Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06644885
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
Complications of the Cephalic Route in Implantable Site Placement in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Complications of the Cephalic Route in Implantable Site Placement in Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SitePedia
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 its 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 cant 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
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 its 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 cant 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None