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

NCT06062199 | Recruiting

• 1 other identifier: 2023-A01480-45
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Chronic Disease

Outcome Measures

Primary Outcomes (1)

• Success rate of peripheral venous vein placement

  Success rate of peripheral venous vein insertion on the first attempt in the 2 groups (group in which VVP insertion will be performed by nurses not trained in the A-DIVA score and group in which VVP insertion will be performed after score assessment by nurses trained in the A-DIVA score) expressed by the number of attempts equal to 1.

  1 year

Secondary Outcomes (5)

• Total number of attempts

  1 year

• Number of visualization techniques, alternative devices and/or third-party assistance used

  1 year

• Pain score: Numerical Pain Scale

  1 year

• Number of years' experience of nurses since obtaining diploma in nursing

  1 year

• A-DIVA scale score

  1 year

Study Arms (2)

Control arm

NO INTERVENTION

Nurses will place a peripheral venous line on these patients without having been trained in the venous status score predictive of failure.

Experimental arm

EXPERIMENTAL

Nurses will place a peripheral venous line on these patients after being trained in the venous status score predictive of failure.

Procedure: Training in the A-DIVA scale and its failure prediction score

Interventions

Training in the A-DIVA scale and its failure prediction score PROCEDURE

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.

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Jean Perrin: lead

Study Sites (3)

CHU Gabriel Montpied

Clermont-Ferrand, 63000, France

NOT YET RECRUITING

Centre Jean PERRIN

Clermont-Ferrand, 63011, France

RECRUITING

Hôpital de la Croix Rousse

Lyon, 69004, France

NOT YET RECRUITING

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lucie MADELAINE

  Centre Jean Perrin

  STUDY DIRECTOR

Central Study Contacts

Judith PASSILDAS JAHANMOHAN, PhD

CONTACT

+33473278005; judith.passildas@clermont.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 2, 2023
• Study Start: February 27, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

FR (3)