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.
Study Type
OBSERVATIONAL
Enrollment
100
Device will applied according to instruction for use (IFU) and respective indication during routine clinical practice.
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
Late complications
Incidence of thrombosis
Time frame: up to 30 days
Late complications
Incidence of occlusion
Time frame: up to 30 days
Late complications
Incidence of catheter insertion site infection
Time frame: up to 30 days
Late complications
Incidence of malpositioning of catheter due to dislodgement or migration
Time frame: up to 30 days
Early complications of central venous catheter application
Time frame: Up to 2 hours
Incidence of systemic infection
Time frame: up to 30 days
Catheter handling details
Number of emergency applications of the catheter
Time frame: 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
Time frame: up to 30 days
Catheter handling details
Place of positioning of catheter
Time frame: up to 30 days
Catheter handling details
Ultrasound guided central venous catheter application
Time frame: up to 30 days
Catheter handling details
Control of catheter positioning: radiologic, ECG
Time frame: up to 30 days
Catheter handling details
Date of catheter insertion and removal
Time frame: up to 30 days
Catheter handling details
Time of catheter insertion and removal
Time frame: up to 30 days
Catheter handling details
Catheter fixation
Time frame: up to 30 days
Catheter handling details
Catheter Care
Time frame: up to 30 days
Catheter handling details
Observations on catheter quality
Time frame: up to 30 days
Concomitant medication
Use of antibiotics or other relevant medication
Time frame: up to 30 days
Adverse Device Effect (ADE)
Time frame: up to 30 days
Device Deficiency (DD)
Device deficiency
Time frame: up to 30 days
Device Deficiency (DD)
Duration of device deficiency
Time frame: up to 30 days
Device Deficiency (DD)
Action taken
Time frame: up to 30 days
Serious Adverse Event (SAE)
Time frame: up to 30 days
Serious Adverse Device Effect (SADE)
Time frame: up to 30 days
Catheter variables
Number of lumen
Time frame: up to 30 days
Catheter variables
Size
Time frame: up to 30 days
Catheter variables
Length
Time frame: up to 30 days
Reason for removal of catheter
Regular end of infusion therapy or removal according to local standards
Time frame: 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
Time frame: up to 30 days
Reason for removal of catheter
Early complication
Time frame: up to 30 days
Reason for removal of catheter
Late complication
Time frame: up to 30 days
Reason for removal of catheter
Technical problems with the catheter
Time frame: up to 30 days
Demographic data
Age
Time frame: Prior study start
Demographic data
Sex
Time frame: Prior study start
Demographic data
Ethnicity
Time frame: Prior study start
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