potigny, France, 14420
- Potigny
-
Sannerville, France, 14940
- Sannerville
-
Saïx, France, 81710
- Saix
-
Troarn, France, 14670
- Troarn
-
-
Normandie
-
Bayeux, Normandie, France, 14400
- Bayeux
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 110 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Patients receive a 3-point compression ultrasound performed by the general practitioner to look for proximal deep vein thrombosis.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic performance of 3 point venous compression
Time Frame: 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)
|
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.
Time Frame: 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. |
72 hours
|
|
Duration of the ultrasound performed by the general practitioner in minutes.
Time Frame: 72 hours
|
Duration of the ultrasound performed by the general practitioner in minutes.
|
72 hours
|
|
The interpretability of ultrasound images by general practitioners
Time Frame: 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. |
72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas DELOMAS, Dr, Hospital Saint Lo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mumoli N, Vitale J, Giorgi-Pierfranceschi M, Sabatini S, Tulino R, Cei M, Bucherini E, Bova C, Mastroiacovo D, Camaiti A, Palmiero G, Puccetti L, Dentali F; PRACTICUS Study Investigators. General Practitioner-Performed Compression Ultrasonography for Diagnosis of Deep Vein Thrombosis of the Leg: A Multicenter, Prospective Cohort Study. Ann Fam Med. 2017 Nov;15(6):535-539. doi: 10.1370/afm.2109.
- Mumoli N, Vitale J, Cocciolo M, Cei M, Brondi B, Basile V, Sabatini S, Gambaccini L, Carrara I, Camaiti A, Giuntoli S, Dentali F. Accuracy of nurse-performed compression ultrasonography in the diagnosis of proximal symptomatic deep vein thrombosis: a prospective cohort study. J Thromb Haemost. 2014 Apr;12(4):430-5. doi: 10.1111/jth.12522.
- Pomero F, Dentali F, Borretta V, Bonzini M, Melchio R, Douketis JD, Fenoglio LM. Accuracy of emergency physician-performed ultrasonography in the diagnosis of deep-vein thrombosis: a systematic review and meta-analysis. Thromb Haemost. 2013 Jan;109(1):137-45. doi: 10.1160/TH12-07-0473. Epub 2012 Nov 8.
- Lee JH, Lee SH, Yun SJ. Comparison of 2-point and 3-point point-of-care ultrasound techniques for deep vein thrombosis at the emergency department: A meta-analysis. Medicine (Baltimore). 2019 May;98(22):e15791. doi: 10.1097/MD.0000000000015791.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 3, 2022
Primary Completion (Actual)
January 23, 2024
Study Completion (Actual)
January 23, 2024
Study Registration Dates
First Submitted
September 8, 2022
First Submitted That Met QC Criteria
September 19, 2022
First Posted (Actual)
September 22, 2022
Study Record Updates
Last Update Posted (Actual)
September 20, 2024
Last Update Submitted That Met QC Criteria
September 19, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-0114
- 22.02437.000091 (Other Identifier: CPP OUEST II)
- 2022-A01244-39 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.