ARDSNCT02149589
Lung Imaging for Ventilatory Setting in ARDS
A study testing Mechanical ventilation in people with ARDS, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
To compare in ARDS patients 2 ventilatory Strategies : One based on Lung Morphology (Focal versus non-Focal ARDS) versus ARDS networks Guidelines (PEEP based on FiO2). In Focal ARDS prone position will be promote early, with low PEEP and moderate Vt. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS
- What is being tested?
- Mechanical ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to 2 Feb 2018
- 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
- Man or female older than 18 years
- ARDS since less than 12 hours
- PaO2 / FiO2 < 200 avec une PEEP ≥ 5 (Berlin Moderate or severe)
Who cannot join
- brain injury with high ICP
- BMT Liver Cirrhosis Child C Pregnancy Burns Morbid obese patients (BMI > 40) Moribund
Trial locations and contacts
1 site in 1 country.
About this study
To compare in ARDS patients 2 ventilatory Strategies : One based on Lung Morphology (Focal versus non-Focal ARDS) versus ARDS networks Guidelines (PEEP based on FiO2). In Focal ARDS prone position will be promote early, with low PEEP and moderate Vt. In non-Focal ARDS, Recruitment maneuvers, high PEEP and low V twill be used.
The investigators made the hypothesis that ventilation according to Lung morphology my decrease mortality at D90.
Read the detailed description
Early ARDS, less than 12 hours will be included. After Lung imaging, they will be randomized to a control group (PEEP/FiO2 according to ARDSnetwork tables) or an intervention arm. In this arm, mechanical ventilation will be set according to lung morphology. In patients with focal ARDS, prone position will be start quickly for at least 16 hours. After, A low PEEP and 8ml/kg of PBWwill be used. In non-focal ARDS, a recruitment maneuver followed by a high PEEP and a small tidal volume strategy will be used. In both arms, patients will be sedated and paralyzed during maximum 48 hours. As soon as PaO2/FiO2 > 200 mmHG, myorelaxant and sedation will be withdrawal. Pressure support ventilation will be used as soon as possible and weaning from ventilation will be checked everyday
- Conditions
- ARDS
- Being tested
- Mechanical ventilation
- Keywords
- ARDS, PEEP, Recruitment manoeuvres, Lung Morphology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Focal ARDS | Experimental | In Focal ARDS prone position will be promote early, with low PEEP and moderate Vt. Receives: Procedure: Mechanical ventilation |
| non focal ARDS | Other | In non-Focal ARDS, Recruitment maneuvers, high PEEP and low V twill be used Receives: Procedure: Mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
Measured: at day 90
Secondary outcomes (2)
sRAGE & esRAGE plasmatic concentrations
Measured: at Day 0 Day 1 Day 2 Day 3 Day 4 Day 6 .
Quality of life
Measured: at Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startJun 2014
- Primary completion12 Jun 2017
- Study completion2 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ARDSStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- AZUREA group
- Responsible party
- Sponsor
- Investigators
- Jean-Michel CONSTANTIN, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149589
- Sponsor's protocol ID
- CHU-0192
- Other IDs
- 2013-A01756-39
- Status last verified
- Apr 2026
- First submitted
- 26 May 2014
- Last updated
- 21 Apr 2026
- Results posted
- No
Publications
Constantin JM, Jabaudon M, Lefrant JY, Jaber S, Quenot JP, Langeron O, Ferrandiere M, Grelon F, Seguin P, Ichai C, Veber B, Souweine B, Uberti T, Lasocki S, Legay F, Leone M, Eisenmann N, Dahyot-Fizelier C, Dupont H, Asehnoune K, Sossou A, Chanques G, Muller L, Bazin JE, Monsel A, Borao L, Garcier JM, Rouby JJ, Pereira B, Futier E; AZUREA Network. Personalised mechanical ventilation tailored to lung morphology versus low positive end-expiratory pressure for patients with acute respiratory distress syndrome in France (the LIVE study): a multicentre, single-blind, randomised controlled trial. Lancet Respir Med. 2019 Oct;7(10):870-880. doi: 10.1016/S2213-2600(19)30138-9. Epub 2019 Aug 6.
PubMed 31399381Blanchard F, Godet T, Pons S, Kapandji N, Jabaudon M, Degos V, Borao L, Bougle A, Monsel A, Futier E, Constantin JM, James A. One-year patient outcomes based on lung morphology in acute respiratory distress syndrome: secondary analysis of LIVE trial. Crit Care. 2022 Jun 4;26(1):159. doi: 10.1186/s13054-022-04036-7.
PubMed 35659328Jabaudon M, Godet T, Futier E, Bazin JE, Sapin V, Roszyk L, Pereira B, Constantin JM; AZUREA group. Rationale, study design and analysis plan of the lung imaging morphology for ventilator settings in acute respiratory distress syndrome study (LIVE study): Study protocol for a randomised controlled trial. Anaesth Crit Care Pain Med. 2017 Oct;36(5):301-306. doi: 10.1016/j.accpm.2017.02.006. Epub 2017 Mar 18.
PubMed 28323236
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Imaging for Ventilatory Setting in ARDS
- ClinicalTrials.gov ID
- NCT02149589
- Acronym / sponsor ID
- CHU-0192
- Conditions
- ARDS
- Keywords
- ARDS, PEEP, Recruitment manoeuvres, Lung Morphology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- AZUREA group
- Study start
- Jun 2014 (actual)
- Primary completion
- 12 Jun 2017 (actual)
- Study completion
- 2 Feb 2018 (actual)
- First posted
- 29 May 2014 (estimated)
- 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.
To compare in ARDS patients 2 ventilatory Strategies : One based on Lung Morphology (Focal versus non-Focal ARDS) versus ARDS networks Guidelines (PEEP based on FiO2). In Focal ARDS prone position will be promote early, with low PEEP and moderate Vt. In non-Focal ARDS, Recruitment maneuvers, high PEEP and low V twill be used.
The investigators made the hypothesis that ventilation according to Lung morphology my decrease mortality at D90.
Detailed description
Early ARDS, less than 12 hours will be included. After Lung imaging, they will be randomized to a control group (PEEP/FiO2 according to ARDSnetwork tables) or an intervention arm. In this arm, mechanical ventilation will be set according to lung morphology. In patients with focal ARDS, prone position will be start quickly for at least 16 hours. After, A low PEEP and 8ml/kg of PBWwill be used. In non-focal ARDS, a recruitment maneuver followed by a high PEEP and a small tidal volume strategy will be used. In both arms, patients will be sedated and paralyzed during maximum 48 hours. As soon as PaO2/FiO2 > 200 mmHG, myorelaxant and sedation will be withdrawal. Pressure support ventilation will be used as soon as possible and weaning from ventilation will be checked everyday
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focal ARDS | Experimental | Procedure: Mechanical ventilationIn Focal ARDS prone position will be promote early, with low PEEP and moderate Vt. |
| non focal ARDS | Other | Procedure: Mechanical ventilationIn non-Focal ARDS, Recruitment maneuvers, high PEEP and low V twill be used |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Man or female older than 18 years
- ARDS since less than 12 hours
- PaO2 / FiO2 < 200 avec une PEEP ≥ 5 (Berlin Moderate or severe)
Key exclusion criteria (2 listed)
- brain injury with high ICP
- BMT Liver Cirrhosis Child C Pregnancy Burns Morbid obese patients (BMI > 40) Moribund
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 |
|---|---|---|
| Mechanical ventilation | Procedure or surgery | Focal ARDS, non focal ARDS |
Primary outcome
Mortality rate
Time frame: at day 90
2 secondary outcomes
sRAGE & esRAGE plasmatic concentrations
Time frame: at Day 0 Day 1 Day 2 Day 3 Day 4 Day 6 .
Quality of life
Time frame: at Day 365
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 21 Apr 2026.
- Results publication: PubMed 31399381Constantin JM, Jabaudon M, Lefrant JY, Jaber S, Quenot JP, Langeron O, Ferrandiere M, Grelon F, Seguin P, Ichai C, Veber B, Souweine B, Uberti T, Lasocki S, Legay F, Leone M, Eisenmann N, Dahyot-Fizelier C, Dupont H, Asehnoune K, Sossou A, Chanques G, Muller L, Bazin JE, Monsel A, Borao L, Garcier JM, Rouby JJ, Pereira B, Futier E; AZUREA Network. Personalised mechanical ventilation tailored to lung morphology versus low positive end-expiratory pressure for patients with acute respiratory distress syndrome in France (the LIVE study): a multicentre, single-blind, randomised controlled trial. Lancet Respir Med. 2019 Oct;7(10):870-880. doi: 10.1016/S2213-2600(19)30138-9. Epub 2019 Aug 6.
- Derived from this study: PubMed 35659328Blanchard F, Godet T, Pons S, Kapandji N, Jabaudon M, Degos V, Borao L, Bougle A, Monsel A, Futier E, Constantin JM, James A. One-year patient outcomes based on lung morphology in acute respiratory distress syndrome: secondary analysis of LIVE trial. Crit Care. 2022 Jun 4;26(1):159. doi: 10.1186/s13054-022-04036-7.
- Derived from this study: PubMed 28323236Jabaudon M, Godet T, Futier E, Bazin JE, Sapin V, Roszyk L, Pereira B, Constantin JM; AZUREA group. Rationale, study design and analysis plan of the lung imaging morphology for ventilator settings in acute respiratory distress syndrome study (LIVE study): Study protocol for a randomised controlled trial. Anaesth Crit Care Pain Med. 2017 Oct;36(5):301-306. doi: 10.1016/j.accpm.2017.02.006. Epub 2017 Mar 18.
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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.
Jean-Michel CONSTANTIN principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical ventilation in people with ARDS, run by University Hospital, Clermont-Ferrand 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 3 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 21 Apr 2026. 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?
Mortality rate (time frame: at day 90). 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 NCT02149589, which also lists 3 linked publications.
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 21 Apr 2026.