Evaluation of A-DIVA Score Effectiveness at Admission for Preserving Venous Capital in Patients With Difficult Access

NCT ID: NCT06952829

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-21

Study Completion Date

2028-09-30

Brief Summary

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In certain cases (e.g.: patient who are difficult to perfuse, thin veins, etc.), an increase in venipunctures performed by study nurses in healthcare services can lead to a loss of venous capital, repeated pain during punctures, discontinuous treatment follow-up and numerous requests for assistance from colleagues, including nurse anesthetists, but often too late.

The main objective of project is to reduce the number of punctures to access the venous system after evaluation of adult patients upon entering the hospitalization department using the A-DIVA tool. the A-DIVA score predicts the difficulty in infusing an adult patient

Detailed Description

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This research evaluates the importance of assessing the venous capital access of hospitalized patients prior to the placement of an intravenous infusion, in order to save time in initiating therapeutic treatment and to prevent or reduce the number of venipunctures and the associated inconveniences (pain, discontinuous treatment monitoring). This approach aims to preserve the patient's venous capital.

In the proposed study, investigators will evaluate the patients' venous capital using the Adult-Difficult IntraVenous Access (A-DIVA) tool upon hospital admission and during hospitalization before any peripheral intravenous (IV) catheter placement.

During the inclusion visit, after obtaining informed consent, patients will be randomized into one of two groups:

* Group A: Patients will undergo an evaluation of their venous capital by a study nurse using the Adult-Difficult IntraVenous Access (A-DIVA) tool prior to any peripheral IV catheter placement during hospitalization.
* Group B: Patients will not undergo an evaluation of their venous capital using the Adult-Difficult IntraVenous Access (A-DIVA) tool prior to peripheral IV catheter placement. They will receive standard care as routinely provided in the hospital ward.

Conditions

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Internal Medicine Surgery Neurology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

controlled, randomized study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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with Adult-Difficult IntraVenous Access (A-DIVA) and with A-DIVA modified score evaluation

intravenous access of these patients will be evaluated by the ADIVA and with modified ADIVA (ADIVA m) scores before puncture by the nurse

Group Type EXPERIMENTAL

evaluation of intravenous access of patients with Adult-Difficult IntraVenous Access (A-DIVA) score prior to puncturing subject

Intervention Type OTHER

The patient's intravenous access will be evaluated using the A-DIVA score by the study nurse at the time of admission, prior to venipuncture performed by the care nurse

evaluation of intravenous access of patients with modified Adult-Difficult IntraVenous access(A-DIVA modified) score prior to puncturing subject

Intervention Type OTHER

The patient's intravenous access will be evaluated using the A-DIVA-m score by the study nurse at the time of admission, prior to venipuncture performed by the care nurse

without Adult-Difficult IntraVenous Access (A-DIVA) score evaluation

control group, patients will not undergo an evaluation of their intravenous access using the Adult-Difficult IntraVenous Access (A-DIVA) tool prior to peripheral IV catheter placement. They will receive standard care as routinely provided in the hospital.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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evaluation of intravenous access of patients with Adult-Difficult IntraVenous Access (A-DIVA) score prior to puncturing subject

The patient's intravenous access will be evaluated using the A-DIVA score by the study nurse at the time of admission, prior to venipuncture performed by the care nurse

Intervention Type OTHER

evaluation of intravenous access of patients with modified Adult-Difficult IntraVenous access(A-DIVA modified) score prior to puncturing subject

The patient's intravenous access will be evaluated using the A-DIVA-m score by the study nurse at the time of admission, prior to venipuncture performed by the care nurse

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male and Female Adult Patients Aged 18 Years and Older
* written informed consent given by patient
* Affiliation to a social security system or equivalence system

Exclusion Criteria

* Patients in Intensive Care Units
* Patients with Psychiatric Disorders or Under Psychiatric Care
* Minor Patients Under 18 Years of Age
* Pregnant or Breastfeeding Women
* Vulnerable and Protected Individuals as Defined by the Public Health Code (Articles L.1121-5 to L.1121-8 and L.1122-1-2)
* Patients Participating in Another Interventional Study
* Dying patients
* Patients Receiving Infusions of:

* Chemotherapy Drugs with a pH \<5 or \>8
* Solutions with an Osmolarity \>900 mOsm/L
* Patients refusing to participate in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Intercommunal Robert Ballanger

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric MORTUREUX, IADE

Role: PRINCIPAL_INVESTIGATOR

CH BALLANGER

Locations

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CHI Robert Ballanger

Aulnay-sous-Bois, , France

Site Status

Countries

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France

Central Contacts

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Eric MORTUREUX, PI

Role: CONTACT

01 49 36 70 41

Facility Contacts

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Nour BEKOUCHE

Role: primary

0141708631

References

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Yen K, Riegert A, Gorelick MH. Derivation of the DIVA score: a clinical prediction rule for the identification of children with difficult intravenous access. Pediatr Emerg Care. 2008 Mar;24(3):143-7. doi: 10.1097/PEC.0b013e3181666f32.

Reference Type BACKGROUND
PMID: 18347490 (View on PubMed)

Heydinger G, Shafy SZ, O'Connor C, Nafiu O, Tobias JD, Beltran RJ. Characterization of the Difficult Peripheral IV in the Perioperative Setting: A Prospective, Observational Study of Intravenous Access for Pediatric Patients Undergoing Anesthesia. Pediatric Health Med Ther. 2022 May 4;13:155-163. doi: 10.2147/PHMT.S358250. eCollection 2022.

Reference Type BACKGROUND
PMID: 35548373 (View on PubMed)

van Loon FHJ, van Hooff LWE, de Boer HD, Koopman SSHA, Buise MP, Korsten HHM, Dierick-van Daele ATM, Bouwman ARA. The Modified A-DIVA Scale as a Predictive Tool for Prospective Identification of Adult Patients at Risk of a Difficult Intravenous Access: A Multicenter Validation Study. J Clin Med. 2019 Jan 26;8(2):144. doi: 10.3390/jcm8020144.

Reference Type BACKGROUND
PMID: 30691137 (View on PubMed)

Other Identifiers

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GHT_CHIRB_20240618

Identifier Type: -

Identifier Source: org_study_id

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