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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06904651
Acronym
VADIOR
Enrollment
300
Registered
2025-04-01
Start date
2025-03-05
Completion date
2027-03-21
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Midline Catheter, Orthopedic Surgery

Keywords

ea-diva score, preoperative positioning of peripheral venous accesses, operating room time save, reduction of operating room cost

Brief 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

Interventions

DEVICEpre-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

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model 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 times 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
OPERATING ROOM TIME SAVINGone yearEstimate of operating room time savings, calculated as hours/year recovered, otherwise used for intra-operative positioning of such devices and/or emergency invasive devices

Countries

Italy

Contacts

PRINCIPAL_INVESTIGATORMonica La Sala, Medicine- Anaesthesiology

IRCCS - Istituto Ortopedico Rizzoli Via di Barbiano 1/10 40136 Bologna Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026