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Набор скоро начнётся 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

Без фазы С лечением Vascular Access Devices Catheters Occlusion Thrombosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 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.
Кому может быть актуально
Состояния в реестре: Vascular Access Devices, Catheters, Occlusion, Thrombosis. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

  • Процедура 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.
  • Процедура 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.
  • Устройство Long peripheral venous catheter
    Placement of a 20-gauge long PVC in an arm vein using the AST.
  • Другое Ultrasound scanner
    All punctures will be performed under ultrasound guidance.

Первичные конечные точки

  • Number of participants who experienced device-related adverse events, classified according to CTCAE v5.0. [Срок оценки: 7 days]
Вторичные конечные точки (1)
  • Number of participants with partial or complete occlusions in long peripheral venous catheters, as assessed using the CINAS scale (UZ Leuven®). [Срок оценки: 7 days]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • 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/

Идентификаторы

NCT: NCT07519304 · 04/25

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗