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.

Study Overview

• Status: Recruiting
• Conditions: Central Venous Catheter
• Intervention / Treatment: Device: Central venous catheter intended to be used for children during routine clinical practice

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Study Manager; Phone Number: +49-5661-71-0; Email: studies@bbraun.com

Study Locations

• Germany
  • Hannover, Germany, 30625
    • Not yet recruiting
    • Medizinische Hochschule Hannover, Klinik für Pädiatrische Kardiologie und Pädiatrische Intensivmedizin
    • Contact: Michael Sasse, Dr. med.
• Italy
  • Genova, Italy, 16147
    • Recruiting
    • Istituto Giannina Gaslini, Anesthesia and Acute and Procedural Pain Therapy
    • Contact: Andrea Wolfler, Dr. med.
  • Milano, Italy, 20154
    • Recruiting
    • Ospedale de Bambini Vittore Buzzi
    • Contact: Anna Camporesi, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 17 years (Child)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Certofix Paed; 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; Device will applied according to instruction for use (IFU) and respective indication during routine clinical practice.; Other Names: Certofix® Paed

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: B. Braun Melsungen AG
• Investigators: Study Chair: Michael Sasse, Dr. med., Hannover Medical School

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (Actual): November 18, 2021

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Central Venous Catheter; Paediatrics; Post Marketing Clinical Follow-up; Seldinger Technique
• Other Study ID Numbers: HC-O-H-2001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No