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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Needle-free connector with neutral fluid displacement and without anti-reflux technology, Needle-free connector with neutral fluid displacement and equipped with anti-reflux technology, Long peripheral venous catheter, Ultrasound scanner.
- Who it may be relevant to
- Registry conditions: Vascular Access Devices, Catheters, Occlusion, Thrombosis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Number of participants who experienced device-related adverse events, classified according to CTCAE v5.0. [Time frame: 7 days]
Secondary outcome measures (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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Krath J, Fredskilde J, Christensen SK, Baltsen CD, Valentin K, Offersen R, Juhl-Olsen P. The performance and complications of long peripheral venous catheters: A retrospective single-centre study. Acta Anaesthesiol Scand. 2024 Nov;68(10):1463-1470. doi: 10.1111/aas.14517. Epub 2024 Aug 26. PMID 39183695
- Goossens GA, De Waele Y, Jerome M, Fieuws S, Janssens C, Stas M, Moons P. Diagnostic accuracy of the Catheter Injection and Aspiration (CINAS) classification for assessing the function of totally implantable venous access devices. Support Care Cancer. 2016 Feb;24(2):755-761. doi: 10.1007/s00520-015-2839-x. Epub 2015 Jul 26. PMID 26209949
- U.S. Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE) v.5.0. Cancer Ther Eval Progr [Internet]. 2017;155. Available from: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcae_v5_quick_reference_5x7.pdf
- Schulz KF, Altman DG, Moher D; Consort Group. [CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials (Chinese version)]. Zhong Xi Yi Jie He Xue Bao. 2010 Jul;8(7):604-12. doi: 10.3736/jcim20100702. Chinese. PMID 20619135
- Valentino R, Farkas V. Maximizing the Midline [Internet]. AVA. 2015 [cited 2025 Jul 16]. p. 1. Available from: https://nexusmedical.com/wp-content/uploads/2021/04/nexus-medical-poster-25-valentino-farkas-maximizing-the-midline-new-york-methodist-hospital-2015-ava-national-conference.pdf
- ICU medical. Observational In-Vivo Evaluation of the NeutronTM Needlefree Catheter Patency Device and its Effects on Catheter Occlusions in a Home Care Setting [Internet]. icumed.com; 2011. p. 1-2. Available from: https://www.icumed.com/media/ddqd4cgy/p23-5809_neutron-catheter-patency-and-occlusions-home-care-setting_web.pdf
- Moureau N, Gorski L, Flynn J, Johnson K. A Systematic Review of Needleless Connector Function and Occlusion Outcomes: Evidence Leading the Way. J Infus Nurs. 2025 Mar-Apr 01;48(2):84-105. doi: 10.1097/NAN.0000000000000578. Epub 2025 Mar 6. PMID 40047605
- Nexus medical. Nexus TKO® Technology [Internet]. nexusmedical.com. 2022 [cited 2025 Jul 16]. p. 1-10. Available from: https://nexusmedical.com/tko-technology/
Identifiers
NCT: NCT07519304 · 04/25