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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 99
- 试验地点
- 18
- 主要终点
- The percent decrease of partial pressure of carbon dioxide (PaCO2) from baseline after 2h of treatment.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Patients receiving IMV combined with ECCO2R
Patients will receive IMV combined with ECCO2R using PrismaLung+.
干预措施: PrismaLung+ (Device)
Patients receiving IMV alone
干预措施: Invasive Mechanical Ventilation (Other)
结局指标
主要结局
The percent decrease of partial pressure of carbon dioxide (PaCO2) from baseline after 2h of treatment.
时间窗: 2 hours after 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.
次要结局
- CO2 clearance (in the experimental group only)(2 hours and 24 hours after treatment)
- Changes in Blood Gas Indexes(2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment)
- Changes in Oxygenation Indexes (PaO2/FiO2)(2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment)
- Ventilator-Free Days(28 days after enrollment)
- Days of ICU stay(28 days after enrollment)
- 28-day mortality(28 days after enrollment)
- Quality of life (QoL)(1 day of regaining consciousness, 28 days after enrollment.)
- Changes in Ventilatory Parameters(2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment)