Ultra-protective lung ventilation with extracorporeal CO2 removal for ARDS

Strategy of Ultra-Protective Lung Ventilation With Extracorporeal CO2 Removal for New-Onset Moderate ARDS: A Prospective Multicenter Randomized Clinical Trial

This study is testing a new way of helping people with moderate Acute Respiratory Distress Syndrome (ARDS) breathe better while protecting their lungs from damage caused by ventilators.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 230 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: University of Bologna (other)
• Locations: 1 site (Bologna)
• Trial ID: NCT04903262 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of ultra-protective lung ventilation combined with extracorporeal CO2 removal in patients suffering from moderate Acute Respiratory Distress Syndrome (ARDS). The approach aims to minimize ventilator-induced lung injury (VILI) while ensuring adequate gas exchange in patients who are on invasive mechanical ventilation. By applying this innovative ventilation strategy, the study seeks to improve patient outcomes and reduce mortality associated with ARDS. The trial will include patients who meet specific criteria related to their respiratory condition and mechanical ventilation status.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who are on invasive mechanical ventilation for no more than 96 hours and meet specific clinical criteria for moderate ARDS.

Not a fit: Patients with severe COPD, chronic respiratory insufficiency requiring home ventilation, or those expected to need mechanical ventilation for less than 48 hours may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce mortality rates and improve recovery outcomes for patients with moderate ARDS.

How similar studies have performed: While the use of protective ventilation strategies has been established, the combination with extracorporeal CO2 removal is a novel approach that has not been extensively tested in this specific context.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years
* On invasive mechanical ventilation for ≤ 96 hours
* Presence of all of the following conditions for ≤ 24 hours: 100 \< PaO2/FiO2 ≤ 200 after 12 hours of "standardized ventilation" with PEEP ≥ 5; compliance of the respiratory system ≤ 0.5 ml/cmH2O per kg PBW; ventilatory ratio (VR) ≥ 1.5; bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules; respiratory failure not fully explained by cardiac failure or fluid overload

Exclusion Criteria:

* Pregnancy
* ARDS with PaO2/FiO2\<100 or PaO2/FiO2\>200 under standardized ventilation with PEEP ≥ 5 cmH2O
* Expected duration of mechanical ventilation \< 48 hours
* Severe COPD
* Chronic respiratory insufficiency with home ventilation or oxygen therapy
* Currently receiving ECMO therapy
* Acute brain injury
* Severe liver insufficiency (Child-Pugh scores \>7) or fulminant hepatic failure
* Heparin-induced thrombocytopenia
* Contraindication for systemic anticoagulation
* Platelet count \<50,000/mm3
* Prothrombin time-international normalized ratio (INR) \>1.5
* Patient moribund, decision to limit therapeutic interventions
* End-stage disease
* Unable to provide vascular access for ECCO2-R
* Acute coronary syndrome
* Actual body weight exceeding 1 kg per centimeter of height
* Burns \> 40% total body surface
* Bone marrow transplantation within the last 1 year

Where this trial is running

Bologna

• IRCCS AOUBO Policlinico di Sant'Orsola — Bologna, Italy (RECRUITING)

Study contacts

• Study coordinator: Tommaso Tonetti, M.D.

Conditions: Acute Respiratory Distress Syndrome