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

Central Venous Catheter Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05124821
• Other study ID #: HC-O-H-2001
• Status: Recruiting
• Start date: May 19, 2023
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: B. Braun Melsungen AG
• Contact: Study Manager
• Phone: +49-5661-71-0
• Email: studies[@]bbraun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Venous Catheter

Intervention

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.

Locations

Country	Name	City	State
Germany	Medizinische Hochschule Hannover, Klinik für Pädiatrische Kardiologie und Pädiatrische Intensivmedizin	Hannover
Italy	Istituto Giannina Gaslini, Anesthesia and Acute and Procedural Pain Therapy	Genova
Italy	Ospedale de Bambini Vittore Buzzi	Milano

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Melsungen AG

Countries where clinical trial is conducted

Germany,  Italy, 

Outcome

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