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

Randomized Controlled Clinical Trial Assessing the Effectiveness of a Venipuncture Strategy Adapted According to A-DIVA Score Results Compared to Standard Care in Reducing the Number of Punctures

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

Study Overview

• Status: Not yet recruiting
• Conditions: Surgery; Neurology; Internal Medicine
• Intervention / Treatment: Other: evaluation of intravenous access of patients with Adult-Difficult IntraVenous Access (A-DIVA) score prior to puncturing subject; Other: evaluation of intravenous access of patients with modified Adult-Difficult IntraVenous access(A-DIVA modified) score prior to puncturing subject

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric MORTUREUX, PI; Phone Number: 01 49 36 70 41; Email: eric.mortureux@ght-gpne.fr

Study Locations

• France
  • Aulnay-sous-Bois, France, 93602
    • CHI Robert Ballanger
    • Contact: Nour BEKOUCHE; Phone Number: 0141708631; Email: nour.bekouche@ght-gpne.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 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; 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
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Venipunctures Performed to Establish the First Peripheral Intravenous Line in the Hospital services	Number of Venipunctures Performed to Establish the First Peripheral Intravenous Line in the Hospital services	Periprocedural Venipuncture performed by study nurse from Day 0 (date of admission to hospital service) to Day 10 or until hospital discharge subject

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain score (numeric rating scale) during venipuncture	assess the patient's pain on a scale of 0 to 10 at the time of the puncture. A lower score indicates less painful, a higher score means that patient is more painful.	During venipuncture from Day 0 to Day 10 or throughout the entire hospitalization period
duration of successful catheter placement	duration of successful catheter placement	During catheter placement from Day 0 to Day 10 or throughout the entire hospitalization period

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Robert Ballanger
• Investigators: Principal Investigator: Eric MORTUREUX, IADE, CH BALLANGER

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 21, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: April 28, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Adult-Difficult IntraVenous Access (A-DIVA); capital venous preservation
• Other Study ID Numbers: GHT_CHIRB_20240618

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No