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NCT Number: 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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients requiring placement of a long peripheral venous catheter.
  • Patients who have provided written informed consent.
  • Patients with an expected hospital stay of ≥7 days.

Exclusion criteria

  • Inability to place a long peripheral venous catheter in the upper limbs.

Treatment and study plan

Needle-free connector with neutral fluid displacement and without anti-reflux technology

Procedure

Placement of a needle-free connector with neutral fluid displacement and no anti-reflux technology onto a long PVC.

Needle-free connector with neutral fluid displacement and equipped with anti-reflux technology

Procedure

Placement of a needle-free connector featuring neutral fluid displacement and anti-reflux technology onto a long PVC.

Long peripheral venous catheter

Device

Placement of a 20-gauge long PVC in an arm vein using the AST.

Ultrasound scanner

Other

All punctures will be performed under ultrasound guidance.

Primary outcomes

  1. Number of participants who experienced device-related adverse events, classified according to CTCAE v5.0.

    Time frame: 7 days

    Percentage of participants experiencing adverse events following insertion of a long peripheral venous catheter and placement of a needle-free connector featuring neutral fluid displacement and anti-reflux technology (Clave™ Neutron™, Ref. 011-NC139).

Secondary outcomes

  1. Number of participants with partial or complete occlusions in long peripheral venous catheters, as assessed using the CINAS scale (UZ Leuven®).

    Time frame: 7 days

    To determine the total number of partial and complete occlusions in long peripheral venous catheters in adult inpatients during the acute phase of illness within the first seven days after insertion of either a needle-free connector featuring neutral fluid displacement and anti-reflux technology (Clave™ Neutron™) or a neutral connector without this technology.

Study contacts

Contact information is provided by the study sponsor or research team.

Padilla-Nula F PhD candidate, Nurse

CONTACT

[email protected]

+ 34 973 24 81 00 ext. 8 4169

Sponsors and collaborators

Lead sponsor

Hospital Arnau de Vilanova

Other

Collaborators

  • Department of Health, Generalitat de Catalunya (PERIS)
  • Official College of Nurses of Lleida

Registry information

Acronym: FLUSH-ETI

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2026
Registry last updated
Apr 16, 2026

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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