What is PrismaLung+ studying for critically ill patients?

PrismaLung+ is being studied to evaluate its ability to remove carbon dioxide from the blood in critically ill patients who need invasive mechanical ventilation. The trial aims to assess how well this device works and how safe it is compared to ventilation alone. This research is sponsored by Vantive Health LLC to improve care for patients with serious respiratory conditions.

Who may be eligible for this acute respiratory distress syndrome clinical trial?

Adults aged 18 years or older who are on invasive mechanical ventilation with high carbon dioxide levels and low blood pH may be eligible. Both males and females can participate, but patients must be able to tolerate extracorporeal carbon dioxide removal for at least 2 hours. People with contraindications to anticoagulation or certain medical risks cannot join. Please review eligibility criteria for more details.

Is there any cost to participate in this acute respiratory distress syndrome clinical trial?

Study-related care, including the use of the PrismaLung+ device and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation needs.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID07326215

A Study of the Efficacy and Safety of Extracorporeal Carbon Dioxide Removal Using PrismaLung in Chinese Critically Ill Patients a Prospective Randomized Controlled Clinical Trial

Led by Vantive Health LLC · Updated on 2026-02-17

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years old or older
Receiving invasive mechanical ventilation with PaCO2 greater than 50 mmHg and pH less than 7.4 under lung-protective ventilation strategy (respiratory rate less than 25/min, driving pressure less than 15 cmH2O)
Expected to tolerate extracorporeal carbon dioxide removal for at least 2 hours
Signed written informed consent or consent provided by legal representative or immediate family if patient lacks decision-making ability

You will not qualify if you...

Body weight less than 30 kilograms
Contraindication for systemic anticoagulation with heparin
Unable or high risk to establish extracorporeal circulation access
Allergy to PrismaLung+ device/tubing or CRRT filters/tubing if combined with CRRT
Expected need for extracorporeal membrane oxygenation within 24 hours after enrollment
Primary disease expected to worsen rapidly or require surgery within 24 hours after enrollment
Diagnosed brain dead or in vegetative state
Pregnant or breastfeeding
Participation in other device studies within 30 days before screening or during study, or recent clinical drug study
Considered unsuitable for participation by investigator

Research Team

Global CORP Clinical Trials Disclosure

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here