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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Orthopedic Surgery; Midline Catheter
• Intervention / Treatment: Device: pre-operative positioning of peripherally inserted vascular accesses devices such as midline or minimidline

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

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40133
      • IRCCS - Istituto Ortopedico Rizzoli Via di Barbiano 1/10 40136 Bologna Italy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALL Patients with EA-DIVA SCORE >8 undergoing all type of orthopedic surgery; Pre-operative positioning of advanced peripherally inserted vascular access	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Investigators: Principal Investigator: Monica La Sala, Medicine- Anaesthesiology, IRCCS - Istituto Ortopedico Rizzoli Via di Barbiano 1/10 40136 Bologna Italy

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2025
• Primary Completion (Estimated): March 5, 2027
• Study Completion (Estimated): March 21, 2027

Study Registration Dates

• First Submitted: March 25, 2025
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: ea-diva score, preoperative positioning of peripheral venous accesses; operating room time save; reduction of operating room cost
• Other Study ID Numbers: PG0003287

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No