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

Sponsor
Centre Jean Perrin (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06062199
Collaborator
(none)
200
2
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Training in the A-DIVA scale and its failure prediction score
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Impact of Implementing the Modified A-DIVA Scale on Successful Access to a Venous Line on the First Attempt
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control arm

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

Experimental: Experimental arm

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
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.

Outcome Measures

Primary Outcome Measures

  1. Success rate of peripheral venous vein placement [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.

Secondary Outcome Measures

  1. Total number of attempts [1 year]

    Total number of attempts

  2. Number of visualization techniques, alternative devices and/or third-party assistance used [1 year]

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

  3. Pain score: Numerical Pain Scale [1 year]

    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.

  4. Number of years' experience of nurses since obtaining diploma in nursing [1 year]

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

  5. A-DIVA scale score [1 year]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Centre Jean Perrin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Jean Perrin
ClinicalTrials.gov Identifier:
NCT06062199
Other Study ID Numbers:
  • 2023-A01480-45
First Posted:
Oct 2, 2023
Last Update Posted:
Oct 3, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 3, 2023