Effectiveness and Safety of the Seldinger Wire Technique Using a 145 cm Guidewire With the Modified Seldinger Technique Using a 70 cm Guidewire Clinical Trial
Official title:
Randomized-Controlled Non-Inferiority Study to Compare the Effectiveness of the Seldinger Over-the-Wire Technique and the Modified Seldinger Technique
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.
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.
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