Using the Accuvein Device for Patients Who Are Difficult to Perfuse
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: accuvein, with out accuvein.
- Who it may be relevant to
- Registry conditions: Patient Who Are Difficult to Infuse. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device accuvein
intravenous route with accuvein - Other with out accuvein
intravenous route with out accuvein
Primary outcome measures
- Successful first attempt at intravenous route insertion defined by a functional perfusion placed in a vein [Time frame: day 1]
Eligibility criteria
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
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
- Diagnostic
Study locations
France · 1 center
- Chu Rouen — Rouen
Identifiers
NCT: NCT06861595 · 2022/0357/HP