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

Chronic Disease Clinical Trial

— DIVAPERF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06062199
• Other study ID #: 2023-A01480-45
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2024
• Est. completion date: November 2024

Study information

• Verified date: February 2024
• Source: Centre Jean Perrin
• Contact: Judith PASSILDAS JAHANMOHAN, PhD
• Phone: +33473278005
• Email: judith.passildas[@]clermont.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease

Intervention

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.

Locations

Country	Name	City	State
France	Centre Jean PERRIN	Clermont-Ferrand
France	CHU Gabriel Montpied	Clermont-Ferrand
France	Hôpital de la Croix Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Jean Perrin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total number of attempts	Total number of attempts	1 year
Secondary	Number of visualization techniques, alternative devices and/or third-party assistance used	Number of visualization techniques, alternative devices and/or third-party assistance used	1 year
Secondary	Pain score: Numerical Pain Scale	The pain score is based on a numerical pain scale ranging from 0 to 10, with 0 representing no pain and 10 representing unbearable pain.	1 year
Secondary	Number of years' experience of nurses since obtaining diploma in nursing	Number of years' experience of nurses since obtaining diploma in nursing	1 year
Secondary	A-DIVA scale score	The A-DIVA score (Adult Difficult Intravenous Access Score) predicts the difficulty of infusing an adult. The score ranges from 0 to 5, with 0 being the lowest risk of difficulty, and 5 being the highest.	1 year