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

NCT ID: NCT05124821

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-19
• Study Completion Date: 2024-04-22

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

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

Intervention Type: DEVICE

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

Interventions

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

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

Intervention Type: DEVICE

Other Intervention Names

Certofix® Paed

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B. Braun Melsungen AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Sasse, Dr. med.

Role: STUDY_CHAIR

Hannover Medical School

Locations

Medizinische Hochschule Hannover, Klinik für Pädiatrische Kardiologie und Pädiatrische Intensivmedizin

Hanover, , Germany

Istituto Giannina Gaslini, Anesthesia and Acute and Procedural Pain Therapy

Genova, , Italy

Ospedale de Bambini Vittore Buzzi

Milan, , Italy

Countries

Germany; Italy

Other Identifiers

HC-O-H-2001

Identifier Type: -

Identifier Source: org_study_id