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

Vantive Health LLC

Status: Not yet enrolling

Conditions: Acute Kidney Injury; Acute Respiratory Distress Syndrome

Treatments: Other: Invasive Mechanical Ventilation; Device: PrismaLung+

Study type: Interventional

Funder types: Industry

Identifiers

NCT07326215

BXU614243

Details and patient eligibility

About

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.

Enrollment: 99 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

Patients receiving IMV combined with ECCO2R

Experimental group

Description:

Patients will receive IMV combined with ECCO2R using PrismaLung+.

Treatment:

Device: PrismaLung+

Patients receiving IMV alone

Active Comparator group

Treatment:

Other: Invasive Mechanical Ventilation