PrismaLung+ carbon dioxide removal for ventilated ICU patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

PrismaLung+ is a sterile, single-use device designed to remove carbon dioxide from venous blood by diffusion across a membrane. In this prospective, open-label, randomized controlled study, critically ill adults on invasive mechanical ventilation with elevated PaCO2 and acidemia will be randomized 2:1 to receive extracorporeal CO2 removal with PrismaLung+ plus standard ventilation or standard ventilation alone. The trial will track physiological CO2 removal, ventilator settings, and safety outcomes such as bleeding and access complications. The protocol requires patients to be able to tolerate at least 2 hours of ECCO2R and uses lung-protective ventilation strategies throughout.

Why it matters

Who can join: the full rules

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 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:

1. Body weight \< 30 kg.
2. Has a contraindication for systemic anticoagulation with heparin according to the Investigator.
3. Patient unable to establish extracorporeal circulation access or has a high risk of establishing such access, as judged by the Investigator.
4. Allergic to the investigational device/tubing, and/or to the CRRT filters/tubing if combined with CRRT treatment.
5. Expected to require extracorporeal membrane oxygenator (ECMO) treatment within 24h after enrollment.
6. Patient's primary disease is expected to worsen rapidly or require other surgical intervention within 24h after enrollment.
7. Diagnosed as brain dead or in a vegetative state.
8. Pregnant and/or breastfeeding.
9. Plans to participate in other device studies within 30 days before screening or during the study period or has completed any clinical drug study within 5 half lives of the investigational drug.
10. Patients is considered as unsuitable for participating in the study, as judged by the Investigator.

Where it's running

• China-Japan Friendship Hospital
  Beijing, Beijing Municipality, China Recruiting
• The University of Hong Kong-Shenzhen Hospital
  Shenzhen, Guangdong, China Recruiting
• The First Affiliated Hospital of Harbin Medical University
  Harbin, Heilongjiang, China Recruiting
• Zhongda Hospital Southeast University
  Nanjing, Jiangsu, China Recruiting
• The First Affiliated Hospital of Nanchang University
  Nanchang, Jiangxi, China Recruiting
• ZhongShan Hospital Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Global CORP Clinical Trials Disclosure
• Email: Global.CORP.ClinicalTrialsDisclosure@vantive.com
• Phone: +1 2249484283

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.