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

Not Applicable

Not yet recruiting

• Conditions: Internal Medicine; Surgery; Neurology

• Registration Number: NCT06952829
• Lead Sponsor: Centre Hospitalier Intercommunal Robert Ballanger

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-02-04
• Status Verified: 2025-04
• Study Start: 2025-04-21
• Study First Submitted QC: 2025-04-28
• Last Update Submitted: 2025-04-28
• Study First Posted: 2025-05-01
• Last Update Posted: 2025-05-01
• Primary Completion: 2028-03
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Venipunctures Performed to Establish the First Peripheral Intravenous Line in the Hospital services	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 Outcome Measures

Name	Time	Method
pain score (numeric rating scale) during venipuncture	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.
duration of successful catheter placement	During catheter placement from Day 0 to Day 10 or throughout the entire hospitalization period	duration of successful catheter placement

Trial Locations

Locations (1)

CHI Robert Ballanger; 🇫🇷 Aulnay-sous-Bois, France