Chu Rouen
Rouen, 76 031, France
Location contact
jessica bortzmeyer, nurse
CONTACT
jessica bortzmeyer, nurse
PRINCIPAL_INVESTIGATOR
Not Yet Recruiting
NCT Number: NCT06861595
Using the Accuvein Device for Patients Who Are Difficult to Perfuse
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
accuvein
Deviceintravenous route with accuvein
with out accuvein
Otherintravenous route with out accuvein
Primary outcomes
-
Successful first attempt at intravenous route insertion defined by a functional perfusion placed in a vein
Time frame: day 1
Study contacts
Contact information is provided by the study sponsor or research team.
déborah lebedieff
CONTACT
jessica bortzmeyer, nurse
CONTACT
Sponsors and collaborators
Lead sponsor
University Hospital, Rouen
Other
Registry information
Acronym: VAV-AV
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Mar 6, 2025
- Registry last updated
- Feb 20, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.