Acute Respiratory Distress SyndromePhase 3CALMDOWNNCT06814340
"Continuous Positive Airway Pressure on Venovenous extracorporeaL Membrane Oxygenation for Acute respIratory Distress syndrOme"
A Phase 3 study testing ECMO + near apneic ventilation and ECMO + ultra-protective lung ventilation in people with Acute Respiratory Distress Syndrome and Extracorporeal Membrane Oxygenation Complication, run by Assistance Publique - Hôpitaux de Paris at 11 sites in France.
Trial summary
The CALMDOWN trial is a prospective, open-label, multicenter, comparative, controlled trial randomizing patients who received near apneic ventilation vs usual care on ECMO (ultra-protective lung ventilation). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation Complication
- What is being tested?
- ECMO + near apneic ventilation and ECMO + ultra-protective lung ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 11 sitesFrance
- Study dates
- 6 May 2025to 6 May 2030
- Phase
- Phase 3
- 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
- Severe acute respiratory distress syndrome refractory to conventional therapy placed on VV-ECMO support in the 48 hours (maximum tolerance : +2h) preceding inclusion.
- Obtain informed consent from a close relative or surrogate. According to the specifications of emergency inclusion, randomization without the close relative/surrogate consent could be performed if the patient is unable to give his/her consent and when the close relative/surrogate/family member are absent. Close relative/surrogate/family member consent will be asked as soon as possible after randomization. The patient will be asked as soon as possible to give his/her consent for the continuation of the trial when his/her condition will allow.
- French Social security registration (except AME)
Who cannot join
- Age < 18
- Pregnancy or breastfeeding
- Initiation of VV-ECMO > 48 h (maximum tolerance : +2h)
- Cardiac arrest with cumulated no flow time \&gt;10 minutes before ECMO (within 48 hours prior to inclusion)
- Irreversible neurological pathology
- End-stage chronic lung disease
Show all 14Show fewer
- Contraindications for high PEEP level: untreated pneumothorax, barotrauma
- Irreversible ARDS with no hope for lung function recovery
- Patient moribund on the day of randomization, SAPS II \&gt;90
- Liver cirrhosis (Child B or C)
- Lung transplantation
- Burns on more than 20 % of the body surface
- Participation in another interventional study with a similar primary endpoint (mortality, lung transplantation, or duration of ECMO) or being in the exclusion period at the end of a previous study
- Individuals under guardianship, or permanently legally incompetent adults
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites, 11 recruiting
- Recruiting
Avicenne Hospital
Bobigny
Johanna OZIEL, 01 48 95 52 41, johanna.oziel@aphp.fr
- Recruiting
Haut Levèque Hospital - CHU Bordeaux
Bordeaux
Benjamin REPUSSEAU, Benjamin.Repusseau@chu-bordeaux.fr
- Recruiting
Henri Mondor Hospital
Créteil
Armand MEKONTSO-DESSAP, 01 45 17 85 11, armand.dessap@aphp.fr
- Recruiting
Croix-Rousse Hospital - HCL
Lyon
Jean-Christophe RICHARD, +33 4 72 04 17 62, j-christophe.richard@chu-lyon.fr
- Recruiting
North Hospital - APHM
Marseille
Christophe GUERVILLY, +33 4 91 96 58 42, christophe.guervilly@ap-hm.fr
- Recruiting
Mercy Hospital - CHR Metz
Metz
Benjamin PEQUIGNOT, benjamin.pequignot@chr-metz-thionville.fr
- Recruiting
Brabois Hospital - CHRU Nancy
Nancy
Matthieu KOSZUSTKI, +33 3 83 15 30 17, m.koszutski@chru-nancy.fr
- Recruiting
CHU Orléans
Orléans
François BARBIER, +33 2 38 22 99 39, francois.barbier@chu-orleans.fr
- Recruiting
Pitié-Salpêtrière Hospital
Paris
Matthieu SCHMIDT, 01 42 16 29 37, matthieu.schmidt@aphp.fr
- Recruiting
Pontchaillou Hospital - CHU Rennes
Rennes
Arnaud GACOUIN, +33 2 99 28 97 31, arnaud.gacouin@chu-rennes.fr
- Recruiting
CHU Tours
Tours
Emmanuelle MERCIER, +33 2 47 47 38 55, emmanuelle.mercier@univ-tours.fr
About this study
Official title: "Continuous Positive Airway Pressure on Venovenous extracorporeaL Membrane Oxygenation for Acute respIratory Distress syndrOme" - CALMDOWN
The CALMDOWN trial is a prospective, open-label, multicenter, comparative, controlled trial randomizing patients who received near apneic ventilation vs usual care on ECMO (ultra-protective lung ventilation).
The study goal is to investigate the benefit of early apneic ventilation in the most severe forms of acute respiratory distress syndrome (ARDS) rescued by ECMO.
Indeed, our hypothesis is that that early (near) apneic ventilation on venovenous ECMO for severe ARDS can enhance ventilator injury prevention and therefore reduce ECMO duration and mortality at Day 60.
- Being tested
- ECMO + near apneic ventilation, ECMO + ultra-protective lung ventilation
- Keywords
- ECMO, ARDS, CPAP
- 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.
ECMO + near apneic ventilationDevice
Near apneic ventilation will be use during the first 3 days of ECMO. Patients will be ventilated in BIPAP/APRV or pressure-controlled ventilation. PEEP will be set to maintain the same mean airway pressure obtained during the standardized ventilation period pre-randomization to prevent lung derecruitment (PEEP ≥15cmH2O). If BIPAP/APRV is used, an RR of 2-4/min will be set with high pressure set at 30cmH20 for 3 sec. If pressure-controlled ventilation is selected, a respiratory rate of two sigh breaths/min with 30 cmH2O plateau pressure will be applied. Each sigh breath will be of three seconds duration.
Neuromuscular blockade and sedation could be used at the discretion of the attending physician. After 3 days on ECMO, apneic ventilation could be pursued (at the physician's discretion). If not, ultra-protective lung ventilation will be applied (i.e standard of care). Prone positioning on ECMO will be left to the physicians' discretion.
ECMO + ultra-protective lung ventilationDevice
Ultra-protective lung ventilation will be used up to the ECMO weaning. This group will receive ultra-protective lung ventilation with BIPAP/APRV or VCV mode setting a PEEP >10 cmH2O, ΔP 14-15 cmH2O, RR 15-20/min, Vt 3-4ml/kg and lowest FiO2 to maintain SpO2>92%.
The use of prone positioning during ECMO will be left at the physician's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group : near apneic ventilation | Experimental | Patients will received near apneic ventilation during the first 3 days of ECMO. Receives: Device: ECMO + near apneic ventilation |
| Standard of care : ultra-protective lung ventilation | Active comparator | Patients will receive ultra-protective lung ventilation as it uses on usual care on ECMO. Receives: Device: ECMO + ultra-protective lung ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the application of early apneic ventilation on four components : mortality status at D60, need for lung transplantation at D60, persisting ECMO at D60, number of days alive between randomization and day 60 without ECMO
These components will be summarized in a composite, hierarchical outcome. Each patient will be compared with every other patient in the study and assigned a score (tie: 0, win: +1, loss: -1) for each pairwise comparison based on whom fared better. If one patient survived without lung transplantation or ECMO still ongoing at day 60 and the other did not, scores of +1 and -1 will be assigned, respectively. If both patients in the pairwise comparison survived without lung transplant or ECMO still ongoing at day 60, the assigned score will depend on which patient had more days free from ECMO: the patient with more days off ECMO will receive a score of +1, while the patient with fewer days will receive a score of -1. If both patients survived and had the same number of days off ECMO, or if both patients died or had a lung transplant, they will be both assigned a score of 0 for that pairwise comparison.
Measured: Day 0 to Day 60
Secondary outcomes (39)
Mortality
Efficacy of early apneic ventilation during VV-ECMO on mortality is defined as overall survival between inclusion and D60
Measured: From Day 1 to Day 60
Mortality
Efficacy of early apneic ventilation during VV-ECMO on mortality is defined as overall survival between inclusion and D90
Measured: From Day 1 to Day 90
Need for lung transplant
Efficacy of early apneic ventilation during VV-ECMO on the need for lung transplant is defined as lung transplant between inclusion and D60
Measured: From Day 1 to Day 60
Need for lung transplant
Efficacy of early apneic ventilation during VV-ECMO on the need for a lung transplant is defined as lung transplant between inclusion and D90
Measured: From Day 1 to Day 90
Duration of ECMO support
Defined as total duration with ECMO support between inclusion and D60
Measured: From Day 1 to Day 60
Duration of ECMO support
Defined as total duration with ECMO support between inclusion and D90
Measured: From Day 1 to Day 90
Duration of invasive mechanical ventilation
Defined as total duration of invasive mechanical ventilation between inclusion and D60
Measured: From Day 1 to Day 60
Duration of invasive mechanical ventilation
Defined as total duration of invasive mechanical ventilation between inclusion and D90
Measured: From Day 1 to Day 90
Duration of Intensive Care Unit
Defined as total duration spent in intensive care unit between inclusion and D60
Measured: From Day 1 to Day 60
Duration of Intensive Care Unit
Defined as total duration spent in intensive care unit between inclusion and D90
Measured: From Day 1 to Day 90
Hospital length of stay
Defined as total duration spent at the hospital between inclusion and D60
Measured: From Day 1 to Day 60
Hospital length of stay
Defined as total duration spent at the hospital between inclusion and D90
Measured: From Day 1 to Day 90
ECMO free days
Efficacy of early apneic ventilation during VV-ECMO on ECMO-free days is defined as the number of ECMO free-days between inclusion and D60
Measured: From Day 1 to Day 60
ECMO free days
Efficacy of early apneic ventilation during VV-ECMO on ECMO-free days is defined as number of ECMO free-days between inclusion and D90
Measured: From Day 1 to Day 90
Invasive mechanical ventilation free days
Efficacy of early apneic ventilation during VV-ECMO on invasive mecanical ventilation-free days between inclusion and D60
Measured: From Day 1 to Day 60
Invasive mechanical ventilation free days
Efficacy of early apneic ventilation during VV-ECMO on invasive mecanical ventilation-free days between inclusion and D90
Measured: From Day 1 to Day 90
Renal replacement therapy-free days
Efficacy of early apneic ventilation during VV-ECMO on renal function is defined as number of renal replacement therapy-free days between inclusion and D60
Measured: From Day 1 to Day 60
Renal replacement therapy-free days
Efficacy of early apneic ventilation during VV-ECMO on renal function is defined as renal replacement therapy-free days between inclusion and D90
Measured: From Day 1 to Day 90
Continuous neuromuscular blockade-free days
Efficacy of early apneic ventilation during VV-ECMO on continuous neuromuscular blockade is defined as number of continuous neuromuscular blockade-free days between inclusion and D60
Measured: From Day 1 to Day 60
Continuous neuromuscular blockade-free days
Efficacy of early apneic ventilation during VV-ECMO on continuous neuromuscular blockade is defined as number of continuous neuromuscular blockade-free days between inclusion and D90
Measured: From Day 1 to Day 90
Intervention side effects (ventilation-associated pneumonia)
Defined as the incidence of ventilation-associated pneumonia between inclusion and D14
Measured: From Day 1 to Day D14
Intervention side effets (need for inotropes or vasopressors)
Defined as the incidence of need for inotropes or vasopressors within 14 days on ECMO
Measured: From Day 1 to Day 14
Intervention side effets (intravenous sedation consumption)
Defined as the incidence of intravenous sedation consumption during the first 14 days on ECMO
Measured: From Day 1 to Day 14
Acute cor pulmonale
Defined as the incidence of acute cor pulmonale between inclusion and D60
Measured: From Day 1 to Day 60
Acute cor pulmonale
Defined as the incidence of acute cor pulmonale between inclusion and D90
Measured: From Day 1 to Day 90
Pneumothorax
Defined as the incidence of pneumothorax between inclusion and D60
Measured: From Day 1 to Day 60
Pneumothorax
Defined as the incidence of pneumothorax between inclusion and D90
Measured: From Day 1 to Day 90
Severe refractory hypoxemia on ECMO
Defined as the incidence of refractory severe hypoxemia between inclusion and D60
Measured: From Day 1 to Day 60
Severe refractory hypoxemia on ECMO
Defined as the incidence of refractory severe hypoxemia between inclusion and D90
Measured: From Day 1 to Day 90
Compliance of the respiratory system at D7
Effect of near apneic ventilation on the improvement of the compliance of the respiratory system (ml/cmH2O) at D7
Measured: From Day 1 to Day 7
Compliance of the respiratory system at D10
Effect of near apneic ventilation on the improvement of the compliance of the respiratory system (ml/cmH2O) at D10
Measured: From Day 1 to Day 10
Compliance of the respiratory system at D14
Effect of near apneic ventilation on the improvement of the compliance of the respiratory system (ml/cmH2O) at D14
Measured: From Day 1 to Day 14
Compliance of the respiratory system at D28
Effect of near apneic ventilation on the improvement of the compliance of the respiratory system (ml/cmH2O) at D28
Measured: From Day 1 to Day 28
Compliance of the respiratory system at D60
Effect of near apneic ventilation on the improvement of the compliance of the respiratory system (ml/cmH2O) at D60
Measured: From Day 1 to Day 60
Right ventricular function at D3
Effect of near apneic ventilation on right ventricular function evaluated by echocardiograohy (RV/LV diameter ratio) at D3 on ECMO following randomization
Measured: From Day 1 to Day 3
Right ventricular function at D7
Effect of near apneic ventilation on right ventricular function evaluated by echocardiograohy (RV/LV diameter ratio) at D7 on ECMO following randomization
Measured: From Day 1 to Day 7
Right ventricular function at D14
Effect of near apneic ventilation on right ventricular function evaluated by echocardiograohy (RV/LV diameter ratio) at D14 on ECMO following randomization
Measured: From Day 1 to Day 14
Right ventricular function at D28
Effect of near apneic ventilation on right ventricular function evaluated by echocardiograohy (RV/LV diameter ratio) at D28 on ECMO following randomization
Measured: From Day 1 to Day 28
Right ventricular function at D60
Effect of near apneic ventilation on right ventricular function evaluated by echocardiograohy (RV/LV diameter ratio) at D60 on ECMO following randomization
Measured: From Day 1 to Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start6 May 2025
- Primary completion6 May 2029 (estimated)
- Study completion6 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814340
- Sponsor's protocol ID
- APHP230850
- Acronym
- CALMDOWN
- Status last verified
- Apr 2026
- First submitted
- 22 Jan 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Continuous Positive Airway Pressure on Venovenous extracorporeaL Membrane Oxygenation for Acute respIratory Distress syndrOme" - CALMDOWN
- ClinicalTrials.gov ID
- NCT06814340
- Acronym / sponsor ID
- CALMDOWN / APHP230850
- Keywords
- ECMO, ARDS, CPAP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 6 May 2025 (actual)
- Primary completion
- 6 May 2029 (estimated)
- Study completion
- 6 May 2030 (estimated)
- First posted
- 7 Feb 2025 (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.
The CALMDOWN trial is a prospective, open-label, multicenter, comparative, controlled trial randomizing patients who received near apneic ventilation vs usual care on ECMO (ultra-protective lung ventilation).
The study goal is to investigate the benefit of early apneic ventilation in the most severe forms of acute respiratory distress syndrome (ARDS) rescued by ECMO.
Indeed, our hypothesis is that that early (near) apneic ventilation on venovenous ECMO for severe ARDS can enhance ventilator injury prevention and therefore reduce ECMO duration and mortality at Day 60.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group : near apneic ventilation | Experimental | Device: ECMO + near apneic ventilationPatients will received near apneic ventilation during the first 3 days of ECMO. |
| Standard of care : ultra-protective lung ventilation | Active comparator | Device: ECMO + ultra-protective lung ventilationPatients will receive ultra-protective lung ventilation as it uses on usual care on ECMO. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Severe acute respiratory distress syndrome refractory to conventional therapy placed on VV-ECMO support in the 48 hours (maximum tolerance : +2h) preceding inclusion.
- Obtain informed consent from a close relative or surrogate. According to the specifications of emergency inclusion, randomization without the close relative/surrogate consent could be performed if the patient is unable to give his/her consent and when the close relative/surrogate/family member are absent. Close relative/surrogate/family member consent will be asked as soon as possible after randomization. The patient will be asked as soon as possible to give his/her consent for the continuation of the trial when his/her condition will allow.
- French Social security registration (except AME)
Key exclusion criteria (14 listed)
- Age < 18
- Pregnancy or breastfeeding
- Initiation of VV-ECMO > 48 h (maximum tolerance : +2h)
- Cardiac arrest with cumulated no flow time \&gt;10 minutes before ECMO (within 48 hours prior to inclusion)
- Irreversible neurological pathology
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 |
|---|---|---|
| ECMO + near apneic ventilationNear apneic ventilation will be use during the first 3 days of ECMO. Patients will be ventilated in BIPAP/APRV or pressure-controlled ventilation. PEEP will be set to maintain the same mean airway pressure obtained during the standardized ventilation period pre-randomization to prevent lung derecruitment (PEEP ≥15cmH2O). If BIPAP/APRV is used, an RR of 2-4/min will be set with high pressure set at 30cmH20 for 3 sec. If pressure-controlled ventilation is selected, a respiratory rate of two sigh breaths/min with 30 cmH2O plateau pressure will be applied. Each sigh breath will be of three seconds duration. Neuromuscular blockade and sedation could be used at the discretion of the attending physician. After 3 days on ECMO, apneic ventilation could be pursued (at the physician's discretion). If not, ultra-protective lung ventilation will be applied (i.e standard of care). Prone positioning on ECMO will be left to the physicians' discretion. | Device | Intervention group : near apneic ventilation |
| ECMO + ultra-protective lung ventilationUltra-protective lung ventilation will be used up to the ECMO weaning. This group will receive ultra-protective lung ventilation with BIPAP/APRV or VCV mode setting a PEEP >10 cmH2O, ΔP 14-15 cmH2O, RR 15-20/min, Vt 3-4ml/kg and lowest FiO2 to maintain SpO2>92%. The use of prone positioning during ECMO will be left at the physician's discretion. | Device | Standard of care : ultra-protective lung ventilation |
Primary outcome
Efficacy of the application of early apneic ventilation on four components : mortality status at D60, need for lung transplantation at D60, persisting ECMO at D60, number of days alive between randomization and day 60 without ECMO
Time frame: Day 0 to Day 60
These components will be summarized in a composite, hierarchical outcome. Each patient will be compared with every other patient in the study and assigned a score (tie: 0, win: +1, loss: -1) for each pairwise comparison based on whom fared better. If one patient survived without lung transplantation or ECMO still ongoing at day 60 and the other did not, scores of +1 and -1 will be assigned, respectively. If both patients in the pairwise comparison survived without lung transplant or ECMO still ongoing at day 60, the assigned score will depend on which patient had more days free from ECMO: the patient with more days off ECMO will receive a score of +1, while the patient with fewer days will receive a score of -1. If both patients survived and had the same number of days off ECMO, or if both patients died or had a lung transplant, they will be both assigned a score of 0 for that pairwise comparison.
39 secondary outcomes
Mortality
Time frame: From Day 1 to Day 60
Mortality
Time frame: From Day 1 to Day 90
Need for lung transplant
Time frame: From Day 1 to Day 60
Need for lung transplant
Time frame: From Day 1 to Day 90
Duration of ECMO support
Time frame: From Day 1 to Day 60
Duration of ECMO support
Time frame: From Day 1 to Day 90
Duration of invasive mechanical ventilation
Time frame: From Day 1 to Day 60
Duration of invasive mechanical ventilation
Time frame: From Day 1 to Day 90
Duration of Intensive Care Unit
Time frame: From Day 1 to Day 60
Duration of Intensive Care Unit
Time frame: From Day 1 to Day 90
Hospital length of stay
Time frame: From Day 1 to Day 60
Hospital length of stay
Time frame: From Day 1 to Day 90
ECMO free days
Time frame: From Day 1 to Day 60
ECMO free days
Time frame: From Day 1 to Day 90
Invasive mechanical ventilation free days
Time frame: From Day 1 to Day 60
Invasive mechanical ventilation free days
Time frame: From Day 1 to Day 90
Renal replacement therapy-free days
Time frame: From Day 1 to Day 60
Renal replacement therapy-free days
Time frame: From Day 1 to Day 90
Continuous neuromuscular blockade-free days
Time frame: From Day 1 to Day 60
Continuous neuromuscular blockade-free days
Time frame: From Day 1 to Day 90
Intervention side effects (ventilation-associated pneumonia)
Time frame: From Day 1 to Day D14
Intervention side effets (need for inotropes or vasopressors)
Time frame: From Day 1 to Day 14
Intervention side effets (intravenous sedation consumption)
Time frame: From Day 1 to Day 14
Acute cor pulmonale
Time frame: From Day 1 to Day 60
Acute cor pulmonale
Time frame: From Day 1 to Day 90
Pneumothorax
Time frame: From Day 1 to Day 60
Pneumothorax
Time frame: From Day 1 to Day 90
Severe refractory hypoxemia on ECMO
Time frame: From Day 1 to Day 60
Severe refractory hypoxemia on ECMO
Time frame: From Day 1 to Day 90
Compliance of the respiratory system at D7
Time frame: From Day 1 to Day 7
Compliance of the respiratory system at D10
Time frame: From Day 1 to Day 10
Compliance of the respiratory system at D14
Time frame: From Day 1 to Day 14
Compliance of the respiratory system at D28
Time frame: From Day 1 to Day 28
Compliance of the respiratory system at D60
Time frame: From Day 1 to Day 60
Right ventricular function at D3
Time frame: From Day 1 to Day 3
Right ventricular function at D7
Time frame: From Day 1 to Day 7
Right ventricular function at D14
Time frame: From Day 1 to Day 14
Right ventricular function at D28
Time frame: From Day 1 to Day 28
Right ventricular function at D60
Time frame: From Day 1 to Day 60
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 13 Apr 2026.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ECMO + near apneic ventilation and ECMO + ultra-protective lung ventilation in people with Acute Respiratory Distress Syndrome and Extracorporeal Membrane Oxygenation Complication, run by Assistance Publique - Hôpitaux de Paris at 11 sites 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 14 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 13 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 11 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Matthieu SCHMIDT, MD (01 42 16 29 37, matthieu.schmidt@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the application of early apneic ventilation on four components : mortality status at D60, need for lung transplantation at D60, persisting ECMO at D60, number of days alive between randomization and day 60 without ECMO (time frame: Day 0 to Day 60). 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 13 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.