Clinical trial NCT04303052: Non-Inferiority Study to Compare the Effectiveness of the Seldinger Over-the-Wire Technique and the Modified Seldinger Technique
Official title: Randomized-Controlled Non-Inferiority Study to Compare the Effectiveness of the Seldinger Over-the-Wire Technique and the Modified Seldinger Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effectiveness and Safety of the Seldinger Wire Technique Using a 145 cm Guidewire With the Modified Seldinger Technique Using a 70 cm Guidewire
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Depending on randomization, the Power-PICC implantation occurs either with Seldinger over-the-wire technique or with Seldinger modified technique. All related substances, measures or procedures are performed according to the clinical routine.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* female, male
* adults ≥ 18 years
* medical indication for Power-PICC-Line catheter implantation because of chemotherapy or parenertal nutrition
* in- and outpatients

Exclusion Criteria:

* age \< 18 years
* systemic infection
* local infection of the interventional location
* known allergy to used material
* general contraindication of Power-PICC-Line catheter implantation

Primary outcomes:
measure: Implantation time
timeFrame: 24 hours
Secondary outcomes:
measure: Placement accuracy of catheter tip compared to chest x-ray
timeFrame: 24 hours
Other outcomes:
Locations:
city: Jena
country: Germany
facility: University Hospital Jena
state: Thuringia
Study officials:
affiliation: Institute of Diagnostic and Interventional Radiology
name: Heike Habrecht, Dr.
role: PRINCIPAL_INVESTIGATOR
References: