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

Official title

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

Overview

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

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.

Interventions

• 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

Primary outcome measures

• Number of Venipunctures Performed to Establish the First Peripheral Intravenous Line in the Hospital services [Time frame: 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 (2)

• pain score (numeric rating scale) during venipuncture [Time frame: During venipuncture from Day 0 to Day 10 or throughout the entire hospitalization period]
• duration of successful catheter placement [Time frame: During catheter placement from Day 0 to Day 10 or throughout the entire hospitalization period]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

France · 1 center

• CHI Robert Ballanger — Aulnay-sous-Bois

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. PMID 18347490
• 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
• 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

Identifiers

NCT: NCT06952829 · GHT_CHIRB_20240618

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗