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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Effectiveness and Safety of the Seldinger Wire Technique Using a 145 cm Guidewire With the Modified Seldinger Technique Using a 70 cm Guidewire

Intervention / Treatment
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* Device: Angiodynamic Bioflo Picc IR-KIT (145 cm guidewire) or
* Device: Angiodynamic Bioflo Picc MST-KIT (70 cm guidewire)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: over-the-wire technique with 145 cm guidewire<br>Catheter tip placement using Seldinger over-the-wire technique with 145 cm guidewire | Device: Angiodynamic Bioflo Picc IR-KIT (145 cm guidewire) or<br>* Before Power-PICC-line catheter implantation, the patients undergo an examination of the planned intervention site and ultrasound check, and analysis of the blood tests. An informed consent discussion and the patient's signature on the informed consent are obligatory. The length of the catheter and the optimal position of the catheter tip are verified by fluoroscopy. After catheter implantation, the tip location is verified by a final chest x-ray. The follow-up visit and the control of the puncture site until removal of the catheter are performed during hospitalization or subsequently by the treating family doctor.<br>|
| Active Comparator: modified technique with 70 cm guidewire<br>Catheter tip placement using Seldinger modified technique with 70 cm guidewire | Device: Angiodynamic Bioflo Picc MST-KIT (70 cm guidewire)<br>* Before Power-PICC-line catheter implantation, the patients undergo an examination of the planned intervention site and ultrasound check, and analysis of the blood tests. An informed consent discussion and the patient's signature on the informed consent are obligatory. The length of the catheter and the optimal position of the catheter tip are verified by fluoroscopy. After catheter implantation, the tip location is verified by a final chest x-ray. The follow-up visit and the control of the puncture site until removal of the catheter are performed during hospitalization or subsequently by the treating family doctor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation time | Economy of time until beginning of treatment | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Placement accuracy of catheter tip compared to chest x-ray | by final chest X-ray | 24 hours |