A Prospective, Multicenter, Real-World Clinical Study Provides an Assessment of the Safety and Efficacy of Midline Catheters
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Number of Participants With Catheter-Related Complications
研究概览
简要总结
The goal of this observational study is to learn about the safety and effectiveness of midline catheters in patients who receive midline catheter placement as part of their routine clinical care. The main question it aims to answer is:
Do midline catheters demonstrate acceptable safety and effectiveness when used in routine clinical practice?
Participants who receive a midline catheter as part of their regular medical care will have their clinical data collected from electronic medical records and patient questionnaires, and followed for outcomes related to catheter-related complications and functional performance.
详细描述
Study Title
A prospective multicenter real-world clinical study provides an assessment of the safety and efficacy of midline catheters
Study Description
Background and Why This Study Is Being Done
Midline catheters are intended for patients expected to require intravenous therapy for 1 to 4 weeks. They offer several advantages including rapid insertion, a high safety profile, low maintenance costs, and no need for X-ray confirmation of tip placement. Although midline catheters are widely used in clinical practice internationally, their adoption in China has been relatively late. Research on midline catheters in China remains limited and in its early stages without in-depth investigation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •First-time midline catheter placement per physician order
- •Not enrolled in another clinical study
- •Willing and able to provide informed consent and comply with follow-up (unless consent waived by local ethics committee)
排除标准
- •Deemed unsuitable by investigator (e.g., poor compliance or inability to communicate clearly)
- •Refusal of informed consent by patient or family member
结局指标
主要结局
Number of Participants With Catheter-Related Complications
时间窗: From catheter insertion until removal, assessed up to 28 days
Catheter-related complications include phlebitis, catheter-related bloodstream infection (CRBSI), venous thrombosis, and catheter occlusion. Complication rate is calculated as the number of participants experiencing at least one complication divided by the total number of enrolled participants, multiplied by 100 percent.
次要结局
- One-Time Insertion Success Rate(At catheter insertion, assessed up to 28 days)
- Catheter Dwell Time(From catheter insertion to removal, assessed up to 28 days)
- Unplanned Removal Rate(From catheter insertion to removal, assessed up to 28 days)
- Insertion and Maintenance Cost(From catheter insertion to removal, assessed up to 28 days)
- Patient Satisfaction(At catheter removal, , assessed up to 28 days)
- Catheter Function Rate(At catheter removal, assessed up to 28 days)