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Evaluation of Ultra-portable Ultrasound in General Practice

NCT ID: NCT04127149

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-03

Study Completion Date

2021-10-20

Brief Summary

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This is an interventional multi-centre study comparing two groups of general practitioners with or without an ultrasound scanner over a period of 6 months. The evaluation focuses on the management of patients for 8 pathologies:

* Pneumonia
* Pleural effusion
* Renal colic
* Hepatic colic or cholecystitis
* Subcutaneous abscess or cyst
* Fracture of long bones
* Intra-uterine pregnancy or extra-uterine pregnancy or miscarriage
* Phlebitis The principal hypothesis is that there are fewer complementary exams in the group of doctors using ultrasound scanners.

The secondary hypotheses are:

* There is better patient orientation (emergency care, specialist consultation, return home) in the group of doctors using the ultrasound scanners.
* The global cost of the care is lower in the group of doctors using the ultrasound.
* Using ultrasound during the consultation decreases the anxiety of the patient.
* Using ultrasound increases the duration of the consultation.
* There is no difference between the predicted and the real orientation of the patients.

Detailed Description

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Conditions

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Pneumonia Pleural Effusion Renal Colic Hepatic Colic or Cholecystitis Subcutaneous Abscess or Cyst Fracture of Long Bones Intra-uterine Pregnancy or Extra-uterine Pregnancy or Miscarriage Phlebitis

Keywords

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ultrasound scanner sonogram general practice

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Group with ultrasound

The first group consists of nine general practitioners having received a brief training on the use of ultrasound scanners in general practice. The general practitioner includes all adult patients who are consulting for one of the 8 medical conditions studied and perform an ultrasound scan. Two weeks later, he/she calls each patient to collect the necessary data.

Group Type EXPERIMENTAL

Ultrasound scan

Intervention Type DIAGNOSTIC_TEST

The group uses an ultrasound device for the consultation.

Group without ultrasound

The second group consists of nine general practitioners. Each physician includes all adult patients who are consulting for one of the 8 medical conditions studied and performs a standard consultation. Two weeks later, he/she calls each patient to collect the necessary data.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ultrasound scan

The group uses an ultrasound device for the consultation.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* patients age 18 and over
* consulting their general practitioner for one of the 8 conditions below

Exclusion Criteria

* patients who have already received an imagery exam for the acute episode justifying the consult
* opposition to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francis PELLET, MD

Role: PRINCIPAL_INVESTIGATOR

Maison de sante pluridisciplinaire Leopold Ollier Les Vans

Locations

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Maison de santé pluridisciplinaire Léopold Ollier

Les Vans, , France

Site Status

Countries

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France

References

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Dasse-Hartaut J, Couture S. Pragmatic evaluation of handheld point-of-care ultrasound in general practice. MD thesis. Claude Bernard University Lyon 1; 2021. Thesis supervisor: Dr Francis Pellet.

Reference Type RESULT

Other Identifiers

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69HCL18_1004

Identifier Type: -

Identifier Source: org_study_id