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Completed

NCT Number: NCT04303052

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Jena

Jena, Thuringia, 07740, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Angiodynamic Bioflo Picc IR-KIT (145 cm guidewire) or

Device

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.

Angiodynamic Bioflo Picc MST-KIT (70 cm guidewire)

Device

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.

Primary outcomes

  1. Implantation time

    Time frame: 24 hours

    Economy of time until beginning of treatment

Secondary outcomes

  1. Placement accuracy of catheter tip compared to chest x-ray

    Time frame: 24 hours

    by final chest X-ray

Sponsors and collaborators

Lead sponsor

Jena University Hospital

Other

Registry information

Official study title

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

Acronym: Over-the-Wire

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 10, 2020
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.