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

Recruiting N/A Interventional Study
Acute Respiratory Distress Syndrome Acute Kidney Injury
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
99 (estimated)
Sponsor
Vantive Health LLC · Industry
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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 mechan…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years old. 2. Invasive mechanical ventilation patients with PaCO2 \> 50 mmHg and pH \< 7.4 under LPV strategy (RR \< 25/min, DP \< 15 cmH2O). 3. Expected to be able to tolerate ECCO2R for a minimum of 2h. 4. Patients signed a written informed consent; if the right to…
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Global CORP Clinical Trials Disclosure

+1 2249484283

Global.CORP.ClinicalTrialsDisclosure@vantive.com

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