A Prospective, Multicentre, Randomized, Open, Parallel Controlled Clinical Trial for Evaluating the Safety and Effectiveness of CATHTONG™ II PICC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 4
- 主要终点
- Successful rate of one-time catheterization
研究概览
简要总结
This clinical trial is a prospective, multi-centre, open, parallel and comparative non-inferior trial design.
详细描述
Four clinical trial institutions that meet the national qualification are selected as clinical research centers. After informed consent of the subjects and meeting the selection criteria, the subjects will be included in this clinical study. After the follow-up, all the data were sorted out and analyzed. Finally, the data of the two groups were compared to prove whether the high-pressure-resistant peripherally inserted central venous catheter developed by L&Z US, Inc. was not inferior to the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects volunteered to participate in the trial and signed the informed consent.
- •Age 18 years old, 80 years old; gender is not limited;
- •Suitable for patients who need central venous catheterization via peripheral venipuncture (life expectancy is more than 6 months): need medium-term and long-term infusion or intravenous drug therapy; need multi-chamber infusion of multiple drugs at the same time; need infusion of irritating, corrosive or hyperosmotic drugs; hyperbaric angiography or central venous pressure monitoring function;
- •Patients who need to be maintained in the investigator's hospital after PICC catheterization;
- •Ability to communicate well with researchers and comply with test requirements.
排除标准
- •Local infection of puncture vein or occlusion or serious lesion of blood vessel at puncture place;
- •Patients with known or suspected allergies to polyurethane;
- •Pre-intubation site includes trauma history, vascular surgery history, thrombosis history, radiotherapy history, bilateral breast cancer surgery affected upper limbs, superior vena cava compression syndrome, etc.
- •The prothrombin time was 6 seconds longer than the normal value and the activated partial thromboplastin time was 2.5 times longer than the normal value.
- •Pregnancy and lactation women;
- •The subjects had a history of difficulty in catheterization.
- •Patients with pacemaker implantation in vivo;
- •Researchers do not consider it appropriate to participate in this clinical trial.
结局指标
主要结局
Successful rate of one-time catheterization
时间窗: Day 1
Subcutaneous detection of blood vessel movements less than three times, and finally completed catheterization and confirmed that the end of the catheter in the pre-positioning proportion of the total number of patients (catheterization success refers to the chest X-ray and other fluoroscopy means to confirm that the end of the catheter is located in the middle and lower segment of superior vena cava).
次要结局
- success rate of one puncture.(Day 1)
- Operating time(Day 1)
- The incidence of adverse events(about three months)