GPCUS: Diagnostic Performance of General Practitioners in Compression UltraSound

• Sponsor: University Hospital, Caen (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05550038
• Collaborator: (none)
• Enrollment: 220
• Locations: 19
• Arm: 1
• Anticipated Duration (Months): 12
• Patients Per Site: 11.6
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Deep Vein Thrombosis	Diagnostic Test: Compression ultrasound	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 220 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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.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)
• Primary Purpose: Diagnostic
• Official Title: Diagnostic Performance of General Practitioners in Compression Ultrasound for the Diagnosis of Proximal Deep Vein Thrombosis of the Lower Limbs
• Actual Study Start Date: Oct 3, 2022
• Anticipated Primary Completion Date: Oct 3, 2023
• Anticipated Study Completion Date: Oct 3, 2023

Arms and Interventions

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.	Diagnostic Test: Compression ultrasound; Patients receive a 3-point compression ultrasound performed by the general practitioner to look for proximal deep vein thrombosis.; Other Names: three-point compression three-point compression ultrasound three-point point-of-care ultrasound technique

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. Duration of the ultrasound performed by the general practitioner in minutes. [72 hours]

   Duration of the ultrasound performed by the general practitioner in minutes.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 110 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bayeux	Bayeux	Normandie	France	14400
2	Avranches	Avranches		France	50300
3	Bain de Bretagne	Bain-de-Bretagne		France	35470
4	Colombelles	Colombelles		France	14460
5	Condé sur vire	Condé sur vire		France	50890
6	Honfleur	Honfleur		France	14600
7	Ifs	Ifs		France	14123
8	Le Chesnay	Le Chesnay		France	78150
9	Le pont de montvert	Le Pont de Montvert		France	48220
10	Lons-le-Saunier	Lons-le-Saunier		France	39000
11	Le Molay Littry	Molay		France	14330
12	Ouistreham	Ouistreham		France	14150
13	Paris rue de Rome	Paris		France	75017
14	Percy	Percy		France	50410
15	Ploerdut	Ploerdut		France	56160
16	Potigny	Potigny		France	14420
17	Sannerville	Sannerville		France	14940
18	Saix	Saïx		France	81710
19	Troarn	Troarn		France	14670

Sponsors and Collaborators

• University Hospital, Caen

Investigators

• Principal Investigator: Thomas DELOMAS, Dr, Hospital Saint Lo

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: University Hospital, Caen
• ClinicalTrials.gov Identifier: NCT05550038
• Other Study ID Numbers: 22-0114; 22.02437.000091; 2022-A01244-39
• First Posted: Sep 22, 2022
• Last Update Posted: Jan 5, 2023
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Caen: DVT; Vein thrombosis; Thrombophlebitis
• Additional relevant MeSH terms: Thrombosis; Venous Thrombosis

Study Results

No Results Posted as of Jan 5, 2023