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NCT Number: NCT05124821

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

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.

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Key information

Conditions

Central Venous Catheter

Age range

1 day–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Hochschule Hannover, Klinik für Pädiatrische Kardiologie und Pädiatrische Intensivmedizin, Hanover, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Other names: Certofix® Paed

Primary outcomes

  1. Late complications

    Time frame: up to 30 days

    Incidence of thrombosis

  2. Late complications

    Time frame: up to 30 days

    Incidence of occlusion

  3. Late complications

    Time frame: up to 30 days

    Incidence of catheter insertion site infection

  4. Late complications

    Time frame: up to 30 days

    Incidence of malpositioning of catheter due to dislodgement or migration

Secondary outcomes

  1. Early complications of central venous catheter application

    Time frame: Up to 2 hours

  2. Incidence of systemic infection

    Time frame: up to 30 days

  3. Catheter handling details

    Time frame: up to 30 days

    Number of emergency applications of the catheter

  4. Catheter handling details

    Time frame: up to 30 days

    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

  5. Catheter handling details

    Time frame: up to 30 days

    Place of positioning of catheter

  6. Catheter handling details

    Time frame: up to 30 days

    Ultrasound guided central venous catheter application

  7. Catheter handling details

    Time frame: up to 30 days

    Control of catheter positioning: radiologic, ECG

  8. Catheter handling details

    Time frame: up to 30 days

    Date of catheter insertion and removal

  9. Catheter handling details

    Time frame: up to 30 days

    Time of catheter insertion and removal

  10. Catheter handling details

    Time frame: up to 30 days

    Catheter fixation

  11. Catheter handling details

    Time frame: up to 30 days

    Catheter Care

  12. Catheter handling details

    Time frame: up to 30 days

    Observations on catheter quality

  13. Concomitant medication

    Time frame: up to 30 days

    Use of antibiotics or other relevant medication

  14. Adverse Device Effect (ADE)

    Time frame: up to 30 days

  15. Device Deficiency (DD)

    Time frame: up to 30 days

    Device deficiency

  16. Device Deficiency (DD)

    Time frame: up to 30 days

    Duration of device deficiency

  17. Device Deficiency (DD)

    Time frame: up to 30 days

    Action taken

  18. Serious Adverse Event (SAE)

    Time frame: up to 30 days

  19. Serious Adverse Device Effect (SADE)

    Time frame: up to 30 days

  20. Catheter variables

    Time frame: up to 30 days

    Number of lumen

  21. Catheter variables

    Time frame: up to 30 days

    Size

  22. Catheter variables

    Time frame: up to 30 days

    Length

  23. Reason for removal of catheter

    Time frame: up to 30 days

    Regular end of infusion therapy or removal according to local standards

  24. Reason for removal of catheter

    Time frame: up to 30 days

    Upcoming sings of infection on puncture site: skin reddening, swelling, pain, increased skin temperature, fever with unclear origin, other

  25. Reason for removal of catheter

    Time frame: up to 30 days

    Early complication

  26. Reason for removal of catheter

    Time frame: up to 30 days

    Late complication

  27. Reason for removal of catheter

    Time frame: up to 30 days

    Technical problems with the catheter

  28. Demographic data

    Time frame: Prior study start

    Age

  29. Demographic data

    Time frame: Prior study start

    Sex

  30. Demographic data

    Time frame: Prior study start

    Ethnicity

Sponsors and collaborators

Lead sponsor

B. Braun Melsungen AG

Industry

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2021
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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