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

Sponsor

Jena University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04303052

Collaborator

(none)

Enrollment

Location

Arms

19.9

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Effectiveness and Safety of the Seldinger Wire Technique Using a 145 cm Guidewire With the Modified Seldinger Technique Using a 70 cm Guidewire	Device: Angiodynamic Bioflo Picc IR-KIT (145 cm guidewire) or Device: Angiodynamic Bioflo Picc MST-KIT (70 cm guidewire)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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 (Participant)

Masking Description:

On the intervention day, the patient is randomly assigned to one of the two study arms through envelope (145 cm vs 70 cm)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 2, 2018

Actual Primary Completion Date :

Aug 28, 2019

Actual Study Completion Date :

Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: over-the-wire technique with 145 cm guidewire Catheter tip placement using Seldinger over-the-wire technique with 145 cm guidewire	Device: Angiodynamic Bioflo Picc IR-KIT (145 cm guidewire) or 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.
Active Comparator: modified technique with 70 cm guidewire Catheter tip placement using Seldinger modified technique with 70 cm guidewire	Device: Angiodynamic Bioflo Picc MST-KIT (70 cm guidewire) 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.

Arm

Intervention/Treatment

Active Comparator: over-the-wire technique with 145 cm guidewire

Catheter tip placement using Seldinger over-the-wire technique with 145 cm guidewire

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

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.

Active Comparator: modified technique with 70 cm guidewire

Catheter tip placement using Seldinger modified technique with 70 cm guidewire

Device: Angiodynamic Bioflo Picc MST-KIT (70 cm guidewire)

Outcome Measures

Primary Outcome Measures

Implantation time [24 hours]
Economy of time until beginning of treatment

Secondary Outcome Measures

Placement accuracy of catheter tip compared to chest x-ray [24 hours]
by final chest X-ray

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Jena	Jena	Thuringia	Germany	07740

Sponsors and Collaborators

Jena University Hospital

Investigators

Principal Investigator: Heike Habrecht, Dr., Institute of Diagnostic and Interventional Radiology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jena University Hospital

ClinicalTrials.gov Identifier:

NCT04303052

Other Study ID Numbers:

5385-12/17

First Posted:

Mar 10, 2020

Last Update Posted:

Mar 10, 2020

Last Verified:

Mar 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 10, 2020