Clinical trial NCT05124821: Evaluation of Performance Over Dwell Time and Safety of the Central-venous Catheters Certofix® Paed
Official title: Evaluation of Performance Over Dwell Time and Safety of the Central-venous Catheters Certofix® Paed
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Venous Catheter
Keywords: Central Venous Catheter
Paediatrics
Post Marketing Clinical Follow-up
Seldinger Technique
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2021-11-18
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


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

Primary outcomes:
measure: Late complications
timeFrame: up to 30 days
measure: Late complications
timeFrame: up to 30 days
measure: Late complications
timeFrame: up to 30 days
measure: Late complications
timeFrame: up to 30 days
Secondary outcomes:
measure: Early complications of central venous catheter application
timeFrame: Up to 2 hours
measure: Incidence of systemic infection
timeFrame: up to 30 days
measure: Catheter handling details
timeFrame: up to 30 days
measure: Catheter handling details
timeFrame: up to 30 days
measure: Catheter handling details
timeFrame: up to 30 days
measure: Catheter handling details
timeFrame: up to 30 days
measure: Catheter handling details
timeFrame: up to 30 days
measure: Catheter handling details
timeFrame: up to 30 days
measure: Catheter handling details
timeFrame: up to 30 days
measure: Catheter handling details
timeFrame: up to 30 days
measure: Catheter handling details
timeFrame: up to 30 days
measure: Catheter handling details
timeFrame: up to 30 days
measure: Concomitant medication
timeFrame: up to 30 days
measure: Adverse Device Effect (ADE)
timeFrame: up to 30 days
measure: Device Deficiency (DD)
timeFrame: up to 30 days
measure: Device Deficiency (DD)
timeFrame: up to 30 days
measure: Device Deficiency (DD)
timeFrame: up to 30 days
measure: Serious Adverse Event (SAE)
timeFrame: up to 30 days
measure: Serious Adverse Device Effect (SADE)
timeFrame: up to 30 days
measure: Catheter variables
timeFrame: up to 30 days
measure: Catheter variables
timeFrame: up to 30 days
measure: Catheter variables
timeFrame: up to 30 days
measure: Reason for removal of catheter
timeFrame: up to 30 days
measure: Reason for removal of catheter
timeFrame: up to 30 days
measure: Reason for removal of catheter
timeFrame: up to 30 days
measure: Reason for removal of catheter
timeFrame: up to 30 days
measure: Reason for removal of catheter
timeFrame: up to 30 days
measure: Demographic data
timeFrame: Prior study start
measure: Demographic data
timeFrame: Prior study start
measure: Demographic data
timeFrame: Prior study start
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Klinik für Pädiatrische Kardiologie und Pädiatrische Intensivmedizin
city: Genova
country: Italy
facility: Istituto Giannina Gaslini, Anesthesia and Acute and Procedural Pain Therapy
city: Milano
country: Italy
facility: Ospedale de Bambini Vittore Buzzi
Study officials:
affiliation: Hannover Medical School
name: Michael Sasse, Dr. med.
role: STUDY_CHAIR
References: