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NCT Number: NCT06838364

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Poitiers Hospital

Poitiers, 86000, France

Location status: Recruiting

Location contact

Guillaume DAVY

CONTACT

[email protected]

516604285 ext. 33

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Infrared peripheral venous technique

Other

use a infrared device for venous peripheral visualisation and catheter insertion

Other names: 2

Ultrasound-guided peripheral venous technique

Other

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

Other names: 1

Landmark technique

Other

the gold standard technique with observationnal and palpation

Other names: control

Primary outcomes

  1. The proportion of patients with a successful catheterization at the first attempt

    Time frame: Up to 4 hours

    Success 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 outcomes

  1. Proportion of patients with successful cathetherization at the second attempt (in case of failure of the first attempt)

    Time frame: Up to 4 hours

    Success 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)

  2. The number of attempts

    Time frame: Up to 4 hours

    The number of attempts will be assessed by the number of breach of the skin barrier by a catheter

  3. The maximum pain felt by the patient during the attempts

    Time frame: Up to 4 hours

    Maximum pain will be assessed using a numerical rating scale ranging from 0 to 10. Higher score stands for a better outcome.

  4. Overall satisfaction of the patient

    Time frame: Up to 4 hours

    Satisfaction will be assessed using a numerical rating scale ranging from 0 to 10. Higher score stands for a better outcome.

  5. Overall satisfaction of the caregiver

    Time frame: Up to 4 hours

    Satisfaction will be assessed using a numerical rating scale ranging from 0 to 10. Higher score stands for a better outcome.

  6. Time-to-catheterisation

    Time frame: Up to 4 hours

    Time from the end of material preparation to a successful catheterisation.

  7. Description of the rescue technique after 2 failures

    Time frame: Up to 4 hours

    Rescue 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).

  8. Catheter size used for the successful catheterisation

    Time frame: Up to 4 hours

    Catheter sizes chosen by carers

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume DAVY, Master

CONTACT

[email protected]

+33516604285

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Acronym: REUSSIR-VVP

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 20, 2025
Registry last updated
Sep 1, 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.

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