Central Venous Catheter
Conditions
Keywords
Central Venous Catheter, Paediatrics, Post Marketing Clinical Follow-up, Seldinger Technique
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.
Interventions
DEVICECentral 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.
Sponsors
B. Braun Melsungen AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late complications | up to 30 days | Incidence of thrombosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of systemic infection | up to 30 days | — |
| Catheter handling details | up to 30 days | Number of emergency applications of the catheter |
| Concomitant medication | up to 30 days | Use of antibiotics or other relevant medication |
| Adverse Device Effect (ADE) | up to 30 days | — |
| Device Deficiency (DD) | up to 30 days | Device deficiency |
| Early complications of central venous catheter application | Up to 2 hours | — |
| Serious Adverse Device Effect (SADE) | up to 30 days | — |
| Catheter variables | up to 30 days | Number of lumen |
| Reason for removal of catheter | up to 30 days | Regular end of infusion therapy or removal according to local standards |
| Demographic data | Prior study start | Age |
| Serious Adverse Event (SAE) | up to 30 days | — |
Countries
Germany, Italy
Outcome results
None listed