Open, Randomized, Parallel Controlled Clinical Trial to Evaluate the Safety and Efficacy of Single-use Precision Filtered Infusion Sets for Intravenous Infusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- adverse events and complications
研究概览
简要总结
This study is a pre-market clinical trial of a single-use precision filter infusion set for pumps, to evaluate the safety and effectiveness of a single-use precision filter infusion set for pumps after being used in humans, and to provide clinical evidence for the official application of the product in China
详细描述
This experiment compares the single-use precision filter infusion set produced by Shandong Xinhua Ande Medical Products Co., Ltd. for the same intended use that has been approved to market, and compares the performance of the two products in clinical use, the overall pass rate, and the occurrence of phlebitis Rates and adverse events are used to evaluate the safety and effectiveness of single-use precision filtration infusion sets for pumps.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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 or older, gender not limited;
- •intravenous infusion requiring drug filtration, flow regulation, dosing and extension of infusion line;
- •not participating in other clinical trials within one month;
- •able to understand the purpose of the trial, voluntarily participate and sign the informed consent;
- •willing to follow up and evaluate according to the requirements of the trial protocol.
排除标准
- •Patients with positive pregnancy test in women of childbearing age or lactating women;
- •Patients with uncontrollable cardiomyopathy, heart failure and unable to tolerate infusion;
- •Patients with uncontrollable decompensated renal function, especially in the anuric phase of acute renal failure and unable to tolerate infusion;
- •Patients with uncontrollable extensive inflammation of the lung parenchyma, pulmonary congestion, pulmonary edema and unable to tolerate infusion;
- •0.2um size Test devices combined with any of the following drugs or preparations: fatty milk type, blood products type (blood cells, globulin, etc.), drugs that will produce insoluble precipitates with each other, etc.; 6, patients who are clinically infused with very small amounts of drugs (due to residual test line may reduce the amount of drugs delivered to patients); 7, puncture sites with inflammation, tumors, trauma, scars, etc.; 8, those who may be allergic to product materials; 9 Patients with AIDS;
- •Patients with mental disorders;
- •Other patients who are considered by the investigator to be unsuitable for participation in this study
结局指标
主要结局
adverse events and complications
时间窗: 24 hr after injection
The incidence of adverse events and complications
Vital signs
时间窗: 24 hr after injection
changes in breathing, resting heart rate, blood pressure, body temperature, etc
number of heat source reactions
时间窗: 24 hr after injection
Heat source reactions caused by the application of extension tubes, such as nausea, vomiting, chills, fever, etc., are key safety indicators
次要结局
未报告次要终点