Using the Accuvein Device for Patients Who Are Difficult to Perfuse (VAV-AV)

Prior to any examination related to the clinical investigation, the investigator (IDE) will check the eligibility criteria of the person undergoing the research, and will inform and obtain the free, informed and written consent of the person undergoing the research.

The patient will then be randomised into one of two groups (insertion of a intravenous route with the AccuVein device vs. insertion of a VVP without the AccuVein device). After randomisation, the TEC or qualified person starts the stopwatch as soon as the tourniquet is applied.

The nurse makes a first attempt to perfuse the patient. The TEC or the qualified person will stop the stopwatch when the nurse checks the patency of the first attempt at perfusion and signals its success, or when the nurse withdraws the needle if the first attempt is unsuccessful. The pain felt by the patient will be assessed by the nurse using the self-assessment scale from 0 to 10 at the end of the first attempt.

If the first attempt at VVP insertion fails, the choice of conditions and personnel involved in carrying out further attempts will be left to the discretion of the nurse.

Study Overview

• Status: Not yet recruiting
• Conditions: Patient Who Are Difficult to Infuse
• Intervention / Treatment: Device: accuvein; Other: with out accuvein

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: déborah lebedieff; Phone Number: 0232888265; Email: deborah.lebedieff@chu-rouen.fr
• Study Contact Backup: Name: jessica bortzmeyer, nurse; Phone Number: 02 32 88 86 94; Email: jessica.bortzmeyer@chu-rouen.fr

Study Locations

• France
  • Rouen
    • Rouen, Rouen, France, 76 031
      • CHU Rouen
      • Contact: jessica bortzmeyer, nurse; Phone Number: 02 32 88 86 94; Email: jessica.bortzmeyer@chu-rouen.fr
      • Principal Investigator: jessica bortzmeyer, nurse

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age ≥ 18 years
• Patients who are difficult to infuse according to the nurse's subjective assessment after the tourniquet has been applied; this may particularly concern patients who are obese, dark-skinned, multi-drug users, sickle-cell anaemia sufferers, drug addicts, elderly with fragile skin and subcutaneous haematomas
• Patients with a medical prescription for intravenous route
• Patients affiliated to a social security scheme
• For women of childbearing age: effective contraception (oral contraceptives, intra-uterine devices or condoms) or post-menopausal women (no menstrual period for 12 months).
• Patient has read and understood the information letter and signed the consent form

Exclusion Criteria:

• Contraindication to fitting a intravenous route (burns to all four limbs, etc.)
• Extreme urgency to have a intravenous route, incompatible with the study, because of a loss of chance due to loss of time
• Patients unable to consent to participation in research
• Pregnant or breastfeeding women or women in labour
• Person deprived of liberty by administrative or judicial decision or person placed under court protection/guardianship or curatorship

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: accuvein	Device: accuvein; intravenous route with accuvein
Other: with out accuvein	Other: with out accuvein; intravenous route with out accuvein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Successful first attempt at intravenous route insertion defined by a functional perfusion placed in a vein	day 1

Collaborators and Investigators

• Sponsor: University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: February 28, 2025
• First Posted (Actual): March 6, 2025

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2022/0357/HP

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