NCT07519304

Effectiveness of a Needle-free Connector With Anti-reflux Technology in Reducing Complications From Long Peripheral Venous Catheters in Hospitalised Adult Patients: Randomised Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Hospital Arnau de Vilanova · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

A study to evaluate a needle-free connector (a stopper) featuring anti-reflux technology (to prevent blood from flowing back) for catheters (polyurethane tubes inserted into a vein), with the aim of reducing complications associated with these devices: blockages, infections, pain, etc.

Detailed description

Introduction: Long peripheral venous catheters (PVCs) are a suitable alternative to short PVCs, midline catheters (MLCs) and central venous catheters (CVCs), particularly in patients with difficult intravenous access (DIVA), due to their characteristics: they are between 6 and 15 centimetres in length, have a gauge of 18 to 22 gauge (G), and do not extend beyond the axillary vein. Hypothesis: The use of a needle-free connector with neutral fluid displacement and equipped with anti-reflux technology (Clave™ Neutron™) in long PVCs in adult inpatients with acute conditions reduces the number of catheter failures during the first seven days compared with a neutral-displacement needle-free connector without an anti-reflux valve. Objective: To evaluate the efficacy of using a needle-free connector with neutral fluid displacement and equipped with anti-reflux technology (Clave™ Neutron™) following the insertion of long PVCs in adult inpatients in the acute phase of their illness during the first seven days. Methodology: A clinical study involving two randomised groups will be conducted prior to catheter placement. The control group will receive treatment using a needle-free connector with neutral fluid displacement and without an anti-reflux valve (Microclave® Clear, Ref. 011-MC3302). The intervention group will receive treatment using a needle-free connector with neutral fluid displacement and equipped with anti-reflux technology (Clave™ Neutron™, Ref. 011-NC139). Expected results: It is expected that the incidence of complications associated with long PVCs in hospitalised adult patients will be reduced following the standardised implementation of a needle-free connector with neutral fluid displacement and equipped with anti-reflux technology (Clave™ Neutron™) during the initial phase of treatment. Specifically, a reduction in the incidence of catheter obstructions and CRBSI is anticipated. Clinical implication: The study will contribute to optimising decision-making regarding catheter maintenance and related therapeutic measures, with the aim of reducing the main complications associated with them.

Conditions

• Vascular Access Devices
• Catheters
• Occlusion
• Thrombosis
• Randomised Controlled Trial

Interventions

Type	Name	Description
PROCEDURE	Needle-free connector with neutral fluid displacement and without anti-reflux technology	Placement of a needle-free connector with neutral fluid displacement and no anti-reflux technology onto a long PVC.
PROCEDURE	Needle-free connector with neutral fluid displacement and equipped with anti-reflux technology	Placement of a needle-free connector featuring neutral fluid displacement and anti-reflux technology onto a long PVC.
DEVICE	Long peripheral venous catheter	Placement of a 20-gauge long PVC in an arm vein using the AST.
OTHER	Ultrasound scanner	All punctures will be performed under ultrasound guidance.

Timeline

• Start date: 2026-04-20
• Primary completion: 2026-10-31
• Completion: 2026-12-31
• First posted: 2026-04-09
• Last updated: 2026-04-16