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Comparison of the Effectiveness of Ultrasound-guided Techniques and Infrared Illumination, Compared With the Standard Approach to Peripheral Venous Line Placement in People With Difficult Venous Access

Comparison of the Effectiveness of Ultrasound-guided Techniques and Infrared Illumination, Compared With the Standard Approach to Peripheral Venous Line Placement in People With Difficult Venous Access

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06838364
Acronym
REUSSIR-VVP
Enrollment
264
Registered
2025-02-20
Start date
2025-04-08
Completion date
2028-04-08
Last updated
2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Venous Catheterization

Keywords

ultrasound guided, infrared, A-DIVA scale

Brief summary

Peripheral venous catheterization (PVC) is the most common invasive procedure in healthcare worldwide. Improving the success rate of PVC on the first attempt is crucial for patients, as it impacts pain, anxiety, the risk of extravasation, rapid access to care, and the patient-provider relationship. For healthcare providers, a higher success rate enhances self-confidence and autonomy, while institutions benefit from improved reputation and reduced costs. In the Poitiers hosptial, one in ten catheters is used in imaging services, with CT scan departments accounting for 66.3% of catheter usage due to iodinated contrast injections. Literature suggests two techniques to enhance PVC success: ultrasound-guided and infrared illumination methods. These techniques appear effective primarily for patients with difficult venous access. Additionally, the A-DIVA clinical score has been developed to predict first-attempt success rates. However, no studies in Europe have compared the effectiveness of these two techniques in imaging settings or based on the A-DIVA score. This study aims to identify the most effective technique for PVC in patients with difficult venous access.

Detailed description

This is a prospective, controlled, randomized, three-arm, single-center, superiority trial involving patients with difficult venous access. Control group: Classical method based on clinical examination (visualization and palpation). Experimental1 group: Ultrasound-guided method. Experimental2 group: Infrared illumination method. A total of 249 patients will be enrolled, with 82 patients in each group. The inclusion period will last 12 months, and each participant will be involved for a maximum of 4 hours. The total duration of the clinical investigation will be 1 year and 4 hours.

Interventions

OTHERInfrared peripheral venous technique

use a infrared device for venous peripheral visualisation and catheter insertion

OTHERUltrasound-guided peripheral venous technique

Use the ultrasound-guided technique for venous peripheral visualisation and catheter insertion

the gold standard technique with observationnal and palpation

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

This is a comparative, prospective, controlled, randomized trial with three parallel arms, conducted at a single center, with a superiority design, in patients with difficult venous access.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients aged 18 or over * Patient with a CT scan appointment and a medical prescription requiring a peripheral venous line. * Patient with an A-DIVA score greater than or equal to 2. * Patient able and willing to comply with all study procedures. * Patient covered by a social security scheme or covered through a third party. * Patients who have given their free and informed written consent following clear and fair information about the study.

Exclusion criteria

* Patient with a contraindication to VVP insertion: * Arm with arteriovenous fistula * Limb with an orthopaedic or vascular prosthesis * Previous mastectomy, axillary lymph node dissection or homolateral radiotherapy of the arm * Paralysed limb * Presence of haematomas or puncture site wounds * Limb with phlebitis or infection * Patients already included in the study * Persons benefiting from enhanced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, pregnant or breast-feeding women, adults under legal protection and patients in emergency situations.

Design outcomes

Primary

MeasureTime frameDescription
The proportion of patients with a successful catheterization at the first attemptUp to 4 hoursSuccess of the cathetherization is defined by a functional cathether without immediate complication : absence of pain expressed by the patient, or visible oedema (absence of signs of diffusion or haematoma)

Secondary

MeasureTime frameDescription
Overall satisfaction of the patientUp to 4 hoursSatisfaction will be assessed using a numerical rating scale ranging from 0 to 10. Higher score stands for a better outcome.
Overall satisfaction of the caregiverUp to 4 hoursSatisfaction will be assessed using a numerical rating scale ranging from 0 to 10. Higher score stands for a better outcome.
Time-to-catheterisationUp to 4 hoursTime from the end of material preparation to a successful catheterisation.
Description of the rescue technique after 2 failuresUp to 4 hoursRescue system chosen by the carer after 2 failures (call a colleague, continue with the conventional method, ultrasound-guided technique, infrared illumination technique or abandon peripheral venous insertion).
Catheter size used for the successful catheterisationUp to 4 hoursCatheter sizes chosen by carers
The number of attemptsUp to 4 hoursThe number of attempts will be assessed by the number of breach of the skin barrier by a catheter
The maximum pain felt by the patient during the attemptsUp to 4 hoursMaximum pain will be assessed using a numerical rating scale ranging from 0 to 10. Higher score stands for a better outcome.
Proportion of patients with successful cathetherization at the second attempt (in case of failure of the first attempt)Up to 4 hoursSuccess of the cathetherization is defined by a functional cathether without immediate complication : absence of pain expressed by the patient, or visible oedema (absence of signs of diffusion or haematoma)

Countries

France

Contacts

CONTACTGuillaume DAVY, Master
guillaume.davy@chu-poitiers.fr+33516604285

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026