Clinical trial NCT06904651: VADIOR: Advantages of Pre-operative Positioning of Peripherally Inserted Vascular Accesses in DIVA Patients Undergoing Orthopedic Surgery
Official title: VADIOR: Vantaggi Del Posizionamento Preoperatorio Di Accessi Vascolari Avanzati Ad Inserzione Periferica Nel Paziente DIVA Candidato Ad Intervento Ortopedico
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Midline Catheter
Orthopedic Surgery
Keywords: ea-diva score, preoperative positioning of peripheral venous accesses
operating room time save
reduction of operating room cost
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

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

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

Primary outcomes:
measure: OPERATING ROOM TIME SAVING
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS - Istituto Ortopedico Rizzoli Via di Barbiano 1/10 40136 Bologna Italy
state: BO
Study officials:
affiliation: IRCCS - Istituto Ortopedico Rizzoli Via di Barbiano 1/10 40136 Bologna Italy
name: Monica La Sala, Medicine- Anaesthesiology
role: PRINCIPAL_INVESTIGATOR
References: