Complications of the Cephalic Route in Implantable Site Placement in Children

NCT06644885 | Not Yet Recruiting

• 1 other identifier: 49RC24_0097
• Study Type: observational
• Target: 426
• Locations: 0 countries
• Sites: N/A

Brief Summary

Totally implantable venous access devices (TIVADs) offer long-term central venous access for children requiring intravenous treatments. Their use is recommended in infants (31 days - 1 year old) for \>31 days of non-peripherally compatible therapy, and in children and adolescents (\>1 year old) for any intravenous therapy lasting more than 31 days. Indications include chemotherapy administration and chronic disease management, avoiding repeated peripheral venous punctures and causing less interference with the activities of the patients. There are several methods for TIVAD placement, but the optimal evidence-based method remains unclear . The two main approaches for TIVAD placement are closed cannulation of a vein, followed by insertion of the catheter in Seldinger technique, and the surgical insertion of the catheter into a vein through an open cut-down technique 5-7. Different location of insertion are possible: by closed cannulation, the catheter is usually placed in subclavian vein, internal jugular vein, and brachiocephalic vein; by open cut-down it can be placed in external jugular vein, axillary vein, or cephalic vein. Thanks to progress in medical and surgical care, children are nowadays surviving previously fatal illnesses, but with the need of long-term treatments. For this reason, it's essential to preserve their vessel health. With this objective, in the CHU of Angers, physicians prefer trying first the cephalic vein cutdown for TIVAD positioning in children, reserving the use of other venous accesses in case of failure of this procedure or the need for multiple devices implantations. To date, few reports have been published about cephalic vein cutdown in children. It is a common opinion that this technique can't be successfully performed in patients under a certain limit of weight or age. In this context, the investigators conducted a retrospective single-centre study to analyse the results of cephalic vein cutdown in children. The primary aim was to describe the feasibility of this technique in paediatric population and identify the risks factors associated with its failure. In addition, this study describes indications, outcomes, and complications of TIVAD implantation.

Conditions

Surgical Complications; Device Safety

Outcome Measures

Primary Outcomes (1)

• Characteristics of the study group

  Risk factors for cephalic vein cutdown failure for TIVAD positioning

  1 year

Secondary Outcomes (3)

• cephalic vein cutdown

  1 year

• Post-operative complications

  1 year

• TIVAD removal

  1 year

Study Arms (1)

Patients with TIVAD

Procedure: TIVAD implantation complications

Interventions

TIVAD implantation complications PROCEDURE

Follow up and post operative outcome of patients with devices implantation

Patients with TIVAD

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients operated in the CHU of Angers

You may qualify if:

• All patients under 18 years who underwent TIVAD implantation between 2012 and 2022.
• Patients for whom cephalic vein cutdown was the first attempted surgical technique for device placement.

You may not qualify if:

• Patients who previously had a central venous access

Sponsors & Collaborators

• University Hospital, Angers: lead

Central Study Contacts

Aurora MARIANI

CONTACT

0241353637; Aurora.Mariani@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 16, 2024
• Study Start: December 15, 2024
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: October 16, 2024

Record last verified: 2024-10