Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT05935228

Development and Evaluation of an Algorithm for Vascular Access Management

Led by Central Hospital, Nancy, France · Updated on 2026-04-29

794

Participants Needed

1

Research Sites

183 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Two billion catheters are placed annually worldwide. Of all the people requiring vascular access, nearly a quarter have Difficult Intravenous access (DIVA), a source of multiple punctures. The increased risk of haematomas, haemorrhages, infection, pain and associated trauma is responsible for increased human costs and economic impact. To limit the risks posed by the DIVA, practitioners have solutions such as the per-bone line, other types of lines, and placement of peripheral venous catheter with ultrasound or transluminescence. However, these solutions are not always applicable, depending on the care situation (non-substitutable venous access, fragile patient, etc.) or on the technical platform (available personnel and training, configuration of the premises, available equipment). Moreover, these actions are often taken after failures, in a non-anticipated and non-consensual manner. In order to assess the risk of DIVA, F.Van Loon et al developed in 2016, and then modified in 2018, a DIVA Scale (the A-DIVA Scale) which allows a rapid scoring upstream of peripheral venous catheter placement to classify patients according to the risk of DIVA. Composed of five items (non-palpable and non-visible vein, diameter \< 3mm, history of DIVA, operator experience) worth one point each, the score allows three categories to be established: "low risk", "moderate risk", "high risk". The study showed that the proportion of first puncture failures increased with the risk of the patients (defined according to the categorized score). The use of a tool such as the A-DIVA Scale is of interest if it allows the definition of actions to be taken in relation to the risk it identifies. In view of this, it appears essential to optimize the management of peripheral venous catheters, particularly for patients with DIVAs. The aim of this study is to develop a graduate and specific response to the issue of multiple punctures. Our project is to create and evaluate a specific algorithm, consisting of a risk assessment (the A-DIVA Scale) and a co-construct decision-making tree (the A-DIVA Tool). Built on the basis of objective clinical data collection and adapted to the possibilities and competencies, this new tool would bring real benefits to the patient in terms of safety (reduction of risks) and comfort (reduction of pain and duration of management), as well as a medico-economic benefit for the institutions. To date, such an algorithm does not exist and its beneficial effects have not been evaluated.

CONDITIONS

Official Title

Development and Evaluation of an Algorithm for Vascular Access Management

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients requiring at least one peripheral venous catheter
  • Patients who have given consent for the study
  • Healthcare professionals attached to the department, including nurses, specialized nurses (IADE), and physicians
Not Eligible

You will not qualify if you...

  • Minor patients
  • Patients under curatorship or guardianship
  • Patients who are non-communicative or unable to give consent
  • Patients not requiring a peripheral venous catheter
  • Polytrauma patients and patients in shock (septic, hemorrhagic, cardiogenic, spinal, or specific to certain centers and equipped upstream)
  • Patients who already have catheters on arrival
  • Healthcare professionals not attached to the department or from other professional categories

AI-Screening

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Trial Site Locations

Total: 1 location

1

Center Hospital Nancy

Vandœuvre-lès-Nancy, France, 54 500

Actively Recruiting

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Research Team

A

Amandine OSTERMANN

CONTACT

C

Côme SLOSSE

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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Development and Evaluation of an Algorithm for Vascular Access Management | DecenTrialz