NCT06904651

VADIOR: Advantages of Pre-operative Positioning of Peripherally Inserted Vascular Accesses in DIVA Patients Undergoing Orthopedic Surgery

VADIOR: Vantaggi Del Posizionamento Preoperatorio Di Accessi Vascolari Avanzati Ad Inserzione Periferica Nel Paziente DIVA Candidato Ad Intervento Ortopedico

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Our goal is to demonstrate how a standardized approach that involves the pre-operative implantation of the venous access devices in the DIVA patients (EA-DIVA score\> or =8), scheduled for orthopedic surgery, impacts both the intra- and post-operative safety of the patient and the economic savings of our institute. The latter would be achieved both through a reduction in operating room costs and in terms of recovery of operating room hours

Detailed description

Prospective observational cost-effectiveness study. A preliminary evaluation of the EA-DIVA score of all patients who are candidates for surgery will be performed; all patients with an EA-DIVA score \> or = 8 and referred for pre-operative midline or PICC implantation will be prospectively enrolled; anthropometric, anamnestic and clinical parameters of the patient will be collected; indication for implantation, type and characteristics of the implanted device, site of implantation and implantation time will be established by the members of the Vascular Access Team; the DAV follow-up will be performed every 7 days until discharge and/or removal of the device, recording the appearance of signs or symptoms of infection and/or thrombosis and/or other complications. The study setting will be :IRCCS Istituto Ortopedico Rizzoli: all hospitalization departments plus the pre-admission clinic for the enrollment of patients with difficult vascular access, classified according to the EA-DIVA Score; the procedure room of the Post-Operative Intensive Care Unit for the implantation of the devices; hospitalization departments for the post-operative monitoring of any complications

Conditions

• Midline Catheter
• Orthopedic Surgery

Interventions

Type	Name	Description
DEVICE	pre-operative positioning of peripherally inserted vascular accesses devices such as midline or minimidline	pre-operative positioning of peripherally inserted vascular accesses devices such as midline or minimidline ultrasound guided by dedicated vascular access team

Timeline

• Start date: 2025-03-05
• Primary completion: 2026-03-05
• Completion: 2026-03-21
• First posted: 2025-04-01
• Last updated: 2025-04-01

Locations

1 site across 1 country: Italy