Poitiers Hospital
Poitiers, 86000, France
Location status: Recruiting
NCT Number: NCT06838364
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Poitiers, 86000, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
use a infrared device for venous peripheral visualisation and catheter insertion
Other names: 2
Use the ultrasound-guided technique for venous peripheral visualisation and catheter insertion
Other names: 1
the gold standard technique with observationnal and palpation
Other names: control
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)
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)
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
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.
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.
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.
Time frame: Up to 4 hours
Time from the end of material preparation to a successful catheterisation.
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).
Time frame: Up to 4 hours
Catheter sizes chosen by carers
Contact information is provided by the study sponsor or research team.
Poitiers University Hospital
Other
Acronym: REUSSIR-VVP
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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