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

B. Braun

Status: Completed

Conditions: Central Venous Catheter

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

Study type: Observational

Funder types: Industry

Identifiers

NCT05124821

HC-O-H-2001

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 1 day to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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
• Inclusion in another interventional study in the field of central-venous catheters which could interfere with the routine clinical practice regarding the application and care of the product until removal

Trial design

100 participants in 1 patient group

Certofix Paed

Description:

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.

Treatment:

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