TrialReader


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

NCT06904651 — Not applicable, Active not recruiting, 300 participants, Istituto Ortopedico Rizzoli

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT06904651, acronym VADIOR
StatusActive not recruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, other
Enrollment300 (Estimated)
SponsorIstituto Ortopedico Rizzoli (Other)
ConditionsMidline Catheter, Orthopedic Surgery
Interventionspre-operative positioning of peripherally inserted vascular accesses devices such as midline or minimidline (Device)
Datesstart 2025-03-05, primary completion 2027-03-05 (estimated), completion 2027-03-21 (estimated), first posted 2025-04-01, last updated 2026-05-22
Locations1 site in Italy

Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Midline Catheter All trials for Orthopedic Surgery All trials of pre-operative positioning of peripherally inserted vascular accesses devices such as midline or minimidline

-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

Expand all sections  ·  Collapse all

+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

+Arms and interventions

ArmTypeInterventionsDescription
ALL Patients with EA-DIVA SCORE >8 undergoing all type of orthopedic surgeryExperimentalDevice: pre-operative positioning of peripherally inserted vascular accesses devices such as midline or minimidlinePre-operative positioning of advanced peripherally inserted vascular access
  • 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

+Outcome measures

Primary outcomes

  • OPERATING ROOM TIME SAVING [one year]: 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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
IRCCS - Istituto Ortopedico Rizzoli Via di Barbiano 1/10 40136 Bologna ItalyBologna, BOItaly

+Investigators

My Notes