Clinical trial NCT06952829: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Internal Medicine
Surgery
Neurology
Keywords: Adult-Difficult IntraVenous Access (A-DIVA)
capital venous preservation
Lead sponsor: Centre Hospitalier Intercommunal Robert Ballanger
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: controlled, randomized study
Primary purpose: OTHER

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

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.

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

Primary outcomes:
measure: Number of Venipunctures Performed to Establish the First Peripheral Intravenous Line in the Hospital services
timeFrame: 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:
measure: pain score (numeric rating scale) during venipuncture
timeFrame: During venipuncture from Day 0 to Day 10 or throughout the entire hospitalization period
measure: duration of successful catheter placement
timeFrame: During catheter placement from Day 0 to Day 10 or throughout the entire hospitalization period
Other outcomes:
Locations:
city: Aulnay-sous-Bois
country: France
facility: CHI Robert Ballanger
Study officials:
affiliation: CH BALLANGER
name: Eric MORTUREUX, IADE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.