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 (REUSSIR-VVP)

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Venous Catheterization
• Intervention / Treatment: Other: Landmark technique; Other: Infrared peripheral venous technique; Other: Ultrasound-guided peripheral venous technique

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.

• Study Type: Interventional
• Enrollment (Estimated): 264
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guillaume DAVY, Master; Phone Number: +33516604285; Email: guillaume.davy@chu-poitiers.fr

Study Locations

• France
  • Poitiers, France, 86000
    • Recruiting
    • Poitiers Hospital
    • Contact: Guillaume DAVY; Phone Number: 33 516604285; Email: guillaume.davy@chu-poitiers.fr

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Infrared peripheral venous technique; use an infrared device for venous peripheral visualisation and catheter insertion	Other: Infrared peripheral venous technique; use a infrared device for venous peripheral visualisation and catheter insertion; Other Names: 2
Active Comparator: Ultrasound-guided peripheral venous technique; Use the Ultrasound-guided technique for venous peripheral visualisation and catheter insertion	Other: Ultrasound-guided peripheral venous technique; Use the ultrasound-guided technique for venous peripheral visualisation and catheter insertion; Other Names: 1
Active Comparator: Standard technique; The gold standard technique, with observationnal and palpation	Other: Landmark technique; the gold standard technique with observationnal and palpation; Other Names: control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients with a successful catheterization at the first attempt	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)	Up to 4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with successful cathetherization at the second attempt (in case of failure of the first attempt)	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)	Up to 4 hours
The number of attempts	The number of attempts will be assessed by the number of breach of the skin barrier by a catheter	Up to 4 hours
The maximum pain felt by the patient during the attempts	Maximum pain will be assessed using a numerical rating scale ranging from 0 to 10. Higher score stands for a better outcome.	Up to 4 hours
Overall satisfaction of the patient	Satisfaction will be assessed using a numerical rating scale ranging from 0 to 10. Higher score stands for a better outcome.	Up to 4 hours
Overall satisfaction of the caregiver	Satisfaction will be assessed using a numerical rating scale ranging from 0 to 10. Higher score stands for a better outcome.	Up to 4 hours
Time-to-catheterisation	Time from the end of material preparation to a successful catheterisation.	Up to 4 hours
Description of the rescue technique after 2 failures	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).	Up to 4 hours
Catheter size used for the successful catheterisation	Catheter sizes chosen by carers	Up to 4 hours

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2025
• Primary Completion (Estimated): April 8, 2028
• Study Completion (Estimated): April 8, 2028

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): February 20, 2025

Study Record Updates

• Last Update Posted (Actual): September 1, 2026
• Last Update Submitted That Met QC Criteria: August 27, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: ultrasound guided; infrared; A-DIVA scale
• Other Study ID Numbers: REUSSIR-VVP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No