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

NCT06838364 | Recruiting

• 1 other identifier: REUSSIR-VVP
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction 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. Objectives Compare the proportion of successful PVCs on the first attempt among the classical method (Gold Standard), ultrasound-guided technique, and infrared illumination technique in adult patients with difficult venous access. Compare the proportion of successful PVCs on the second attempt (if the first attempt fails) among the three techniques. Compare the total number of attempts required for successful PVC. Evaluate the maximum pain experienced by patients during successful PVC. Assess overall patient satisfaction following successful PVC. Evaluate operator satisfaction with the procedure. Measure the time taken for catheterization from material preparation to successful catheter placement. Analyze the fallback strategies chosen by operators after a failed attempt (e.g., calling a colleague, continuing with the classical method, using ultrasound guidance, infrared illumination, or abandoning the procedure). Describe the catheter sizes chosen by operators based on the A-DIVA score and the number of failed attempts. Methodology This is a prospective, controlled, randomized, three-arm, single-center, superiority trial involving patients with difficult venous access. Inclusion criteria include: Patients aged 18 years or older. Patients scheduled for a CT scan requiring PVC. Patients with an A-DIVA score of 2 or higher. Patients capable and willing to comply with study procedures. Patients covered by social security or through a third party. Patients providing written informed consent after receiving clear information about the study. Exclusion criteria include: Patients with contraindications for PVC (e.g., presence of an arteriovenous fistula, orthopedic or vascular prosthesis, history of mastectomy, etc.). Patients with contraindications for iodinated contrast injection as defined by the French Society of Radiology. Patients already included in the study. Vulnerable populations (e.g., minors, pregnant or breastfeeding women, individuals deprived of liberty). Intervention Groups Control: Classical method based on clinical examination (visualization and palpation). Experimental: Ultrasound-guided method. Experimental: Infrared illumination method. Sample Size and Duration 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. Outcome Measures The primary outcome is the proportion of successful PVCs on the first attempt, defined as the administration of 5 ml of NaCl without reported pain or visible edema. The total number of skin penetrations by the catheter will be recorded. Maximum pain will be assessed using a numerical rating scale (0-10). Patient satisfaction will be measured using a similar numerical scale. Operator satisfaction will also be evaluated on a scale from 0 (very dissatisfied) to 10 (very satisfied). Time for catheterization will be recorded in minutes, starting from the preparation of the PVC tray until successful catheter placement. The fallback strategy after a failed attempt will be documented. The size of the catheter chosen for each attempt will be recorded. Statistical Analysis The primary outcome will be compared among the three groups using ANOVA, followed by pairwise comparisons using Tukey's test if significant differences are found. Expected Outcomes Identifying the most effective PVC technique could increase the likelihood of first-attempt success in adults with difficult venous access. Benefits for Patients Reduced pain and discomfort from multiple attempts. Decreased risk of infection and extravasation. Maintenance of venous integrity. Sustained trust in the patient-provider relationship.

Conditions

Peripheral Venous Catheterization

Keywords

ultrasound guided; infrared; A-DIVA scale

Outcome Measures

Primary Outcomes (1)

• Evaluate the success of catheterization

  Absence of pain expressed by the patient, or visible oedema (absence of signs of diffusion or haematoma)

  Up to 4 hours

Secondary Outcomes (8)

• Evaluate the Success of catheterisation

  Up to 4 hours

• Evaluate the number of attempts

  Up to 4 hours

• Evaluate the maximum pain felt by the patient when the peripheral venous insertion is successfully inserted.

  Up to 4 hours

• Evaluate patient satisfaction

  Up to 4 hours

• Evaluate overall care giver satisfaction

  Up to 4 hours

Study Arms (3)

Landmark technique

ACTIVE COMPARATOR

The gold standard technique, with observationnal and palpation

Other: Landmark technique

Infrared peripheral venous technique

ACTIVE COMPARATOR

use an infrared device for venous peripheral visualisation and catheter insertion

Other: Infrared peripheral venous technique

Ultrasound-guided peripheral venous technique

ACTIVE COMPARATOR

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

Other: Ultrasound-guided peripheral venous technique

Interventions

Infrared peripheral venous technique OTHER

use a infrared device for venous peripheral visualisation and catheter insertion

Also known as: 2

Infrared peripheral venous technique

Landmark technique OTHER

the gold standard technique with observationnal and palpation

Also known as: control

Landmark technique

Ultrasound-guided peripheral venous technique OTHER

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

Also known as: 1

Ultrasound-guided peripheral venous technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

Poitiers Hospital

Poitiers, 86000, France

RECRUITING

Central Study Contacts

Guillaume g DAVY, Master

CONTACT

+33516604285; guillaume.davy@chu-poitiers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: February 20, 2025
• Study Start: April 8, 2025
• Primary Completion: April 8, 2026
• Study Completion: April 8, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

FR (1)