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Compares treatment options for ARDS (Acute Respiratory Distress Syndrome)
Official title Free for Weaning ECMO vs Respiratory Driven Study
ClinicalTrials.gov ID: NCT06876415
What this study is testing
- What it's testing
- In its most severe form, Acute Respiratory Distress Syndrome (ARDS) may require the use of veno-venous ECMO (vvECMO). While the criteria for vvECMO indication, ECMO settings, and ventilator management are relatively well-defined after the publication of the EOLIA trial and subsequent national or international guidelines, few studies have assessed the criteria and methods for weaning from vvECMO.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients aged 18 years or older Patient whose trusted person has given consent for participation in the study
- Patient on veno-venous ECMO with weaning criteria, including:
- Resolution of the cause of ARDS
- Absence of hemodynamic instability, defined as norepinephrine dose ≤ 0.5 μg/kg/min for at least 3 hours
- Use of a ventilatory mode that allows spontaneous ventilation (VS-AI, BiPAP, or APRV)
You likely can't join if
- Contraindication to the placement of an esophageal pressure balloon (e.g., esophageal varices, nasal trauma, uncontrolled coagulopathy, severe...
- Patient with treatment limitation at the time of inclusion,
- Patient in the time frame of exclusion from another research protocol at the time of consent signing,
- Vulnerable patients: minor, adult patient under guardianship or curatorship, patient deprived of liberty, pregnant or breastfeeding woman.
See the full eligibility criteria
- Adult patients aged 18 years or older Patient whose trusted person has given consent for participation in the study
- Patient on veno-venous ECMO with weaning criteria, including:
- Resolution of the cause of ARDS
- Absence of hemodynamic instability, defined as norepinephrine dose ≤ 0.5 μg/kg/min for at least 3 hours
- Use of a ventilatory mode that allows spontaneous ventilation (VS-AI, BiPAP, or APRV)
- Maximum inspiratory pressure ≤ 28 cm H2O, with a maximum driving pressure ≤ 15 cm H2O, enabling tidal volumes between 4 and 8 ml/kg of predicted body weight (PBW)
- ECMO membrane sweep flow ≤ 2 L/min
- Patient protected by social security
- Contraindication to the placement of an esophageal pressure balloon (e.g., esophageal varices, nasal trauma, uncontrolled coagulopathy, severe thrombocytopenia),
- Patient with treatment limitation at the time of inclusion,
- Patient in the time frame of exclusion from another research protocol at the time of consent signing,
- Vulnerable patients: minor, adult patient under guardianship or curatorship, patient deprived of liberty, pregnant or breastfeeding woman.
The study team makes the final eligibility decision.
Where it's taking place
- Lyon, France
- Marseille, France
- Nice, France
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lyon, France; Marseille, France; Nice, France; Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.