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

Study Overview
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Brief Summary
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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.

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

Conditions
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Central Venous Catheter

Intervention / Treatment
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* Device: Central venous catheter intended to be used for children during routine clinical practice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Certofix Paed<br>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<br>* Device will applied according to instruction for use (IFU) and respective indication during routine clinical practice.<br>* Other names: Certofix® Paed;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early complications of central venous catheter application |  | Up to 2 hours | 
| Incidence of systemic infection |  | up to 30 days | 
| Catheter handling details | Number of emergency applications of the catheter | up to 30 days | 
| Catheter handling details | Reason for insertion of catheter: infusion and volume therapy, parenteral nutrition, administration of highly osmolar solutions, administration of very vein-irritating solutions, continuous or intermittent monitoring of the central venous pressure, peripheral venous puncture was not successful or veins not detectable | up to 30 days | 
| Catheter handling details | Place of positioning of catheter | up to 30 days | 
| Catheter handling details | Ultrasound guided central venous catheter application | up to 30 days | 
| Catheter handling details | Control of catheter positioning: radiologic, ECG | up to 30 days | 
| Catheter handling details | Date of catheter insertion and removal | up to 30 days | 
| Catheter handling details | Time of catheter insertion and removal | up to 30 days | 
| Catheter handling details | Catheter fixation | up to 30 days | 
| Catheter handling details | Catheter Care | up to 30 days | 
| Catheter handling details | Observations on catheter quality | up to 30 days | 
| Concomitant medication | Use of antibiotics or other relevant medication | up to 30 days | 
| Adverse Device Effect (ADE) |  | up to 30 days | 
| Device Deficiency (DD) | Device deficiency | up to 30 days | 
| Device Deficiency (DD) | Duration of device deficiency | up to 30 days | 
| Device Deficiency (DD) | Action taken | up to 30 days | 
| Serious Adverse Event (SAE) |  | up to 30 days | 
| Serious Adverse Device Effect (SADE) |  | up to 30 days | 
| Catheter variables | Number of lumen | up to 30 days | 
| Catheter variables | Size | up to 30 days | 
| Catheter variables | Length | up to 30 days | 
| Reason for removal of catheter | Regular end of infusion therapy or removal according to local standards | up to 30 days | 
| Reason for removal of catheter | Upcoming sings of infection on puncture site: skin reddening, swelling, pain, increased skin temperature, fever with unclear origin, other | up to 30 days | 
| Reason for removal of catheter | Early complication | up to 30 days | 
| Reason for removal of catheter | Late complication | up to 30 days | 
| Reason for removal of catheter | Technical problems with the catheter | up to 30 days | 
| Demographic data | Age | Prior study start | 
| Demographic data | Sex | Prior study start | 
| Demographic data | Ethnicity | Prior study start | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Central Venous Catheter, Paediatrics, Post Marketing Clinical Follow-up, Seldinger Technique