Peripheral Venous Catheterization
Conditions
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
use a infrared device for venous peripheral visualisation and catheter insertion
Use the ultrasound-guided technique for venous peripheral visualisation and catheter insertion
the gold standard technique with observationnal and palpation
Sponsors
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients with a successful catheterization at the first attempt | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall satisfaction of the patient | 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. |
| Overall satisfaction of the caregiver | 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. |
| Time-to-catheterisation | Up to 4 hours | Time from the end of material preparation to a successful catheterisation. |
| Description of the rescue technique after 2 failures | 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). |
| Catheter size used for the successful catheterisation | Up to 4 hours | Catheter sizes chosen by carers |
| The number of attempts | Up to 4 hours | The 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 attempts | 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. |
| Proportion of patients with successful cathetherization at the second attempt (in case of failure of the first attempt) | 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) |
Countries
France