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Recruiting NCT06062199

Impact of Implementing the Modified A-DIVA Scale on Successful Access to a Venous Line on the First Attempt

No phase Interventional Chronic Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Training in the A-DIVA scale and its failure prediction score.
Who it may be relevant to
Registry conditions: Chronic Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Peripheral venous access (PVA), although commonly used, can be a difficult procedure for patients with precarious venous capital. The difficulty of insertion can lead to multiple attempts, with the consequences of pain, anxiety, delayed management and worsening of the potentially already precarious venous capital. One study assessed the risk of failure according to a score based on venous status criteria. This study first established a link between venous status criteria and the risk of failure. The criteria defined as determinants were used to establish a venous status score. The data were then repeated by analyzing the success rate as a function of the scale score. A clear link between score and risk of failure was established. It seems worthwhile to evaluate the impact of implementing this scale prior to the placement of a peripheral venous line. The hypothesis is that obtaining a score predictive of failure would modify the therapeutic attitude of the registered nurse. They would opt for techniques that would increase their chances of success. This in turn would lead to a reduction in unsuccessful attempts, which generate pain and anxiety for the patient. Preserving venous capital by increasing first-attempt success is both a health issue for the patient and a guarantee of quality of care.

Interventions

  • Procedure Training in the A-DIVA scale and its failure prediction score
    Nurses are trained in the A-DIVA scale and its predictive failure score. This score enables them to adapt their approach to peripheral venous line insertion.

Primary outcome measures

  • Success rate of peripheral venous vein placement [Time frame: 1 year]
Secondary outcome measures (5)
  • Total number of attempts [Time frame: 1 year]
  • Number of visualization techniques, alternative devices and/or third-party assistance used [Time frame: 1 year]
  • Pain score: Numerical Pain Scale [Time frame: 1 year]
  • Number of years' experience of nurses since obtaining diploma in nursing [Time frame: 1 year]
  • A-DIVA scale score [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Male or female patient of legal age included in a care program requiring a VVP;
  • Fluency in French
  • Patient affiliated to a social security scheme;
  • Written, signed and dated informed consent.

Exclusion criteria

  • As the A-DIVA scale specifies a search for venous access to the upper limb, any patient without an upper limb or with a condition that contraindicates VVP placement in the upper limbs will be excluded;
  • Patients treated as emergencies;
  • Patients with a language barrier or known significant cognitive or psychiatric disorders;
  • Patients under guardianship, curatorship, deprivation of liberty or legal protection;
  • Pregnant or breast-feeding women.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Other

Study locations

France · 3 centers
  • CHU Gabriel Montpied — Clermont-Ferrand
  • Centre Jean PERRIN — Clermont-Ferrand
  • Hôpital de la Croix Rousse — Lyon

Identifiers

NCT: NCT06062199 · 2023-A01480-45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗