Application of Intracavity Electrocardiogram Positioning Technique in Catheterization of Valvular PICC
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,051
- 主要终点
- Accuracy of tip determination
研究概览
简要总结
This study was a prospective, multicenter, randomized controlled study. The study aimed to exploring the influence of PICC intra catheter guide wire or PICC conductive tip as intra luminal electrode on the positioning accuracy of catheter tip and exploring the influence of PICC intra catheter guide wire or PICC conductive tip as intra luminal electrode on catheterization complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Patients ≥18 years old who need PICC catheterization for the first time according to the doctor's advice;
- •No serious cardiovascular diseases before catheterization, such as atrial fibrillation, pulmonary heart disease and other P wave abnormalities, serious heart block, etc.;
- •patients who did not participate in other clinical studies;
- •Patients who voluntarily participated in the clinical study, signed informed consent and cooperated with clinical follow-up
排除标准
- •patients with local malformation or scar formation;
- •Patients with infection or damage at the puncture site;
- •patients with tumor compression of blood vessels;
- •Patients with confirmed or suspected catheter-related infection, bacteremia and septicemia
- •Patients diagnosed or suspected to be allergic to silicone material
- •Patients with a history of radiotherapy at the pre-intubation site
- •Patients with a history of venous thrombosis, trauma or vascular surgery
- •Patients with superior vena cava syndrome
- •Patients with poor medical behavior
- •Patients with severe peripheral vascular edema
- •High-flow fluid infusion, patients requiring hemodialysis, pacemaker installation, crutches, or patients who may undergo A-V fistula
结局指标
主要结局
Accuracy of tip determination
时间窗: Immediately after surgery
IC-ECG method was used to place the tube, and X-ray was used to determine the accuracy of tip location after confirmation. If the two judgments are inconsistent, the third method, such as echocardiography, shall be used. The tip determination accuracy of IC-ECG localization method and X-ray localization method were calculated respectively.X-ray judgment standard: the reference standard is the first choice of the cardiac shadow method: not exceeding the highest protrusion on the left side of the cardiac shadow (tracheal protrusion method: 0-3cm below the tracheal protrusion); Secondary rib reading method: posterior 5-7 ribs.
次要结局
- Medical costs resulting from complications(After the operation to 180 days)
- rate of convenient(Immediately after surgery)
- Retention duration(After the operation to 180 days)
- success rate of one catheterization(Immediately after surgery)
- incidence of PICC-related complications(After the operation to 180 days)
- rate of unplanned extubation(After the operation to 180 days)