Research on the Localization Accuracy of PICC Guided by EDUG in Real World
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- the rate of once in place
研究概览
简要总结
This study is a multi-center clinical study, 3000 cases, 25 centers in the country involved, carry out the guidance of EDUG PICC standardized operation at the same period. Each center assists to use app to collect research data.The experimental data will be collected, processed and analyzed by the sponsor and the researchers, and the clinical effect of EDUG will be evaluated according to the results (like the rate of once in place, the number of adjustment times before X-ray, the length of time during the whole catheter placement, the ectopic incidence during PICC first implantation and so on, the special content can be seen in the next indicator section)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Patient≥18 years old
- •Follow the doctor's advice,patients who need to be placed PICC for the first time.
- •No serious cardiovascular diseases, such as atrial fibrillation,pulmonary heart disease and other P wave abnormalities, severe heart block, etc.
- •Patients who did not participate in other clinical studies；
- •Patients who volunteer to participate the clinical study, sign the informed consent and cooperate with the clinical follow-up.
排除标准
- •Patients who have partial deformity or scar formation
- •Patients whose puncture site were infected or damaged
- •Patients who have sclerosis or the cord like change of the vein
- •Patients have compressed vessel by tumor
- •Patients who are confirmed or suspected having infection, bacteremia, or sepsis related to the catheter
- •Patients whose size are not fit to insert the PICC
- •Patients who are confirmed or suspected sensitive to silica gel
- •Patients who have history of radiotherapy in the pre-insertion section
- •Patients who have history of venous thrombosis, trauma, or vascular surgery
- •Patients who have superior vena cava syndrome
- •Patients who were always not following up with the doctors
- •Patients who have severe peripheral edema
- •Patients who may be required a high flow of fluid infusion, hemodialysis, pacemaker, crutches or A-V fistulation
研究组 & 干预措施
PICC guided by EDUG
PICC(Peripherally Inserted Central Catheter)guided by ECG Doppler ultrasonic Guidance（EDUG),EDUG is a combination device which can be used for selecting the right vein and precise positioning for the catheter tip during the PICC cathetering.
干预措施: PICC guided by EDUG (Device)
结局指标
主要结局
the rate of once in place
时间窗: From the date of admitting to hospital until completion of the trial, up to 6 months.
judge weather the catheter tip location guided by the EDUG is accuracy by compare the results with the Xray
次要结局
- the number of cathetering times after X-ray(From the date of admitting until discharge to hospital, up to 14 days.)
- the number of adjustment times before X-ray(From the date of admitting until discharge to hospital, up to 14 days.)
- the length of time during the whole catheter placement before X-ray(From the date of admitting until discharge to hospital, up to 14 days.)
- the convenience of the operation(From the date of admitting until discharge to hospital, up to 14 days.)
- record the adverse events(0,24,48,72 hours and 7days after completing the whole cathetering operation; Every 7 days from completing the whole cathering operation until tube drawing whichever came first, assessed up to 1 year)
- Patient acceptance(From the date of admitting until discharge to hospital, up to 14 days.)