Ultra-Protective Lung Ventilation With Extracorporeal CO2 Removal for Moderate ARDS

NCT04903262 · tracked via the Priya Life Science Italy tracker

Sponsor

University of Bologna

Phase

Not applicable

Started

2024-12-01

Last updated

2025-04-02

Condition(s) studied

Acute Respiratory Distress Syndrome

Investigational drug(s) / intervention(s)

Ultraprotective ventilation with Extracorporeal CO2 removalConventional protective ventilation

Ultraprotective ventilation with Extracorporeal CO2 removal: HLS5.0 Cardiohelp® (Getinge Cardiopulmonary Care, Rastatt, Germany): 1.3 m² polymethylpentene hollow fiber membrane oxygenator. The extracorporeal blood flow is in the range of 1000 to 1500 mL/min. Sweep gas (air or oxygen) is drawn through the hollow fibers by a vacuum pump, creating a diffusion gradient for gas exchange across the membrane.

Conventional protective ventilation: Conventional lung protective mechanical ventilation, as described in the arm description ("standardized ventilation")

Study summary

Acute respiratory distress syndrome (ARDS) accounts for 10% of all ICU admissions and for 23% of patients requiring mechanical ventilation (MV). Its hospital mortality remains high, ranging from 34% in mild forms up to 46% in severe cases. Positive pressure MV remains the cornerstone of management, but at the same time it can contribute to worsening and maintenance of the lung injury when excessive stress and strain is applied to the lung parenchima (so-called ventilator-induced lung injury, VILI). VILI significantly contributes to the morbidity and mortality of ARDS patients, and it has been clearly demonstrated that protective (low-volume, low-pressure) MV settings are associated with a significant survival benefit. Unfortunately, in a certain proportion of ARDS cases, it is difficult to preserve acceptable gas exchange while maintaining protective ventilation settings, due to a high ventilatory load. In these cases, extracorporeal CO2 removal (ECCO2R) can be applied to grant the application of protective or even ultra-protective mechanical ventilation settings.

The main outcome of this multicenter, prospective, randomized, comparative open trial is to determine whether early ECCO2R allowing ultraprotective mechanical ventilation improves the outcomes of patients with moderate ARDS.

Eligibility

Sex

ALL

Min age

18 Years

Max age

100 Years

Healthy volunteers

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

Primary outcome measure(s)

Number of ventilator-free days (VFDs) at 28 days after randomization. — 28 days
VFD to-day 28 is defined as the number of days of unassisted breathing to day 28 after randomization, assuming a patient survives for at least two consecutive calendar days after initiating unassisted breathing and remains free of assisted breathing.

Trial sites (1)

Facility	City	Region	Status
IRCCS AOUBO Policlinico di Sant'Orsola	Bologna	Italy	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04903262 on ClinicalTrials.gov ↗ ← All trials in Italy