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临床试验/NCT04303052
NCT04303052已完成不适用

Randomized-Controlled Non-Inferiority Study to Compare the Effectiveness of the Seldinger Over-the-Wire Technique and the Modified Seldinger Technique

Jena University Hospital1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2018年2月2日最近更新:
适应症
干预措施

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

Active Comparator

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

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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