A Study of the Efficacy and Safety of Extracorporeal Carbon Dioxide Removal Using PrismaLung+ (NCT07326215) | Clinical Trial Compass
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A Study of the Efficacy and Safety of Extracorporeal Carbon Dioxide Removal Using PrismaLung+
China99 participantsStarted 2025-12-11
Plain-language summary
PrismaLung+ is a sterile, single-use medical device aimed at performing partial removal of carbon dioxide (CO2) from the patient's venous blood via diffusion through a membrane. The goal of this prospective, open label, randomized controlled study is to evaluate the efficacy and safety of PrismaLung+ on extracorporeal carbon dioxide removal (ECCO2R) in critically ill patients under invasive mechanical ventilation (IMV). Patients will be randomized to receive either IMV combined with ECCO2R (using PrismaLung+) in the study group or IMV alone in the control group, at a ratio of 2:1.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years old.
✓. Invasive mechanical ventilation patients with PaCO2 \> 50 mmHg and pH \< 7.4 under LPV strategy (RR \< 25/min, DP \< 15 cmH2O).
✓. Expected to be able to tolerate ECCO2R for a minimum of 2h.
✓. Patients signed a written informed consent; if the right to consent cannot be exercised due to loss of decision-making ability or impairment of consciousness, the legal representative or immediate family member must sign the informed consent document after fully understanding the research content.
Exclusion criteria
✕. Body weight \< 30 kg.
✕. Has a contraindication for systemic anticoagulation with heparin according to the Investigator.
✕. Patient unable to establish extracorporeal circulation access or has a high risk of establishing such access, as judged by the Investigator.
✕. Allergic to the investigational device/tubing, and/or to the CRRT filters/tubing if combined with CRRT treatment.
What they're measuring
1
The percent decrease of partial pressure of carbon dioxide (PaCO2) from baseline after 2h of treatment.