Focal Acute Respiratory Distress SyndromeLUVSNCT04966624
Ventilatory Strategy Based on Ultrasound Lung Morphology in Patients With Focal ARDS
A study testing LUVS" ventilatory strategy composed of a bundle of measures and Ventilatory management according to international recommendations (Société de Réanimation de la Langue Française) in people with Focal Acute Respiratory Distress Syndrome, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
ARDS is characterized by a diffuse, bilateral, extensive alveolar-interstitial infiltrate related to damage to the alveolar membrane. Studies of lung morphology assessed by CT scan have shown 2 types of ARDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Acute Respiratory Distress Syndrome
- What is being tested?
- LUVS" ventilatory strategy composed of a bundle of measures and Ventilatory management according to international recommendations (Société de Réanimation de la Langue Française)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2021to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- person who has given oral consent or has been included in an emergency
- Older than 18 years
- On mechanical ventilation for less than 24 hours
- Diagnosis of ARDS for less than 24 hours. ARDS according to the Berlin classification: i.e. arterial oxygen pressure to inspired oxygen fraction ratio less than or equal to 300, with a PEEP greater than or equal to 5, presence of bilateral radiological infiltrates not fully explained by heart failure or volume overload
- Focal ARDS determined on pulmonary ultrasound
Who cannot join
- person who is not a beneficiary of national health insurance
- person who is subject to a legal measure of protection (curatorship, guardianship)
- pregnant or breastfeeding women
- minor
- Patient having benefited from an invasive mechanical ventilation of more than one week in the previous month;
- ARDS in the previous month;
Show all 20Show fewer
- Chronic respiratory failure under NIV or long term oxygen;
- Severe acute asthma;
- Lobectomy;
- Pneumothorax;
- Pneumomediastinum;
- Pulmonary fibrosis;
- Morbid obesity with a BMI above 40 ;
- Cancer with metastasis;
- Bone marrow transplantation;
- Chemotherapy-induced neutropenia;
- Cirrhosis with a Child-Pugh score of C;
- Suspected or confirmed intracranial hypertension;
- Concurrent participation in another ARDS study;
- Extensive burns on the torso.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon, 21000
ABAGRI Sohel, sohel.abagri@chu-dijon.fr
About this study
ARDS is characterized by a diffuse, bilateral, extensive alveolar-interstitial infiltrate related to damage to the alveolar membrane.
Studies of lung morphology assessed by CT scan have shown 2 types of ARDS. When the loss of ventilation is posterior and caudal, and the pulmonary parenchyma is otherwise "healthy", ARDS is said to be focal. When the loss of ventilation is diffuse, associated with excess tissue affecting the entire lung parenchyma, ARDS is said to be non-focal or diffuse.
Read more
Only one recent multicenter study has evaluated whether individualized PEEP adjustment according to lung morphology (focal vs. non-focal) could improve ARDS survival outcomes compared with standard of care. Results for the primary endpoint, 90-day mortality, were negative. But lung morphology was misclassified on CT occurred 85 (21%) of 400 patients. In addition, per-protocol analysis in which misclassified patients were excluded showed that mortality was significantly lower in the personalized ventilation group than in the control group.
Lung ultrasound may be the ideal bedside imaging technique. The loss of pulmonary aeration and its variations induced by therapeutic maneuvers can be quantified by lung ultrasound. Lung ultrasound is a non-invasive, non-ionizing radiation method that can be easily used at the bedside.
APRV ventilation coupled with spontaneous breathing activity prevents atelectasis formation, recruits less ventilated areas, prevents mechanical ventilation-induced lung injury and improves lung compliance.
The hypothesis is that a "LUVS" ventilatory strategy composed of a bundle of measures all aiming at reopening the atelectatic pulmonary zones in focal ARDS (synergistic effect of spontaneous ventilation in APRV mode, early prone sessions, and adjustment of PEEP according to the patient's BMI), could decrease the number of days under mechanical ventilation, compared to protective ventilation with low tidal volume according to the current international recommendations
- Being tested
- LUVS" ventilatory strategy composed of a bundle of measures, Ventilatory management according to international recommendations (Société de Réanimation de la Langue Française)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUVS" ventilatory strategy composed of a bundle of measuresProcedure or surgery
Ventilation in APRV mode early prone sessions, adjustment of positive expiratory pressure according to the patient's BMI and no curarization
Ventilatory management according to international recommendations (Société de Réanimation de la Langue Française)Procedure or surgery
Ventilatory management according to international recommendations (Société de Réanimation de la Langue Française)
| Study group | Role | What they receive |
|---|---|---|
| interventional | Experimental | Not described Receives: Procedure: LUVS" ventilatory strategy composed of a bundle of measures |
| control | Active comparator | Not described Receives: Procedure: Ventilatory management according to international recommendations (Société de Réanimation de la Langue Française) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days without invasive ventilation
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start13 Oct 2021
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966624
- Sponsor's protocol ID
- BOUHEMAD Abagri 2021
- Acronym
- LUVS
- Status last verified
- Oct 2025
- First submitted
- 8 Jul 2021
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilatory Strategy Based on Ultrasound Lung Morphology in Patients With Focal ARDS
- ClinicalTrials.gov ID
- NCT04966624
- Acronym / sponsor ID
- LUVS / BOUHEMAD Abagri 2021
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 19 Jul 2021 (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.
ARDS is characterized by a diffuse, bilateral, extensive alveolar-interstitial infiltrate related to damage to the alveolar membrane.
Studies of lung morphology assessed by CT scan have shown 2 types of ARDS. When the loss of ventilation is posterior and caudal, and the pulmonary parenchyma is otherwise "healthy", ARDS is said to be focal. When the loss of ventilation is diffuse, associated with excess tissue affecting the entire lung parenchyma, ARDS is said to be non-focal or diffuse.
Only one recent multicenter study has evaluated whether individualized PEEP adjustment according to lung morphology (focal vs. non-focal) could improve ARDS survival outcomes compared with standard of care. Results for the primary endpoint, 90-day mortality, were negative. But lung morphology was misclassified on CT occurred 85 (21%) of 400 patients. In addition, per-protocol analysis in which misclassified patients were excluded showed that mortality was significantly lower in the personalized ventilation group than in the control group.
Lung ultrasound may be the ideal bedside imaging technique. The loss of pulmonary aeration and its variations induced by therapeutic maneuvers can be quantified by lung ultrasound. Lung ultrasound is a non-invasive, non-ionizing radiation method that can be easily used at the bedside.
APRV ventilation coupled with spontaneous breathing activity prevents atelectasis formation, recruits less ventilated areas, prevents mechanical ventilation-induced lung injury and improves lung compliance.
The hypothesis is that a "LUVS" ventilatory strategy composed of a bundle of measures all aiming at reopening the atelectatic pulmonary zones in focal ARDS (synergistic effect of spontaneous ventilation in APRV mode, early prone sessions, and adjustment of PEEP according to the patient's BMI), could decrease the number of days under mechanical ventilation, compared to protective ventilation with low tidal volume according to the current international recommendations
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional | Experimental | Procedure: LUVS" ventilatory strategy composed of a bundle of measures |
| control | Active comparator | Procedure: Ventilatory management according to international recommendations (Société de Réanimation de la Langue Française) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- person who has given oral consent or has been included in an emergency
- Older than 18 years
- On mechanical ventilation for less than 24 hours
- Diagnosis of ARDS for less than 24 hours. ARDS according to the Berlin classification: i.e. arterial oxygen pressure to inspired oxygen fraction ratio less than or equal to 300, with a PEEP greater than or equal to 5, presence of bilateral radiological infiltrates not fully explained by heart failure or volume overload
- Focal ARDS determined on pulmonary ultrasound
Key exclusion criteria (20 listed)
- person who is not a beneficiary of national health insurance
- person who is subject to a legal measure of protection (curatorship, guardianship)
- pregnant or breastfeeding women
- minor
- Patient having benefited from an invasive mechanical ventilation of more than one week in the previous month;
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 |
|---|---|---|
| LUVS" ventilatory strategy composed of a bundle of measuresVentilation in APRV mode early prone sessions, adjustment of positive expiratory pressure according to the patient's BMI and no curarization | Procedure or surgery | interventional |
| Ventilatory management according to international recommendations (Société de Réanimation de la Langue Française)Ventilatory management according to international recommendations (Société de Réanimation de la Langue Française) | Procedure or surgery | control |
Primary outcome
Number of days without invasive ventilation
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LUVS" ventilatory strategy composed of a bundle of measures and Ventilatory management according to international recommendations (Société de Réanimation de la Langue Française) in people with Focal Acute Respiratory Distress Syndrome, run by Centre Hospitalier Universitaire Dijon 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 5 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 25 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BOUHEMAD Belaid (03 80 29 30 79, belaid.bouhemad@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days without invasive ventilation (time frame: 28 days). 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 2025.