Complications of the Cephalic Route in Implantable Site Placement in Children

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorUniversity Hospital, Angers

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients who previously had a central venous access

Trial population

Patients operated in the CHU of Angers

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • TIVAD implantation complications

    Procedure/Surgery

    Follow up and post operative outcome of patients with devices implantation

Treatment groups

426 Participants
are divided into 1 treatment group
Group A: Patients with TIVAD1 intervention

Trial outcomes

Primary outcomes

1

Characteristics of the study group

Risk factors for cephalic vein cutdown failure for TIVAD positioning

Time frame
1 year

Secondary outcomes

1

cephalic vein cutdown

Post-operative complications of cephalic vein cutdown

Time frame
1 year
2

Post-operative complications

Time frame
1 year
3

TIVAD removal

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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