Chronic DiseaseDIVAPERFNCT06062199
Impact of Implementing the Modified A-DIVA Scale on Successful Access to a Venous Line on the First Attempt
A study testing Training in the A-DIVA scale and its failure prediction score in people with Chronic Disease, run by Centre Jean Perrin at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Training in the A-DIVA scale and its failure prediction score
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesFrance
- Study dates
- 27 Feb 2024to 17 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Gabriel Montpied
Clermont-Ferrand, 63000
Centre Jean PERRIN
Clermont-Ferrand, 63011
Hôpital de la Croix Rousse
Lyon, 69004
About this study
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
- Being tested
- Training in the A-DIVA scale and its failure prediction score
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training in the A-DIVA scale and its failure prediction scoreProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Training in the A-DIVA scale and its failure prediction score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (5)
Total number of attempts
Total number of attempts
Measured: 1 year
Number of visualization techniques, alternative devices and/or third-party assistance used
Number of visualization techniques, alternative devices and/or third-party assistance used
Measured: 1 year
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.
Measured: 1 year
Number of years' experience of nurses since obtaining diploma in nursing
Number of years' experience of nurses since obtaining diploma in nursing
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start27 Feb 2024
- Primary completion17 Sep 2026
- Study completion17 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucie MADELAINE, Study director, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062199
- Sponsor's protocol ID
- 2023-A01480-45
- Acronym
- DIVAPERF
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2023
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Godiveau M, Passildas Jahanmohan J, Casile M, Thivat E, Giro A, Pinard C, Molnar I, Jacquet C, Courty ML, Decombe F, Laurent H, Bourg MA, Abrial C, Durando X, Madelaine L. Impact of Implementing the Modified Assessment of the Difficulty of Intravenous Access Scale on First-Attempt Venous Access Success: Study Protocol for the Multicenter Prospective Before-and-After Controlled DIVAPERF Trial. Health Sci Rep. 2026 Oct 8;9(10):e73266. doi: 10.1002/hsr2.73266. eCollection 2026 Oct.
PubMed 42857443
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Implementing the Modified A-DIVA Scale on Successful Access to a Venous Line on the First Attempt
- ClinicalTrials.gov ID
- NCT06062199
- Acronym / sponsor ID
- DIVAPERF / 2023-A01480-45
- Conditions
- Chronic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 17 Sep 2026 (actual)
- Study completion
- 17 Sep 2026 (actual)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: Training in the A-DIVA scale and its failure prediction scoreNurses will place a peripheral venous line on these patients after being trained in the venous status score predictive of failure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training in the A-DIVA scale and its failure prediction scoreNurses 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. | Procedure or surgery | Experimental arm |
Primary outcome
Success rate of peripheral venous vein placement
Time frame: 1 year
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.
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Derived from this study: PubMed 42857443Godiveau M, Passildas Jahanmohan J, Casile M, Thivat E, Giro A, Pinard C, Molnar I, Jacquet C, Courty ML, Decombe F, Laurent H, Bourg MA, Abrial C, Durando X, Madelaine L. Impact of Implementing the Modified Assessment of the Difficulty of Intravenous Access Scale on First-Attempt Venous Access Success: Study Protocol for the Multicenter Prospective Before-and-After Controlled DIVAPERF Trial. Health Sci Rep. 2026 Oct 8;9(10):e73266. doi: 10.1002/hsr2.73266. eCollection 2026 Oct.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucie MADELAINE study director
Centre Jean Perrin
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in the A-DIVA scale and its failure prediction score in people with Chronic Disease, run by Centre Jean Perrin at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of peripheral venous vein placement (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06062199, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.