Evaluation of Performance Over Dwell Time and Safety of the Central-venous Catheters Certofix® Paed

NCT05124821 | Completed

• 1 other identifier: HC-O-H-2001
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 3

Brief Summary

Central venous catheterisation is a medical technique that has become established over many decades and can be rated as State of the Art. However, there is only few clinical evidence for the use of Certofix® Paed and additional clinical data need to be collected to underline the long-term performance and safety in paediatric patients. An updated summary overview of Binninger and Roschke describes the potential incidence rates of the classically catheter-related complications, e.g. catheter malposition, catheter fracture, occlusion, thrombosis and catheter-related bloodstream infections (CRBSI) which may have an impact on overall morbidity, mortality and treatment costs. These catheter-related complications should be evaluated in this non-interventional study in paediatric patients.

Conditions

Central Venous Catheter

Keywords

Central Venous Catheter; Paediatrics; Post Marketing Clinical Follow-up; Seldinger Technique

Outcome Measures

Primary Outcomes (4)

• Late complications

  Incidence of thrombosis

  up to 30 days

• Late complications

  Incidence of occlusion

  up to 30 days

• Late complications

  Incidence of catheter insertion site infection

  up to 30 days

• Late complications

  Incidence of malpositioning of catheter due to dislodgement or migration

  up to 30 days

Secondary Outcomes (30)

• Early complications of central venous catheter application

  Up to 2 hours

• Incidence of systemic infection

  up to 30 days

• Catheter handling details

  up to 30 days

• Catheter handling details

  up to 30 days

• Catheter handling details

  up to 30 days

Study Arms (1)

Certofix Paed

Paediatric patients in need for short-term (≤ 30 days) catheterisation of the superior vena cava using the Seldinger technique for infusion and volume therapy or parenteral nutrition, for administration of highly osmolar or very vein-irritating solutions/drugs, for continuous or intermittent monitoring of the central venous pressure, for blood sampling, or when peripheral venous puncture is not possible in state of shock, in patients with injured extremities or no detectable peripheral veins.

Device: Central venous catheter intended to be used for children during routine clinical practice

Interventions

Central venous catheter intended to be used for children during routine clinical practice DEVICE

Device will applied according to instruction for use (IFU) and respective indication during routine clinical practice.

Also known as: Certofix® Paed

Certofix Paed

Eligibility Criteria

• Age: 1 Day - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Paediatric patients in need for short-term (≤ 30 days) catheterisation of the superior vena cava using the Seldinger technique for infusion and volume therapy or parenteral nutrition, for administration of highly osmolar or very vein-irritating solutions/drugs, for continuous or intermittent monitoring of the central venous pressure, for blood sampling, or when peripheral venous puncture is not possible in state of shock, in patients with injured extremities or no detectable peripheral veins.

You may qualify if:

• Written informed assent from patients as well as written informed consent from legal representatives / parents (as applicable)
• Patient's first catheter placement during current hospital stay
• Placement of catheter according to IFU (Instruction for Use)

You may not qualify if:

• Contraindications according to IFU
• Patient has a documented or known allergy/sensitivity to a medical adhesive product such as transparent film, adhesive dressing, tapes or liquid skin protectants

Sponsors & Collaborators

• B. Braun Melsungen AG: lead

Study Sites (3)

Medizinische Hochschule Hannover, Klinik für Pädiatrische Kardiologie und Pädiatrische Intensivmedizin

Hanover, 30625, Germany

Location

Istituto Giannina Gaslini, Anesthesia and Acute and Procedural Pain Therapy

Genova, 16147, Italy

Location

Ospedale de Bambini Vittore Buzzi

Milan, 20154, Italy

Location

Study Officials

• Michael Sasse, Dr. med.

  Hannover Medical School

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: November 18, 2021
• Study Start: May 19, 2023
• Primary Completion: April 22, 2024
• Study Completion: April 22, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); IT (2)