New lung-saving strategy aims to cut deadly ARDS complications
NCT ID NCT07516665
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new way to use breathing machines for people with severe lung failure (ARDS). The goal is to reduce lung damage by using very gentle breaths and adding a machine that helps remove carbon dioxide from the blood. About 290 adults on breathing machines for less than a week will be enrolled. The main outcome is survival and fewer days on the ventilator at day 30.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 290 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Intubation and Invasive mechanical ventilation ≤ 7 days 2. Presence of all of the following conditions for ≤48 hours: * 80 ≤ PaO2/FiO2 ≤300 with PEEP \>5 cmH2O * Bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules * Respiratory failure not fully explained by cardiac failure or fluid overload 3. One of the following criteria (with Vt set at 6 mL/kg PBW): * DeltaP ≥15 cm H2O OR * Ventilatory ratio ≥2.2 4. Signed Informed consent from a close relative or surrogate or a family member. 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/ger 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. 5. Social security registration (AME excluded) Exclusion Criteria: 1. Age \<18 years 2. Pregnancy or breastfeeding 3. Catheter access to femoral vein or jugular vein impossible 4. Expected duration of mechanical ventilation \< 48 hours 5. Chronic restrictive or obstructive (COPD) respiratory insufficiency with home ventilation or oxygen therapy 6. Currently receiving ECLS therapy 7. Severe cardiac failure or ongoing acute coronary syndrome 8. Heparin-induced thrombocytopenia 9. Severe underlying pre-existing condition with expected six-month mortality \>50% 10. Contraindication for systemic anticoagulation (including platelet count \<50G/L) 11. Patient moribund, decision to limit therapeutic interventions 12. Acute brain injury or irreversible neurological pathology 13. Bone marrow transplantation within the last 1 year 14. Actual body weight exceeding 1 kg per centimeter of height 15. Prior enrolment in the trial
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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