Development and Evaluation of an Algorithm for Vascular Access Management

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patient inclusion criteria: adult patients, initially requiring at least one peripheral venous catheter (PVC), having given their consent for the study.

Inclusion criteria for healthcare professionals: Nurses, specialized nurses (IADE) and physicians attached to the department.

Disqualifiers

Minor patients

Patients under curators 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, specific to certain centers and equipped upstream)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Implementation of the A-DIVA Scale

    Other intervention

    Phase 2 aims to evaluate the impact of the implementation of the A-DIVA Scale (classification score for difficult intravenous access) on practitioners' approaches to the peripheral venous catheter placement. It consists of a systematic collection of peripheral venous catheter placement practices for quantitative data and a questionnaire of professionals' opinions on the use of the A-DIVA scale for qualitative data. The main objective of this phase is to recognize the potential appearance of changes in practices through the implementation of a tool for evaluating vascular access difficulties

  • Implementation of the algorithm composed of the A-DIVA Scale and the new decision-making tree (the A-DIVA Tool) in the centers

    Other intervention

    The main objective of this phase is to evaluate the impact of the algorithm on the quality of peripheral venous catheter placement. • Systematic collection of judgment criteria and socio-demographic and clinical characteristics of patients. Description of the care strategy implemented. Systematic collection of the A-DIVA Scale with identification of the patient's risk group, systematic rating of pain and evaluation of overall comfort.

Treatment groups

794 Participants
are divided into 2 treatment groups
Group A: The control groupOther 1 intervention
Group B: The experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

1. Number of venipunctures performed per patient after implementation of the algorithm

Number of punctures performed per patient after implementation of the algorithm (collection according to a data grid filled in by the operator after the care).

Time frame
20 months

Secondary outcomes

1

2. Number of participants who approve the co-constructed algorithm.

Co-construct a catheter placement algorithm based on the venous access difficulty score

Time frame
8 months
2

3. Acceptability and feasibility of using the VAD score in isolation and the score in conjunction with the catheter placement algorithm

To meet this objective, caregivers' appreciation, use and feelings regarding the vascular access difficulties score and algorithm will be measured using a 23-item questionnaire scored on a 4-point Likert scale ("strongly disagree", "disagree", "agree", "strongly agree"). This questionnaire will also measure the effect of the vascular access difficulties score and the algorithm on practices.

Time frame
4 months
3

Patient pain score measured immediately after vascular puncture (phase of potential acute pain during catheter insertion) using a self-assessment tool (numerical scale ranging from 0: no pain; 10: maximum pain)

Describe how patients feel in terms of pain during care and overall comfort before and after the implementation of a catheter placement algorithm

Time frame
8 months and 16 months
4

5. Number of venipunctures performed per patient after implementation of the venous access difficulty score

Evaluate the effect of implementing the venous access difficulty score on the average number of venipunctures per patient

Time frame
8 months

Other outcomes

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