PneumoniaEPEMedGNCT04127149
Evaluation of Ultra-portable Ultrasound in General Practice
A study testing Ultrasound scan in people with Pneumonia and Pleural Effusion, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Pleural Effusion, Renal Colic
- What is being tested?
- Ultrasound scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteFrance
- Study dates
- 3 Dec 2019to 20 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients age 18 and over
- consulting their general practitioner for one of the 8 conditions below
Who cannot join
- patients who have already received an imagery exam for the acute episode justifying the consult
- opposition to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pragmatic Evaluation of Ultra-portable Ultrasound for a List of Indications in General Practice
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.
Read more
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
- Pneumonia, Pleural Effusion, Renal Colic, Hepatic Colic or Cholecystitis, Subcutaneous Abscess or Cyst, Fracture of Long Bones
- Being tested
- Ultrasound scan
- Keywords
- ultrasound scanner, sonogram, general practice
- Medical subject headings
- Pneumonia, Pleural Effusion, Renal Colic, Cholecystitis, Cysts, Pregnancy, Ectopic, Abortion, Spontaneous, Phlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound scanDiagnostic test
The group uses an ultrasound device for the consultation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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…)
Measured: Two weeks after inclusion
Secondary outcomes (4)
Number of hospitalisations, specialist orientation or return home
Two weeks after the initial consultation, with or without ultrasound scanners, the general practitioners call their patients to know if within the past two weeks, they have been hospitalised, required emergency care, needed to consult a specialist, or returned back home
Measured: Two weeks after inclusion
Cost of care
After knowing the patient orientation and the complementary exams they had, an estimation of the cost of care is made.
Measured: Four weeks after inclusion in the study
Anxiety score measured by the State-Trait Anxiety Inventory (STAI-Y) scale
Two weeks after the initial consultation, with or without ultrasound scanners, the general practitioners call their patients to know the result of the anxiety test they took the day of the first consultation.
Measured: Two weeks after inclusion in the study
Consultation duration
The day of the first consultation, the general practitioner writes the time spent
Measured: Two weeks after inclusion in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start3 Dec 2019
- Primary completion20 Oct 2021
- Study completion20 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis PELLET, MD, Principal investigator, Maison de sante pluridisciplinaire Leopold Ollier Les Vans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127149
- Sponsor's protocol ID
- 69HCL18_1004
- Acronym
- EPEMedG
- Status last verified
- Dec 2025
- First submitted
- 8 Oct 2019
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Evaluation of Ultra-portable Ultrasound for a List of Indications in General Practice
- ClinicalTrials.gov ID
- NCT04127149
- Acronym / sponsor ID
- EPEMedG / 69HCL18_1004
- Conditions
- Pneumonia, Pleural Effusion, Renal Colic, Hepatic Colic or Cholecystitis, Subcutaneous Abscess or Cyst, Fracture of Long Bones
- Keywords
- ultrasound scanner, sonogram, general practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with ultrasound | Experimental | Diagnostic Test: Ultrasound scanThe 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 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients age 18 and over
- consulting their general practitioner for one of the 8 conditions below
Key exclusion criteria (2 listed)
- patients who have already received an imagery exam for the acute episode justifying the consult
- opposition to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound scanThe group uses an ultrasound device for the consultation. | Diagnostic test | Group with ultrasound |
Primary outcome
Number of complementary exams
Time frame: Two weeks after inclusion
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…)
4 secondary outcomes
Number of hospitalisations, specialist orientation or return home
Time frame: Two weeks after inclusion
Cost of care
Time frame: Four weeks after inclusion in the study
Anxiety score measured by the State-Trait Anxiety Inventory (STAI-Y) scale
Time frame: Two weeks after inclusion in the study
Consultation duration
Time frame: Two weeks after inclusion in the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publicationDasse-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis PELLET, MD principal investigator
Maison de sante pluridisciplinaire Leopold Ollier Les Vans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound scan in people with Pneumonia and Pleural Effusion, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of complementary exams (time frame: Two weeks after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04127149, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.