NCT07800325已完成不适用
The Safety and Efficacy of ECMO in the Management of Patients With Respiratory Failure
Life Shield Medical Technology Co., LTD1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- survival
研究概览
简要总结
Evaluation of the efficacy and safety of the Rengine extracorporeal cardiopulmonary support system and the ECMO sterile oxygenator in the management of respiratory failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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, male or female;
- •Patients with respiratory failure and high Paco2, PH < 7.35；
- •Researchers believe that this product is beneficial for patients undergoing treatment, such as patients with invasive ventilator weaning difficulty, large airway obstruction, etc；
- •Patients or guardians provided written informed consent voluntarily.
排除标准
- •Oxygenation index <80mmHg;
- •Intracranial hemorrhage or severe irreversible brain injury;
- •Thrombocytopenia;
- •Patients with malignant tumors (expected survival time <1 year);
- •patients unable to receive systemic anticoagulation;
- •Obesity: BMI>40kg/m2;
- •Those with a history of mental illness who were unable to cooperate in completing the trial;
- •During pregnancy and lactation;
- •Patients with allergic or severe allergic constitution to the test equipment;
- •Participated in other interventional device clinical trials within 3 months before this trial
- •Those who were deemed unsuitable to participate in the trial by the investigators.
研究组 & 干预措施
ECMO
Experimental
Using ECMO in the management of respiratory failure
干预措施: ECMO (Other)
结局指标
主要结局
survival
时间窗: Day 7 post-treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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