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

Primary Purpose

Chronic Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Training in the A-DIVA scale and its failure prediction score
Sponsored by
Centre Jean Perrin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control arm

    Experimental arm

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Total number of attempts
    Total number of attempts
    Number of visualization techniques, alternative devices and/or third-party assistance used
    Number of visualization techniques, alternative devices and/or third-party assistance used
    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.
    Number of years' experience of nurses since obtaining diploma in nursing
    Number of years' experience of nurses since obtaining diploma in nursing
    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.

    Full Information

    First Posted
    September 25, 2023
    Last Updated
    October 2, 2023
    Sponsor
    Centre Jean Perrin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06062199
    Brief Title
    Impact of Implementing the Modified A-DIVA Scale on Successful Access to a Venous Line on the First Attempt
    Acronym
    DIVAPERF
    Official Title
    Impact of Implementing the Modified A-DIVA Scale on Successful Access to a Venous Line on the First Attempt
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    November 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Jean Perrin

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Disease

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control arm
    Arm Type
    No Intervention
    Arm Description
    Nurses will place a peripheral venous line on these patients without having been trained in the venous status score predictive of failure.
    Arm Title
    Experimental arm
    Arm Type
    Experimental
    Arm Description
    Nurses will place a peripheral venous line on these patients after being trained in the venous status score predictive of failure.
    Intervention Type
    Procedure
    Intervention Name(s)
    Training in the A-DIVA scale and its failure prediction score
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Success rate of peripheral venous vein placement
    Description
    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.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Total number of attempts
    Description
    Total number of attempts
    Time Frame
    1 year
    Title
    Number of visualization techniques, alternative devices and/or third-party assistance used
    Description
    Number of visualization techniques, alternative devices and/or third-party assistance used
    Time Frame
    1 year
    Title
    Pain score: Numerical Pain Scale
    Description
    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.
    Time Frame
    1 year
    Title
    Number of years' experience of nurses since obtaining diploma in nursing
    Description
    Number of years' experience of nurses since obtaining diploma in nursing
    Time Frame
    1 year
    Title
    A-DIVA scale score
    Description
    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.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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