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Diagnostic Performance of General Practitioners in Compression UltraSound (GPCUS)

Primary Purpose

Deep Vein Thrombosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Compression ultrasound
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Deep Vein Thrombosis focused on measuring DVT, Vein thrombosis, Thrombophlebitis

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • BayeuxRecruiting
  • AvranchesRecruiting
  • Bain de BretagneRecruiting
  • ColombellesRecruiting
  • Condé sur vireRecruiting
  • HonfleurRecruiting
  • IfsRecruiting
  • Le ChesnayRecruiting
  • Le pont de montvertRecruiting
  • Lons-le-SaunierRecruiting
  • Le Molay LittryRecruiting
  • OuistrehamRecruiting
  • Paris rue de RomeRecruiting
  • PercyRecruiting
  • PloerdutRecruiting
  • PotignyRecruiting
  • SannervilleRecruiting
  • SaixRecruiting
  • TroarnRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

compression ultrasound

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
September 8, 2022
Last Updated
January 4, 2023
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT05550038
Brief Title
Diagnostic Performance of General Practitioners in Compression UltraSound
Acronym
GPCUS
Official Title
Diagnostic Performance of General Practitioners in Compression Ultrasound for the Diagnosis of Proximal Deep Vein Thrombosis of the Lower Limbs
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
October 3, 2023 (Anticipated)
Study Completion Date
October 3, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis
Keywords
DVT, Vein thrombosis, Thrombophlebitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
compression ultrasound
Arm Type
Experimental
Arm Description
All patients receive a 3-point compression ultrasound followed within 72 hours by a whole-leg ultrasound with Doppler performed by a vascular physician.
Intervention Type
Diagnostic Test
Intervention Name(s)
Compression ultrasound
Other Intervention Name(s)
three-point compression, three-point compression ultrasound, three-point point-of-care ultrasound technique
Intervention Description
Patients receive a 3-point compression ultrasound performed by the general practitioner to look for proximal deep vein thrombosis.
Primary Outcome Measure Information:
Title
Diagnostic performance of 3 point venous compression
Description
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)
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
The evaluation of the feasibility of venous compression ultrasound in the office by the general practitioner.
Description
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.
Time Frame
72 hours
Title
Duration of the ultrasound performed by the general practitioner in minutes.
Description
Duration of the ultrasound performed by the general practitioner in minutes.
Time Frame
72 hours
Title
The interpretability of ultrasound images by general practitioners
Description
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.
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
THOMAS DELOMAS, Dr
Phone
+33603786064
Email
thomas.delomas@ch-stlo.fr
First Name & Middle Initial & Last Name or Official Title & Degree
CHAILLOT Fabien
Phone
+33231065774
Email
chaillot-f@chu-caen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas DELOMAS, Dr
Organizational Affiliation
Hospital Saint Lo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bayeux
City
Bayeux
State/Province
Normandie
ZIP/Postal Code
14400
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johann GUILLET, Dr
Phone
+33231927434
Email
docteurjohannguillet@gmail.com
First Name & Middle Initial & Last Name & Degree
Johann GUILLET, Dr
First Name & Middle Initial & Last Name & Degree
François SANOUILLER, Dr
Facility Name
Avranches
City
Avranches
ZIP/Postal Code
50300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane SOLTY, Dr
Phone
+3333790099
Email
drsolty@orange.fr
First Name & Middle Initial & Last Name & Degree
Stéphane SOLTY, Dr
Facility Name
Bain de Bretagne
City
Bain-de-Bretagne
ZIP/Postal Code
35470
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud MAURY, Dr
Phone
+33299438687
Email
arnaud.maury@protonmail.com
First Name & Middle Initial & Last Name & Degree
Arnaud MAURY, Dr
Facility Name
Colombelles
City
Colombelles
ZIP/Postal Code
14460
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LEBAS Jeanne, Dr
Phone
+33231724006
Email
jeanne.lebas@gmail.com
First Name & Middle Initial & Last Name & Degree
Jeanne LEBAS, Dr
First Name & Middle Initial & Last Name & Degree
Stephane VALLAEYS, Dr
Facility Name
Condé sur vire
City
Condé sur vire
ZIP/Postal Code
50890
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck DUJARDIN, Dr
Phone
+33233565037
Email
docteur.dujardin@wanadoo.fr
First Name & Middle Initial & Last Name & Degree
Franck DUJARDIN, Dr
Facility Name
Honfleur
City
Honfleur
ZIP/Postal Code
14600
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas VASTEL, Dr
Phone
+33231988100
Email
thomasvastel@hotmail.com
First Name & Middle Initial & Last Name & Degree
Thomas VASTEL, Dr
Facility Name
Ifs
City
Ifs
ZIP/Postal Code
14123
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanne BOUTEMY, Dr
Phone
+33231340974
Email
j.boutemy@medsyn.fr
First Name & Middle Initial & Last Name & Degree
Jeanne BOUTEMY, Dr
Facility Name
Le Chesnay
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Audrey ATLAN-COTTIN, Dr
Phone
+33139499901
Email
dratlancottin@gmail.com
First Name & Middle Initial & Last Name & Degree
Audrey ATLAN-COTTIN, Dr
Facility Name
Le pont de montvert
City
Le Pont de Montvert
ZIP/Postal Code
48220
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evelyne MERTZ, Dr
Phone
+33411290010
Email
evelynemertz@gmail.com
First Name & Middle Initial & Last Name & Degree
Evelyne MERTZ, Dr
Facility Name
Lons-le-Saunier
City
Lons-le-Saunier
ZIP/Postal Code
39000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre BOISSARD, Dr
Phone
+33384249090
Email
p.boissard@mutualite-39.fr
First Name & Middle Initial & Last Name & Degree
Pierre BOISSARD, Dr
Facility Name
Le Molay Littry
City
Molay
ZIP/Postal Code
14330
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier MOULIN, Dr
Phone
+33231100528
Email
dratlancottin@gmail.com
First Name & Middle Initial & Last Name & Degree
Olivier MOULIN, Dr
Facility Name
Ouistreham
City
Ouistreham
ZIP/Postal Code
14150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Céline LEMARINIER, Dr
Phone
+33231971845
Email
clemarinier@orange.fr
First Name & Middle Initial & Last Name & Degree
Céline LEMARINIER, Dr
First Name & Middle Initial & Last Name & Degree
Laurent RACHINE, Dr
Facility Name
Paris rue de Rome
City
Paris
ZIP/Postal Code
75017
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delphine MONNIER, Dr
Phone
+33147425109
Email
dr.delphine.monnier@gmail.com
First Name & Middle Initial & Last Name & Degree
Delphine MONNIER, Dr
Facility Name
Percy
City
Percy
ZIP/Postal Code
50410
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cédric LABEAU, Dr
Phone
+33233511669
Email
labced@hotmail.fr
First Name & Middle Initial & Last Name & Degree
Cédric LABEAU, Dr
Facility Name
Ploerdut
City
Ploerdut
ZIP/Postal Code
56160
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tith PILOT, Dr
Phone
+33297397700
Email
tithpilot@hotmail.com
Facility Name
Potigny
City
Potigny
ZIP/Postal Code
14420
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fidélis EKPO, Dr
Phone
+33231908171
Email
ekpo.fidelis@gmail.com
First Name & Middle Initial & Last Name & Degree
Fidélis EKPO, Dr
Facility Name
Sannerville
City
Sannerville
ZIP/Postal Code
14940
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexis AUBERT, Dr
Phone
+33231306913
Email
dr.aubert.a@gmail.com
First Name & Middle Initial & Last Name & Degree
Alexis AUBERT, Dr
Facility Name
Saix
City
Saïx
ZIP/Postal Code
81710
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Violeta MILU, Dr
Phone
+33563704620
Email
violetamilu30@yahoo.com
First Name & Middle Initial & Last Name & Degree
Violeta MILU, Dr
Facility Name
Troarn
City
Troarn
ZIP/Postal Code
14670
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas ECOLIVET, Dr
Phone
+33231233233
Email
thomas.ecolivet@gmail.com
First Name & Middle Initial & Last Name & Degree
Thomas ECOLIVET, Dr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29133492
Citation
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.
Results Reference
background
PubMed Identifier
24495051
Citation
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.
Results Reference
background
PubMed Identifier
23138420
Citation
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.
Results Reference
background
PubMed Identifier
31145304
Citation
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.
Results Reference
background

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Diagnostic Performance of General Practitioners in Compression UltraSound

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