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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
PrismaLung+
DevicePrismaLung+ is a medical device that provides ECCO2R as a stand-alone therapy or in combination with CRRT. The planned treatment duration with PrismaLung+ for patients in the study group is 7 days. However, the Investigator can discontinue PrismaLung+ treatment before 7 days if ECCO2R is no longer required. Following the 7-day treatment period, the Investigator will assess the patient's condition to determine whether to continue ECCO2R. Patients will require systemic anticoagulation with heparin during ECCO2R treatment. Continuous renal replacement therapy may be administered concurrently to patients during the study, if needed, at the discretion of the Investigator. During the study, patients will be given active treatment for their primary disease.
Invasive Mechanical Ventilation
Other interventionAccording to the standard clinical practice of IMV, oral or nasal endotracheal intubation can be used for IMV. The initial mode of IMV and ventilatory parameters will be determined based on the patient's condition, and an appropriate patient-centered LPV approach will be selected to adjust the ventilatory parameters to achieve the study LPV strategy. Appropriate treatments other than ECCO2R will be provided for this group. Continuous renal replacement therapy may be administered concurrently to patients during the study, if needed, at the discretion of the Investigator. During the study, patients will be given active treatment for their primary disease.
Treatment groups
99 Participants
are divided into 2 treatment groupsGroup A: Patients receiving IMV combined with ECCO2RExperimental treatment 1 intervention
Group B: Patients receiving IMV aloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The percent decrease of partial pressure of carbon dioxide (PaCO2) from baseline after 2h of treatment.
Percent decrease (%) of PaCO2 from baseline based on arterial blood gas 2h after treatment initiation. Must meet the following requirements for data collection: 1. maintained LPV (RR \< 25/min, DP \< 15 cmH2O) with consistent ventilatory parameters with baseline; 2. blood flow rate (Qb) of 300 to 450 mL/min; 3. sweep gas flow rate of 10 L/min.
Time frame
2 hours after treatmentSecondary outcomes
1
CO2 clearance (in the experimental group only)
Blood sampled pre- and post-PrismaLung+ filter to calculate CO2 clearance based on blood gas analysis results.
Time frame
2 hours and 24 hours after treatment2
Changes in Blood Gas Indexes
Change in blood gas indexes before and after treatment based on arterial blood gas at different follow-up timepoints. Blood gas indexes include pH, PaO2, PaCO2, SaO2, standard bicarbonate (SB), actual bicarbonate (AB), and lactic acid.
Time frame
2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment3
Changes in Oxygenation Indexes (PaO2/FiO2)
The ratio of partial pressure of arterial oxygen (PaO2 in mmHg) to fraction of inspired oxygen (FiO2 in %), i.e., PaO₂/FiO₂.
Time frame
2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment4
Changes in Ventilatory Parameters
Changes in respiratory rate (RR). The following definitions on ventilatory parameters are for reference and the specific parameters are based on the ventilator mode at each site. RR refers to the number of breaths per minute of a ventilator, measured in breaths/min.
Time frame
2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatmentSponsors and contacts
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Source ClinicalTrials.gov