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

Not Applicable

Completed

• Conditions: Effectiveness and Safety of the Seldinger Wire Technique Using a 145 cm Guidewire With the Modified Seldinger Technique Using a 70 cm Guidewire
• Interventions: Device: Angiodynamic Bioflo Picc MST-KIT (70 cm guidewire); Device: Angiodynamic Bioflo Picc IR-KIT (145 cm guidewire) or

• Registration Number: NCT04303052
• Lead Sponsor: Jena University Hospital

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.

Study Timeline

• Study Start: 2018-02-02
• Study First Submitted: 2019-03-12
• Primary Completion: 2019-08-28
• Study Completion: 2019-10-01
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-09
• Last Update Submitted: 2020-03-09
• Study First Posted: 2020-03-10
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
modified technique with 70 cm guidewire	Angiodynamic Bioflo Picc MST-KIT (70 cm guidewire)	Catheter tip placement using Seldinger modified technique with 70 cm guidewire
over-the-wire technique with 145 cm guidewire	Angiodynamic Bioflo Picc IR-KIT (145 cm guidewire) or	Catheter tip placement using Seldinger over-the-wire technique with 145 cm guidewire

Primary Outcome Measures

Name	Time	Method
Implantation time	24 hours	Economy of time until beginning of treatment

Secondary Outcome Measures

Name	Time	Method
Placement accuracy of catheter tip compared to chest x-ray	24 hours	by final chest X-ray

Trial Locations

Locations (1)

University Hospital Jena; 🇩🇪 Jena, Thuringia, Germany