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

NCT ID: NCT06904651

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-05
• Study Completion Date: 2026-03-21

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

Conditions

Midline Catheter; Orthopedic Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Pre-operative positioning of advanced peripherally inserted vascular access

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Monica La Sala

Medical Doctor - Anaesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Monica La Sala, Medicine- Anaesthesiology

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Bologna, BO, Italy

Countries

Italy

Other Identifiers

PG0003287

Identifier Type: -

Identifier Source: org_study_id