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

NCT07519304 | Not Yet Recruiting DMC

• 1 other identifier: 04/25
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

Needleless connector

Outcome Measures

Primary Outcomes (1)

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

  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).

  7 days

Secondary Outcomes (1)

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

  7 days

Study Arms (2)

Needle-free connector without anti-reflux technology

ACTIVE COMPARATOR

Insertion of a long peripheral venous catheters (PVCs) using the accelerated Seldinger technique (AST), followed by placement of a needle-free connector with neutral fluid displacement and no anti-reflux technology (Microclave® Clear, Ref. 011-MC3302).

Procedure: Needle-free connector with neutral fluid displacement and without anti-reflux technology; Device: Long peripheral venous catheter; Other: Ultrasound scanner

Needle-free connector with anti-reflux technology

EXPERIMENTAL

Insertion of a long PVCs using the AST, followed by placement of a needle-free connector featuring neutral fluid displacement and anti-reflux technology (Clave™ Neutron™, Ref. 011-NC139).

Procedure: Needle-free connector with neutral fluid displacement and equipped with anti-reflux technology; Device: Long peripheral venous catheter; Other: Ultrasound scanner

Interventions

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 without anti-reflux technology

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.

Needle-free connector with anti-reflux technology

Long peripheral venous catheter DEVICE

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

Needle-free connector with anti-reflux technology; Needle-free connector without anti-reflux technology

Ultrasound scanner OTHER

All punctures will be performed under ultrasound guidance.

Needle-free connector with anti-reflux technology; Needle-free connector without anti-reflux technology

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Official College of Nurses of Lleida: collaborator
• Hospital Arnau de Vilanova: lead
• Department of Health, Generalitat de Catalunya (PERIS): collaborator

Related Publications (28)

• Krath J, Fredskilde J, Christensen SK, Baltsen CD, Valentin K, Offersen R, et al. The performance and complications of long peripheral venous catheters: A retrospective single-centre study. Acta Anaesthesiol Scand Scand [Internet]. 2024 Nov 26;68(10):1463-70. Available from: https://onlinelibrary.wiley.com/doi/10.1111/aas.14517

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• 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

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• 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

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• 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 [Internet]. 2025 Mar;48(2):84-105. Available from: https://journals.lww.com/10.1097/NAN.0000000000000578

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• Nexus medical. Nexus TKO® Technology [Internet]. nexusmedical.com. 2022 [cited 2025 Jul 16]. p. 1-10. Available from: https://nexusmedical.com/tko-technology/

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• ICU medical. ClaveTM NeutronTM: Anti-Reflux Neutral Displacement Needlefree Connector [Internet]. https://www.icumed.com/. 2025 [cited 2025 Jul 16]. p. 1-13. Available from: https://www.icumed.com/products/infusion-therapy/infusion-consumables/iv-connectors/clave-neutron/

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• Gilardi E, Grandi T, Giannuzzi R, Valletta F, Fugger S, Mazzaroppi S, et al. Long peripheral cannula in COVID-19 patients: 769 catheter days experience from a semi-intensive respiratory COVID unit. JVA [Internet]. 2024 Mar 5;25(2):498-503. Available from: https://journals.sagepub.com/doi/10.1177/11297298221115002

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• Fabiani A, Aversana N, Santoro M, Calandrino D, Liotta P, Sanson G. The longer the catheter, the lower the risk of complications: Results of the HERITAGE study comparing long peripheral and midline catheters. Am J Infect Control [Internet]. 2024 Nov;52(11):1289-95. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0196655324005807

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• Fabiani A, Santoro M, Sanson G. The catheter-to-vein ratio at the tip level, not the catheter type, as a risk factor for a catheter failure. A retrospective comparative study of polyurethane midline and long peripheral catheters. Hear Lung [Internet]. 2023 Jul;60:39-44. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0147956323000572

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  BACKGROUND

MeSH Terms

Conditions

Bites and Stings; Thrombosis

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Padilla-Nula F PhD candidate, Nurse

CONTACT

+ 34 973 24 81 00; FPADILLA@gencat.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Researchers will be responsible for catheter insertion and subsequent data collection; however, patients will be blinded to the type of needle-free connector used (with or without anti-reflux technology). In addition, the results will be evaluated by an independent researcher who is not involved in the data collection process.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Model Details: A classic parallel-group design will be used, consisting of an intervention group and a control group. The intervention group will receive catheters fitted with a needle-free connector featuring neutral fluid displacement and anti-reflux technology (Clave™ Neutron™, Ref. 011-NC139), whereas the control group will receive a needle-free connector with neutral fluid displacement but without anti-reflux technology (Microclave® Clear, Ref. 011-MC3302).

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 9, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: They will be available by the end of 2026.
• Access Criteria: DOI: 10.17632/jy54dx33pz.1