Evaluation of Ultra-portable Ultrasound in General Practice

NCT04127149 | Completed

• 1 other identifier: 69HCL18_1004
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

ultrasound scanner; sonogram; general practice

Outcome Measures

Primary Outcomes (1)

• Number of complementary exams

  Two weeks after the initial consultation, with or without ultrasound scanners, the general practitioners call their patients to know: * The number of imagery exams they had (ultrasound, MRI, scanner, radiology…) * The number of biological analysis (CRP, ASAT, ALAT, Lipase…)

  Two weeks after inclusion

Secondary Outcomes (4)

• Number of hospitalisations, specialist orientation or return home

  Two weeks after inclusion

• Cost of care

  Four weeks after inclusion in the study

• Anxiety score measured by the State-Trait Anxiety Inventory (STAI-Y) scale

  Two weeks after inclusion in the study

• Consultation duration

  Two weeks after inclusion in the study

Study Arms (2)

Group with ultrasound

EXPERIMENTAL

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.

Diagnostic Test: Ultrasound scan

Group without ultrasound

NO INTERVENTION

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.

Interventions

Ultrasound scan DIAGNOSTIC_TEST

The group uses an ultrasound device for the consultation.

Group with ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patients who have already received an imagery exam for the acute episode justifying the consult
• opposition to participate

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Maison de santé pluridisciplinaire Léopold Ollier

Les Vans, 07140, France

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Pneumonia; Pleural Effusion; Renal Colic; Cholecystitis; Cysts; Pregnancy, Ectopic; Abortion, Spontaneous; Phlebitis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Pleural Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Neoplasms; Pathological Conditions, Anatomical; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Francis PELLET, MD

  Maison de sante pluridisciplinaire Leopold Ollier Les Vans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 15, 2019
• Study Start: December 3, 2019
• Primary Completion: October 20, 2021
• Study Completion: October 20, 2021
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (1)