ARDS, HumanECMO-VILINCT03918603
Decrease of Lesions Induced by Mechanical Ventilation During ARDS
A study testing ventral décubitus in people with ARDS, Human, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Modification of mechanically ventilated lesions by an ultra-protective multimodal strategy compared to a protective strategy in patients with veno-venous ECMO for severe ARDS. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- ARDS, Human
- What is being tested?
- ventral décubitus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jul 2019to 23 Jun 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- severe ARDS with a PaO2 / FiO2 ratio ≤ 70 mmHg (for at least 2h) measured at PEEP> 10 cmH2O and FiO2 = 1
- OR a severe ARDS with a PaO2 / FiO2> 70 ratio but <100 mmHg with a plateau pressure> 35 cmH2O and a pH <7.20
Who cannot join
- Patients with associated hemodynamic failure requiring veno-arterial ECMO
- Impossibility of setting up or contraindication to the placement of an esophageal tube
- Impossibility of realization of ventral decubitus
- Patient to receive corticosteroids during the first 48 hours following venous venous ECMO.
- Patients assisted by veno-venous ECMO for more than 24 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of Mechanical Ventilation-induced Lesions During ARDS With Multimodal Ultra-protective Ventilation in Combination With ECMO
Modification of mechanically ventilated lesions by an ultra-protective multimodal strategy compared to a protective strategy in patients with veno-venous ECMO for severe ARDS.
Read the detailed description
the hypothesis is that ECMO, in addition to improving gas exchange, should limit the deleterious effects of mechanical ventilation (mechanical ventilation-induced lesions, VILI) by drastically reducing minute ventilation (volume reduction). current, Vt, reduction of respiratory rate, reduction of mechanical power, reduction of motor pressure or driving pressure), adapting the level of PEEP from the data collected by monitoring oesophageal pressure and systematically performing positioning sessions in the prone position. This ultra-protective strategy could thus promote the restoration of the integrity of the alveolo-capillary membrane and thus facilitate the healing of patients. In order to verify this concept and, if necessary, to propose a study whose objectives would be more clinical (mortality, ventilator-free days), we propose to carry out a study aimed at showing that this ultra-protective multimodal strategy reduces the lesions induced by mechanical ventilation compared to usual protective ventilatory management during the ECMO as proposed in the EOLIA study.
- Conditions
- ARDS, Human
- Being tested
- ventral décubitus
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ventral décubitusOther
Patient will have one session at least more than 12 hours between inclusion and H48 of ventral décubitus
| Study group | Role | What they receive |
|---|---|---|
| ultra-protective multimodal ventilation group | Experimental | Patient will be diposed on ventral decubitus: one session at least more than 12 hours between inclusion and H48 Receives: Other: ventral décubitus |
| protective ventilation group | No intervention | Patient will received usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammation of biotrauma
Interleukine dosage in pg/mL
Measured: 36months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start3 Jul 2019
- Primary completion23 Apr 2021
- Study completion23 Jun 2021
Why it stopped: mid-term analysis
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 ARDS, HumanStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie GARRIDO, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918603
- Sponsor's protocol ID
- 2018-45
- Other IDs
- 2018-A02297-48
- Acronym
- ECMO-VILI
- Status last verified
- Oct 2026
- First submitted
- 12 Apr 2019
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guervilly C, Fournier T, Chommeloux J, Arnaud L, Pinglis C, Baumstarck K, Boucekine M, Valera S, Sanz C, Adda M, Bobot M, Daviet F, Gragueb-Chatti I, Forel JM, Roch A, Hraiech S, Dignat-George F, Schmidt M, Lacroix R, Papazian L. Ultra-lung-protective ventilation and biotrauma in severe ARDS patients on veno-venous extracorporeal membrane oxygenation: a randomized controlled study. Crit Care. 2022 Dec 12;26(1):383. doi: 10.1186/s13054-022-04272-x.
PubMed 36510324
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Mechanical Ventilation-induced Lesions During ARDS With Multimodal Ultra-protective Ventilation in Combination With ECMO
- ClinicalTrials.gov ID
- NCT03918603
- Acronym / sponsor ID
- ECMO-VILI / 2018-45
- Conditions
- ARDS, Human
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: mid-term analysis
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 23 Apr 2021 (actual)
- Study completion
- 23 Jun 2021 (actual)
- First posted
- 17 Apr 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.
Modification of mechanically ventilated lesions by an ultra-protective multimodal strategy compared to a protective strategy in patients with veno-venous ECMO for severe ARDS.
Detailed description
the hypothesis is that ECMO, in addition to improving gas exchange, should limit the deleterious effects of mechanical ventilation (mechanical ventilation-induced lesions, VILI) by drastically reducing minute ventilation (volume reduction). current, Vt, reduction of respiratory rate, reduction of mechanical power, reduction of motor pressure or driving pressure), adapting the level of PEEP from the data collected by monitoring oesophageal pressure and systematically performing positioning sessions in the prone position. This ultra-protective strategy could thus promote the restoration of the integrity of the alveolo-capillary membrane and thus facilitate the healing of patients. In order to verify this concept and, if necessary, to propose a study whose objectives would be more clinical (mortality, ventilator-free days), we propose to carry out a study aimed at showing that this ultra-protective multimodal strategy reduces the lesions induced by mechanical ventilation compared to usual protective ventilatory management during the ECMO as proposed in the EOLIA study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultra-protective multimodal ventilation group | Experimental | Other: ventral décubitusPatient will be diposed on ventral decubitus: one session at least more than 12 hours between inclusion and H48 |
| protective ventilation group | No intervention | –Patient will received usual care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- severe ARDS with a PaO2 / FiO2 ratio ≤ 70 mmHg (for at least 2h) measured at PEEP> 10 cmH2O and FiO2 = 1
- OR a severe ARDS with a PaO2 / FiO2> 70 ratio but <100 mmHg with a plateau pressure> 35 cmH2O and a pH <7.20
Key exclusion criteria (5 listed)
- Patients with associated hemodynamic failure requiring veno-arterial ECMO
- Impossibility of setting up or contraindication to the placement of an esophageal tube
- Impossibility of realization of ventral decubitus
- Patient to receive corticosteroids during the first 48 hours following venous venous ECMO.
- Patients assisted by veno-venous ECMO for more than 24 hours.
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 |
|---|---|---|
| ventral décubitusPatient will have one session at least more than 12 hours between inclusion and H48 of ventral décubitus | Other | ultra-protective multimodal ventilation group |
Primary outcome
inflammation of biotrauma
Time frame: 36months
Interleukine dosage in pg/mL
Results and safety
The study was stopped early (reason given: mid-term analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Results publication: PubMed 36510324Guervilly C, Fournier T, Chommeloux J, Arnaud L, Pinglis C, Baumstarck K, Boucekine M, Valera S, Sanz C, Adda M, Bobot M, Daviet F, Gragueb-Chatti I, Forel JM, Roch A, Hraiech S, Dignat-George F, Schmidt M, Lacroix R, Papazian L. Ultra-lung-protective ventilation and biotrauma in severe ARDS patients on veno-venous extracorporeal membrane oxygenation: a randomized controlled study. Crit Care. 2022 Dec 12;26(1):383. doi: 10.1186/s13054-022-04272-x.
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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.
Emilie GARRIDO study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ventral décubitus in people with ARDS, Human, run by Assistance Publique Hopitaux De Marseille 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 5 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: stopped early, as of the sponsor's last update on 15 Oct 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 was stopped early (reason given: mid-term analysis). Results are not available in the source record.
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?
inflammation of biotrauma (time frame: 36months). 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 NCT03918603, 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 15 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.