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

NCT06952829 | Not Yet Recruiting

• 1 other identifier: GHT_CHIRB_20240618
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Internal Medicine; Surgery; Neurology

Keywords

Adult-Difficult IntraVenous Access (A-DIVA); capital venous preservation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• pain score (numeric rating scale) during venipuncture

  During venipuncture from Day 0 to Day 10 or throughout the entire hospitalization period

• duration of successful catheter placement

  During catheter placement from Day 0 to Day 10 or throughout the entire hospitalization period

Study Arms (2)

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

EXPERIMENTAL

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

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

NO INTERVENTION

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.

Interventions

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

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

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Robert Ballanger: lead

Study Sites (1)

CHI Robert Ballanger

Aulnay-sous-Bois, 93602, France

Location

Related Publications (3)

• 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.

  PMID: 18347490 BACKGROUND

• 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.

  PMID: 35548373 BACKGROUND

• 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.

  PMID: 30691137 BACKGROUND

Study Officials

• Eric MORTUREUX, IADE

  CH BALLANGER

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric MORTUREUX, PI

CONTACT

01 49 36 70 41; eric.mortureux@ght-gpne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: controlled, randomized study

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: May 1, 2025
• Study Start: April 21, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)