TIVAD implantation complications
ProcedureFollow up and post operative outcome of patients with devices implantation
NCT Number: NCT06644885
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.
Trial opening soon.
Get NotifiedUp to 18 year
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Follow up and post operative outcome of patients with devices implantation
Time frame: 1 year
Risk factors for cephalic vein cutdown failure for TIVAD positioning
Time frame: 1 year
Post-operative complications of cephalic vein cutdown
Time frame: 1 year
Time frame: 1 year
Contact information is provided by the study sponsor or research team.
University Hospital, Angers
Other Gov
Acronym: SitePedia
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.
Published trials that share one or more normalized conditions with this study.
NCT04487548
Behavior, Health Behavior
New Westminster, British Columbia, Canada
View Trial DetailsNCT06968884
Behavior, Neoplasms
Stockholm, Stockholm County, Sweden
View Trial DetailsNCT04281680
Surgical Complications
View Trial DetailsNCT01593657
Abdominal Surgery by Laparotomy, Gynecologic Malignancy
Winston-Salem, North Carolina, United States
View Trial Details