Randomized-Controlled Non-Inferiority Study to Compare the Effectiveness of the Seldinger Over-the-Wire Technique and the Modified Seldinger Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Implantation time
研究概览
简要总结
Peripherally inserted central venous catheter lines (PICC-line) are successfully used since many years in patients who need long-term frequent IV therapy. The PICC placement is performed under fluoroscopy The study objective is to compare the effectiveness and safety of the Seldinger wire technique (over-the-wire) using a 145 cm guidewire with the modified Seldinger technique using a 70 cm guidewire.
详细描述
The referral of patients with indication to PICC-line implantation at the institute of diagnostic and interventional radiology occurs through different departments of the University Hospital Jena. The patients are registered for radiological treatment and checked again by a radiologist if a PICC-line implantation is indicated. If this is the case, the radiologist conducts an informed consent discussion with the patient about possible complications and risks during intervention and informs him also about a possible study participation. After signature of the written informed consent, the patient is included. He can, at any time, withdraw his consent. On the intervention day, the patient is randomly assigned to one of the two study arms through envelope (145 cm vs 70 cm). The intervention time is documented. After intervention, the patient is transferred back to the ward or sent home. The examination of the puncture site before discharge is performed by a ward physician or by the family doctor.
Within 2 weeks after PICC-line implantation, the treating physician is contacted and questioned about possible complications (catheter occlusion, haematoma, infection of the puncture site, arm vein thrombosis, pain, etc.), that are then thoroughly documented.
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 (Participant)
盲法说明
On the intervention day, the patient is randomly assigned to one of the two study arms through envelope (145 cm vs 70 cm)
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
- •female, male
- •adults ≥ 18 years
- •medical indication for Power-PICC-Line catheter implantation because of chemotherapy or parenertal nutrition
- •in- and outpatients
排除标准
- •age < 18 years
- •systemic infection
- •local infection of the interventional location
- •known allergy to used material
- •general contraindication of Power-PICC-Line catheter implantation
研究组 & 干预措施
over-the-wire technique with 145 cm guidewire
Catheter tip placement using Seldinger over-the-wire technique with 145 cm guidewire
干预措施: Angiodynamic Bioflo Picc IR-KIT (145 cm guidewire) or (Device)
modified technique with 70 cm guidewire
Catheter tip placement using Seldinger modified technique with 70 cm guidewire
干预措施: Angiodynamic Bioflo Picc MST-KIT (70 cm guidewire) (Device)
结局指标
主要结局
Implantation time
时间窗: 24 hours
Economy of time until beginning of treatment
次要结局
- Placement accuracy of catheter tip compared to chest x-ray(24 hours)
