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NCT Number: NCT06952829

Evaluation of A-DIVA Score Effectiveness at Admission for Preserving Venous Capital in Patients With Difficult Access

In certain cases (e.g.: patient who are difficult to perfuse, thin veins, etc.), an increase in venipunctures performed by study nurses in healthcare services can lead to a loss of venous capital, repeated pain during punctures, discontinuous treatment follow-up and numerous requests for assistance from colleagues, including nurse anesthetists, but often too late.

The main objective of project is to reduce the number of punctures to access the venous system after evaluation of adult patients upon entering the hospitalization department using the A-DIVA tool. the A-DIVA score predicts the difficulty in infusing an adult patient

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Key information

Conditions

Internal Medicine Neurology Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This research evaluates the importance of assessing the venous capital access of hospitalized patients prior to the placement of an intravenous infusion, in order to save time in initiating therapeutic treatment and to prevent or reduce the number of venipunctures and the associated inconveniences (pain, discontinuous treatment monitoring). This approach aims to preserve the patient's venous capital.

In the proposed study, investigators will evaluate the patients' venous capital using the Adult-Difficult IntraVenous Access (A-DIVA) tool upon hospital admission and during hospitalization before any peripheral intravenous (IV) catheter placement.

During the inclusion visit, after obtaining informed consent, patients will be randomized into one of two groups:

  • Group A: Patients will undergo an evaluation of their venous capital by a study nurse using the Adult-Difficult IntraVenous Access (A-DIVA) tool prior to any peripheral IV catheter placement during hospitalization.
  • Group B: Patients will not undergo an evaluation of their venous capital using the Adult-Difficult IntraVenous Access (A-DIVA) tool prior to peripheral IV catheter placement. They will receive standard care as routinely provided in the hospital ward.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and Female Adult Patients Aged 18 Years and Older
  • written informed consent given by patient
  • Affiliation to a social security system or equivalence system

Exclusion criteria

  • Patients in Intensive Care Units
  • Patients with Psychiatric Disorders or Under Psychiatric Care
  • Minor Patients Under 18 Years of Age
  • Pregnant or Breastfeeding Women
  • Vulnerable and Protected Individuals as Defined by the Public Health Code (Articles L.1121-5 to L.1121-8 and L.1122-1-2)
  • Patients Participating in Another Interventional Study
  • Dying patients
  • Patients Receiving Infusions of:
  • Chemotherapy Drugs with a pH <5 or >8
  • Solutions with an Osmolarity >900 mOsm/L
  • Patients refusing to participate in the study

Treatment and study plan

evaluation of intravenous access of patients with Adult-Difficult IntraVenous Access (A-DIVA) score prior to puncturing subject

Other

The patient's intravenous access will be evaluated using the A-DIVA score by the study nurse at the time of admission, prior to venipuncture performed by the care nurse

evaluation of intravenous access of patients with modified Adult-Difficult IntraVenous access(A-DIVA modified) score prior to puncturing subject

Other

The patient's intravenous access will be evaluated using the A-DIVA-m score by the study nurse at the time of admission, prior to venipuncture performed by the care nurse

Primary outcomes

  1. Number of Venipunctures Performed to Establish the First Peripheral Intravenous Line in the Hospital services

    Time frame: Periprocedural Venipuncture performed by study nurse from Day 0 (date of admission to hospital service) to Day 10 or until hospital discharge subject

    Number of Venipunctures Performed to Establish the First Peripheral Intravenous Line in the Hospital services

Secondary outcomes

  1. pain score (numeric rating scale) during venipuncture

    Time frame: During venipuncture from Day 0 to Day 10 or throughout the entire hospitalization period

    assess the patient's pain on a scale of 0 to 10 at the time of the puncture. A lower score indicates less painful, a higher score means that patient is more painful.

  2. duration of successful catheter placement

    Time frame: During catheter placement from Day 0 to Day 10 or throughout the entire hospitalization period

    duration of successful catheter placement

Study contacts

Contact information is provided by the study sponsor or research team.

Eric MORTUREUX, PI

CONTACT

[email protected]

01 49 36 70 41

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Robert Ballanger

Other

Registry information

Official study title

Randomized Controlled Clinical Trial Assessing the Effectiveness of a Venipuncture Strategy Adapted According to A-DIVA Score Results Compared to Standard Care in Reducing the Number of Punctures

Acronym: ERV-ADIVA

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 1, 2025
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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