VADIOR: Vantaggi Del Posizionamento Preoperatorio di Accessi Vascolari Avanzati ad Inserzione Periferica Nel Paziente DIVA Candidato ad Intervento Ortopedico
| Registry | NCT06904651, acronym VADIOR |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, other |
| Enrollment | 300 (Estimated) |
| Sponsor | Istituto Ortopedico Rizzoli (Other) |
| Conditions | Midline Catheter, Orthopedic Surgery |
| Interventions | pre-operative positioning of peripherally inserted vascular accesses devices such as midline or minimidline (Device) |
| Dates | start 2025-03-05, primary completion 2027-03-05 (estimated), completion 2027-03-21 (estimated), first posted 2025-04-01, last updated 2026-05-22 |
| Locations | 1 site in Italy |
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All trials for Midline Catheter All trials for Orthopedic Surgery All trials of pre-operative positioning of peripherally inserted vascular accesses devices such as midline or minimidline
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
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| ALL Patients with EA-DIVA SCORE >8 undergoing all type of orthopedic surgery | Experimental | Device: pre-operative positioning of peripherally inserted vascular accesses devices such as midline or minimidline | Pre-operative positioning of advanced peripherally inserted vascular access |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Patients of legal age (≥ 18 years). * Patients with a history of documented venous difficulties (DIVA Score > or = 8) * Candidates for surgery in GA or LRA * Patients who have signed the informed consent Exclusion Criteria: * Patients under 18 years of age * Patients with medical or anatomical contraindications to DAV placement in the upper limbs * Local Contraindications: neuromuscular pathologies (long-standing paresis), osteoarticular (fractures, ankylosis), vascular (presence of active DVT affecting the basilar-subclavian-axillary axis), dermatological (infections, burns), lymphatic (axillary lymphadenectomy) * Systemic Contraindications: chronic renal failure grade 3b-4-5, patients on periodic chronic hemodialysis or destined for dialysis, severe thrombocytopenia with platelet count < a 50,000/mm3 (relative contraindication not valid for non-tunneled PICCs, midline and minimidline) * Anatomical contraindications: deep veins of the arm of inadequate caliber for the device
| Facility | City | Country | Status |
|---|---|---|---|
| IRCCS - Istituto Ortopedico Rizzoli Via di Barbiano 1/10 40136 Bologna Italy | Bologna, BO | Italy |