The Impact of Climate Environment in Different Latitudes on the Occurrence of PICC Complications and Intervention Measures - Prospective, Multicenter, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,666
- 主要终点
- rate of complications
研究概览
简要总结
In this study, eligible subjects were randomly assigned to the experimental or control group through randomization (1:1). Under the guidance of electrocardiographic Doppler ultrasound guided puncture and catheterization (EDUG) technology, the tunnel puncture method was compared with the conventional puncture method. The two groups of patients were observed and evaluated intraoperative and postoperative 7 ± 3 days, 30 ± 7 days, 60 ± 10 days, and 90 ± 10 days 120 ± 10 days (if any) and the occurrence of complications during extubation or unplanned extubation at the end of treatment, comparing cases in the north and south, as well as complications related to different catheterization methods
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 18 years old;
- •Patients who follow medical advice and require PICC catheterization;
- •Patients who have not participated in other clinical studies;
- •Patients who voluntarily participate in this clinical study and can cooperate with clinical follow-up;
- •There are no serious cardiovascular diseases, such as atrial fibrillation, pulmonary heart disease, and other P-wave abnormalities before catheterization, as well as severe heart conduction block
排除标准
- •Known allergies to catheter materials;
- •There is a history of infection, injury, and radiation therapy at the puncture site;
- •The puncture site has a history of venous thrombosis or surgery;
- •Severe abnormal coagulation function;
- •Superior vena cava compression syndrome;
- •Surgical side limbs of breast cancer patients undergoing radical mastectomy or axillary lymph node dissection;
- •Heart pacemaker and arteriovenous fistula on the same side of the limb;
- •Patients or patients' family members refuse to sign the informed consent form.
研究组 & 干预措施
trial group
干预措施: tunneled PICC (Device)
control group
干预措施: routine PICC (Device)
结局指标
主要结局
rate of complications
时间窗: 120 days after operation
次要结局
- time of catheter retention(7, 30, 60, 90 and 120 days after operation)