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

Istituto Ortopedico Rizzoli

Status: Active, not recruiting

Conditions: Orthopedic Surgery; Midline Catheter

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06904651

PG0003287

Details and patient eligibility

About

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

Full 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

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

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

Experimental group

Description:

Pre-operative positioning of advanced peripherally inserted vascular access

Treatment:

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