Evaluating PrismaLung Device for Removing Carbon Dioxide in Critically Ill Adults on Mechanical Ventilation in China

What this Trial Is About

Researchers are evaluating the efficacy and safety of the PrismaLung device for extracorporeal carbon dioxide removal ECCO2R in critically ill patients who require invasive mechanical ventilation IMV. This prospective, open-label, randomized controlled study compares the combination of IMV with ECCO2R using PrismaLung to IMV alone. The study aims to better manage carbon dioxide levels in patients with conditions like acute respiratory distress syndrome and acute kidney injury. Participants will be randomly assigned to one of two groups one group will receive IMV combined with ECCO2R using the PrismaLung device, while the control group will receive IMV alone. The PrismaLung treatment is planned to last up to 7 days, but investigators may stop the treatment earlier if ECCO2R is no longer needed. During ECCO2R, patients will receive systemic anticoagulation with heparin. Continuous renal replacement therapy may also be given alongside if necessary, based on the investigators judgment. Throughout the study, researchers will monitor carbon dioxide levels and other blood gas and oxygenation indexes at multiple time points, from 2 hours after treatment up to 7 days. They will also track ventilatory parameters, ventilator-free days, length of ICU stay, 28-day mortality, and quality of life after regaining consciousness and at 28 days. The primary outcome is the percent decrease in partial pressure of carbon dioxide PaCO2 from baseline after 2 hours of treatment. Participants will be closely observed during the study period, which starts December 2025 and ends August 2026.

A Study of the Efficacy and Safety of Extracorporeal Carbon Dioxide Removal Using PrismaLung+