COVIDLUS-COVID19NCT04393402
Lung Ultrasound Score in Covid 19 Infectious Disease in Critical Care (LUS-COVID19)
An observational study of COVID, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
It might be necessary with Sars-Cov2 pneumopathy patient to repeat thoracic images, the tomodensitometry ones in particular. This task is difficult and nearly impossible for several reasons: respiratory and hemodynamic unstable patient, prone position and due to the high contagious nature of the disease. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- COVID
- What is being tested?
- lung ultrasound (LUS)
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2020to 31 Dec 2022
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with diagnose of Covid 19 by usully method, and admitted in critical care unit for oxygen-therapy or ventilatory support.
Who may be able to join
- Diagnosed Sars-Cov2 patient, with PCR method qualitative or quantitative as usual.
- Intensive or critical care admission
- ARDS with PaO2/FiO2 <300 at the admission
- Ventilatory support or oxygen-therapy
Who cannot join
- Age < 18 years-old
- Pregnancy
- Patient with tutor- or curatorship or in prison
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lung Ultrasound Score in Covid 19 Infectious Disease in Critical Care
It might be necessary with Sars-Cov2 pneumopathy patient to repeat thoracic images, the tomodensitometry ones in particular. This task is difficult and nearly impossible for several reasons: respiratory and hemodynamic unstable patient, prone position and due to the high contagious nature of the disease.
The lung ultrasound is an easy tool, fast (between 5 and 10 minutes) and as a limited training.
Read more
In the context of the Sars-Cov2 epidemic, Buonsenso and al case report depict the first lung ultrasound for a Covid 19 patient.
Peng and al in Intensive Care Medicine accentuate the usefulness of this particular technic.
In the American Journal of Respiratory and Critical Care Medicine, a study has been published as a point-of-care, in which the doctors reported using the lung ultrasound with intensive and critical care patient.
In Critical Care 2016, it has been showed that ultrasound allowed with neat precisions, to predict severe ARDS patient response to the prone position, all-cause.
Another researchers team found a good correlation between lung ultrasound, the SOFA, APACHE II, CPIS score, and patient mortality.
And a new applicability in the pulmonary recruitment by PEEP titration has been presented.
The aim of this study is to evaluate the lung ultrasound in Covid19 ARDS.
- Conditions
- COVID
- Being tested
- lung ultrasound (LUS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung ultrasound (LUS)Procedure or surgery
Patients with Covid-19 Disease and admitted in critical care unit will be performed a LUS
| Study group | Role | What they receive |
|---|---|---|
| Patients with Covid-19 and admitted in critical care unit | Not described Receives: Procedure: lung ultrasound (LUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
LUS applicability with COVID 19
In dorsal position, or in prone position, the two hemithorax will be subdivided in 6 parts, and a score will be attributed with the following criteria : A-Lines (0 point), > 3 B-lines (1 point), B-Lines coalscent (2 points), and pulmonary consolidation (3 points). For the echography we can use a convexe sonde, or a "cardiac" sonde.
Measured: 10 months
Secondary outcomes (3)
Radiographic correlation (chest Xray and tomodensitometry)
Comparison between Xray / CT scan exam and LUS
Measured: 10 months
LUS Mortality prediction
according to LUS score, ventilatory mode and parameters, medical history and bood analysis results
Measured: 10 months
Prediction of Prone position response
comparison of LUS score depending of the position used for performing LUS
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start20 Mar 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393402
- Sponsor's protocol ID
- 20reamedcovid03
- Acronym
- LUS-COVID19
- Status last verified
- Apr 2025
- First submitted
- 15 May 2020
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data sharing plan has been established
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound Score in Covid 19 Infectious Disease in Critical Care
- ClinicalTrials.gov ID
- NCT04393402
- Acronym / sponsor ID
- LUS-COVID19 / 20reamedcovid03
- Conditions
- COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 May 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.
It might be necessary with Sars-Cov2 pneumopathy patient to repeat thoracic images, the tomodensitometry ones in particular. This task is difficult and nearly impossible for several reasons: respiratory and hemodynamic unstable patient, prone position and due to the high contagious nature of the disease.
The lung ultrasound is an easy tool, fast (between 5 and 10 minutes) and as a limited training.
In the context of the Sars-Cov2 epidemic, Buonsenso and al case report depict the first lung ultrasound for a Covid 19 patient.
Peng and al in Intensive Care Medicine accentuate the usefulness of this particular technic.
In the American Journal of Respiratory and Critical Care Medicine, a study has been published as a point-of-care, in which the doctors reported using the lung ultrasound with intensive and critical care patient.
In Critical Care 2016, it has been showed that ultrasound allowed with neat precisions, to predict severe ARDS patient response to the prone position, all-cause.
Another researchers team found a good correlation between lung ultrasound, the SOFA, APACHE II, CPIS score, and patient mortality.
And a new applicability in the pulmonary recruitment by PEEP titration has been presented.
The aim of this study is to evaluate the lung ultrasound in Covid19 ARDS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Covid-19 and admitted in critical care unit | – | Procedure: lung ultrasound (LUS) |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with diagnose of Covid 19 by usully method, and admitted in critical care unit for oxygen-therapy or ventilatory support.
Key inclusion criteria (4 listed)
- Diagnosed Sars-Cov2 patient, with PCR method qualitative or quantitative as usual.
- Intensive or critical care admission
- ARDS with PaO2/FiO2 <300 at the admission
- Ventilatory support or oxygen-therapy
Key exclusion criteria (3 listed)
- Age < 18 years-old
- Pregnancy
- Patient with tutor- or curatorship or in prison
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 ultrasound (LUS)Patients with Covid-19 Disease and admitted in critical care unit will be performed a LUS | Procedure or surgery | Patients with Covid-19 and admitted in critical care unit |
Primary outcome
LUS applicability with COVID 19
Time frame: 10 months
In dorsal position, or in prone position, the two hemithorax will be subdivided in 6 parts, and a score will be attributed with the following criteria : A-Lines (0 point), > 3 B-lines (1 point), B-Lines coalscent (2 points), and pulmonary consolidation (3 points). For the echography we can use a convexe sonde, or a "cardiac" sonde.
3 secondary outcomes
Radiographic correlation (chest Xray and tomodensitometry)
Time frame: 10 months
LUS Mortality prediction
Time frame: 10 months
Prediction of Prone position response
Time frame: 10 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 10 Apr 2025.
- Individual participant dataSharing planned: No. No data sharing plan has been established
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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 COVID, run by Centre Hospitalier Universitaire de Nice 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 4 inclusion and 3 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 10 Apr 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?
LUS applicability with COVID 19 (time frame: 10 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 10 Apr 2025.