Needle-free connector with neutral fluid displacement and without anti-reflux technology
ProcedurePlacement of a needle-free connector with neutral fluid displacement and no anti-reflux technology onto a long PVC.
NCT Number: NCT07519304
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.
Trial opening soon.
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Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Placement of a needle-free connector with neutral fluid displacement and no anti-reflux technology onto a long PVC.
Placement of a needle-free connector featuring neutral fluid displacement and anti-reflux technology onto a long PVC.
Placement of a 20-gauge long PVC in an arm vein using the AST.
All punctures will be performed under ultrasound guidance.
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).
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.
Contact information is provided by the study sponsor or research team.
Hospital Arnau de Vilanova
Other
Acronym: FLUSH-ETI
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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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