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Tests treatment safety and results for Acute Respiratory Distress Syndrome
Official title A Study of the Efficacy and Safety of Extracorporeal Carbon Dioxide Removal Using PrismaLung+
ClinicalTrials.gov ID: NCT07326215
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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.
- Expected to require extracorporeal membrane oxygenator (ECMO) treatment within 24h after enrollment.
- Patient's primary disease is expected to worsen rapidly or require other surgical intervention within 24h after enrollment.
See the full eligibility criteria
- 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...
- 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.
- Expected to require extracorporeal membrane oxygenator (ECMO) treatment within 24h after enrollment.
- Patient's primary disease is expected to worsen rapidly or require other surgical intervention within 24h after enrollment.
- Diagnosed as brain dead or in a vegetative state.
- Pregnant and/or breastfeeding.
- 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.
- Patients is considered as unsuitable for participating in the study, as judged by the Investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
- Harbin, Heilongjiang, China
- Nanjing, Jiangsu, China
- Nanchang, Jiangxi, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Shenzhen, Guangdong, China; Harbin, Heilongjiang, China; Nanjing, Jiangsu, China; Nanchang, Jiangxi, China and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.