UltrasonographyAmBulUsNCT04644510
Feasability of Lung Ultrasonography in General Practice
An observational study of Ultrasonography and Education, run by University Hospital, Caen at 1 site in France.
Trial summary
A major barrier to ultrasonography in general practice (GP) is the time restriction of their medical consultation. We aimed to evaluate the feasibility of lung ultrasonography (LUS) realized by general practitioners (GP's) into their medical consultation. Read more about this study
- Who is it for?
- Ages 3 months and older
- Conditions the study is for
- Ultrasonography, Education, General Practice
- What is being tested?
- Lung ultrasonography
- Type of treatment
- Medical device
- How many people
- 111 participants
- Where
- 1 siteFrance
- Study dates
- 17 Dec 2019to 31 Jan 2020
- Phase
- Observational
- 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 3 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients consulting their family physician
Who may be able to join
- Age > 3 months; lung ultrasonography performed by GP
Who cannot join
- Age < 3 months or rejection to participate to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasability of Lung Ultrasonography in General Practice: A Multicentic, Observational and Descriptive Study
A major barrier to ultrasonography in general practice (GP) is the time restriction of their medical consultation. We aimed to evaluate the feasibility of lung ultrasonography (LUS) realized by general practitioners (GP's) into their medical consultation.
A prospective, observational, multi-centric and open study conducted in 3 different centers by 15 GP in France. Patient receiving LUS were recruited from December 2019 to January 2020. GP's were all novices and received a training course by LUS expert before the study. Eight-points LUS exam was recorded, timed, and interpreted by GP's.
Read more
Among the 111 LUS performed, 110 LUS were interpreted. Time duration was 4 (3-5) min with 13% of LUS superior to 5 minutes. There was no significant difference in time duration after stratification by age. Patients were mainly satisfied after receiving LUS, and 80% of patients had a better understanding about their disease due to US realization.
In this first prospective, and multicenter study, involving patients consulting in General Practice, we found that LUS seems to be feasible by GP's in a medical consultation. We showed that LUS can be performed fast enough for a GP consultation, and easy to learn. These findings will need to be valided in a randomized and controlled study.
- Conditions
- Ultrasonography, Education, General Practice
- Being tested
- Lung ultrasonography
- Keywords
- Ultrasonography, General Practice, Feasability, Lung ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasonographyDevice
Standardized eight-point Lung ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| Lung ultrasonography group | Patient which benefited from a Lung ultrasonography during the medical consultation Receives: Device: Lung ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Lung Ultrasonography
Measured: 2 months
Secondary outcomes (4)
Time limit exceeded lung ultrasonography
Superior to 5 minutes
Measured: 2 months
Interpretation of lung ultrasonography images
Measured: 2 months
Stratification by age
3 groups : < 18 years-old, 18-65 years-old, > 65 years-old
Measured: 2 months
Survey results
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start17 Dec 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasonographyStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644510
- Sponsor's protocol ID
- 19-023
- Other IDs
- 2019-A00205-52
- Acronym
- AmBulUs
- Status last verified
- Nov 2020
- First submitted
- 20 Nov 2020
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasability of Lung Ultrasonography in General Practice: A Multicentic, Observational and Descriptive Study
- ClinicalTrials.gov ID
- NCT04644510
- Acronym / sponsor ID
- AmBulUs / 19-023
- Conditions
- Ultrasonography, Education, General Practice
- Keywords
- Ultrasonography, General Practice, Feasability, Lung ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 25 Nov 2020 (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.
A major barrier to ultrasonography in general practice (GP) is the time restriction of their medical consultation. We aimed to evaluate the feasibility of lung ultrasonography (LUS) realized by general practitioners (GP's) into their medical consultation.
A prospective, observational, multi-centric and open study conducted in 3 different centers by 15 GP in France. Patient receiving LUS were recruited from December 2019 to January 2020. GP's were all novices and received a training course by LUS expert before the study. Eight-points LUS exam was recorded, timed, and interpreted by GP's.
Among the 111 LUS performed, 110 LUS were interpreted. Time duration was 4 (3-5) min with 13% of LUS superior to 5 minutes. There was no significant difference in time duration after stratification by age. Patients were mainly satisfied after receiving LUS, and 80% of patients had a better understanding about their disease due to US realization.
In this first prospective, and multicenter study, involving patients consulting in General Practice, we found that LUS seems to be feasible by GP's in a medical consultation. We showed that LUS can be performed fast enough for a GP consultation, and easy to learn. These findings will need to be valided in a randomized and controlled study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung ultrasonography group | – | Device: Lung ultrasonographyPatient which benefited from a Lung ultrasonography during the medical consultation |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients consulting their family physician
Key inclusion criteria (1 listed)
- Age > 3 months; lung ultrasonography performed by GP
Key exclusion criteria (1 listed)
- Age < 3 months or rejection to participate to the study
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 |
|---|---|---|
| Lung ultrasonographyStandardized eight-point Lung ultrasonography | Device | Lung ultrasonography group |
Primary outcome
Duration of Lung Ultrasonography
Time frame: 2 months
4 secondary outcomes
Time limit exceeded lung ultrasonography
Time frame: 2 months
Interpretation of lung ultrasonography images
Time frame: 2 months
Stratification by age
Time frame: 2 months
Survey results
Time frame: 2 months
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 25 Nov 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasonography and Education, run by University Hospital, Caen 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 1 inclusion and 1 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 25 Nov 2020. 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?
Duration of Lung Ultrasonography (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2020.