Ultraprotective Lung Ventilation With Respiratory Extracorporeal Life Support for ARDS

Starting soon · Not applicable

Conditions studied: Acute Respiratory Distress Syndrome (ARDS)

In brief

Acute respiratory distress syndrome (ARDS) accounts for approximately 10% of all ICU admissions and 23% of patients requiring mechanical ventilation (MV). Despite advances in care, hospital mortality remains high, ranging from 34% in mild cases to 46% in severe ARDS. Positive-pressure MV remains the cornerstone of ARDS management. However, when excessive stress and strain are applied to the lung parenchyma, it can exacerbate lung injury, leading to ventilator-induced lung injury (VILI). VILI substantially contributes to morbidity and mortality in ARDS. Strategies that reduce tidal volume (Vt), driving pressure (ΔP, defined as plateau pressure minus PEEP), and respiratory rate (RR) can lower the mechanical power (PowerRS), i.e., the energy delivered to the lungs by the ventilator. This reduction in pulmonary stress and strain may lessen VILI and potentially improve survival. Nonetheless, reducing Vt to \<6 ml/kg in order to achieve plateau pressures \<23-25 cm H₂O, driving pressures \<9-11 cm H₂O, and RR \<15-20/min can result in severe hypercapnia. This, in turn, may increase intracranial pressure, promote pulmonary hypertension, impair myocardial contractility, reduce renal perfusion, and trigger endogenous catecholamine release. Thus, such "ultraprotective" MV strategies are not feasible for most ARDS patients managed with conventional ventilation. The neutral findings of the REST trial further suggested that low-flow extracorporeal CO₂ removal (ECCO₂R) devices may provide insufficient CO₂ clearance to enable ultraprotective ventilation while adequately controlling respiratory acidosis. Moreover, since partial lung derecruitment may occur with substantial Vt reduction, extracorporeal membrane oxygenation (ECMO) may be necessary, particularly in patients with PaO₂/FiO₂ \<120-130 at the time of Vt reduction. Therefore, respiratory extracorporeal life support (ECLS)-ranging from high-flow ECCO₂R to mid-flow venovenous ECMO (VV-ECMO)-can be employed in this setting. These modalities facilitate further reductions in ventilatory intensity while ensuring adequate oxygenation and CO₂ removal.

Key facts

Study ID: NCT07516665
Run by: Assistance Publique - Hôpitaux de Paris
People needed: 290
Starts: 2026-05-11
Expected to finish: 2028-08-01
Last updated by the study team: 2026-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Intubation and Invasive mechanical ventilation ≤ 7 days
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
One of the following criteria (with Vt set at 6 mL/kg PBW):
DeltaP ≥15 cm H2O OR
Ventilatory ratio ≥2.2
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.
Social security registration (AME excluded)

You may not qualify if…

Age <18 years
Pregnancy or breastfeeding
Catheter access to femoral vein or jugular vein impossible
Expected duration of mechanical ventilation < 48 hours
Chronic restrictive or obstructive (COPD) respiratory insufficiency with home ventilation or oxygen therapy
Currently receiving ECLS therapy
Severe cardiac failure or ongoing acute coronary syndrome
Heparin-induced thrombocytopenia
Severe underlying pre-existing condition with expected six-month mortality >50%
Contraindication for systemic anticoagulation (including platelet count <50G/L)
Patient moribund, decision to limit therapeutic interventions
Acute brain injury or irreversible neurological pathology
Bone marrow transplantation within the last 1 year
Actual body weight exceeding 1 kg per centimeter of height
Prior enrolment in the trial

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.