A Study of the Efficacy and Safety of Extracorporeal Carbon Dioxide Removal Using PrismaLung+
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVantive Health LLC
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- PrismaLung+
- Invasive Mechanical Ventilation
Treatment groups
99 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov