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

NCT06904651 | Active Not Recruiting

• 1 other identifier: PG0003287
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Midline Catheter; Orthopedic Surgery

Keywords

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

Outcome Measures

Primary Outcomes (1)

• OPERATING ROOM TIME SAVING

  Estimate of operating room time savings, calculated as hours/year recovered, otherwise used for intra-operative positioning of such devices and/or emergency invasive devices

  one year

Study Arms (1)

ALL Patients with EA-DIVA SCORE >8 undergoing all type of orthopedic surgery

EXPERIMENTAL

Pre-operative positioning of advanced peripherally inserted vascular access

Device: pre-operative positioning of peripherally inserted vascular accesses devices such as midline or minimidline

Interventions

pre-operative positioning of peripherally inserted vascular accesses devices such as midline or minimidline DEVICE

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

ALL Patients with EA-DIVA SCORE >8 undergoing all type of orthopedic surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

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

Bologna, BO, 40133, Italy

Location

Study Officials

• Monica La Sala, Medicine- Anaesthesiology

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: March 5, 2025
• Primary Completion (Estimated): March 5, 2027
• Study Completion (Estimated): March 21, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)