Меню
Идёт набор NCT07450729

GLUEPED2024: Study on the Use of Peripheral Venous Catheters in Pediatric Patients With Emergency Room Access.

Без фазы С лечением Venous Catheterization

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: cyanoacrylate glue.
Кому может быть актуально
Состояния в реестре: Venous Catheterization. Базовые параметры: 0 лет — 18 лет · 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
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Randomized, Open-label, Parallel-arm, Controlled Study to Evaluate the Stabilization of Peripheral Venous Catheters Through the Application of Cyanoacrylate Skin Adhesive to the Exit Site in Pediatric Patients With Emergency Room Access.

Обзор

A venous access device (VADs) is a biocompatible plastic catheter that establishes a connection between the skin surface and a venous system. They can be categorized using various classifications; notably, based on the position of the catheter tip, they are distinguished into central venous catheters (CVCs) and peripheral venous catheters (PVCs). Depending on their length, PVCs can be further divided into long-cannula PVCs and short-cannula PVCs. Currently, these catheters are stabilized "in situ" using transparent semipermeable dressings with a high moisture vapor transmission rate (MVTR), which keep the insertion site visible. Considering the pediatric patient population, this type of stabilization is currently somewhat archaic, and accidental displacement of PVCs is frequently encountered, along with subsequent complications such as extravasation, occlusion, phlebitis, and local infections. The addition of skin glue to the transparent semipermeable dressing ensures optimal stabilization of the device, reducing dislodgement, further complications, and consequently the need for multiple punctures for repositioning. Due to various clinical conditions, some patients presenting to the Emergency Department have a venous network that is difficult to identify by direct visualization or palpation. In these patients, the occurrence of an accidental displacement would significantly compromise the quality of care. Currently, there are no studies in the literature conducted in a pediatric emergency department that demonstrate the superiority of using cyanoacrylate glue for PVC stabilization compared to the semipermeable dressing alone. This study aim to investigate the use of cyanoacrylate glue for stabilizing venous access devices in the emergency setting as well, and to evaluate potential improvements to current daily clinical practice. The primary objective is to evaluate whether applying cyanoacrylate skin glue at the exit site provides better stabilization of a correctly placed peripheral venous catheter (PVC) compared to PVC stabilization with a transparent semipermeable dressing alone.

Вмешательства

  • Процедура cyanoacrylate glue
    Tissue adhesive to properly seal the venipuncture site and fix the catheter optimally to limit the risk of complications.

Первичные конечные точки

  • Number of dislocations of the vascular access device (VADs) [Срок оценки: 6 hours post- VADs insertion]
Вторичные конечные точки (3)
  • Number of dislocations of the vascular access device (VADs) [Срок оценки: 12, 24, 36, 48, and 72 hours post- VADs insertion]
  • Change in Visual Exit Site (VES) score [Срок оценки: 6, 12, 24, 36, 48, and 72 hours post- VADs insertion]
  • Correlation between the percentage of displacement of venous access device and DIVA score. [Срок оценки: 6, 12, 24, 36, 48, and 72 hours post- VADs insertion]

Критерии участия

Критерии включения

  • Age 0-18 years old
  • Venous access device for at least 24 hours.
  • Informed consent form signed

Критерии исключения

  • Patients with language barriers
  • patients with pre-existing central venous access
  • patients requiring immediate surgery with venous access placed under sedation
  • skin lesions in the affected area
  • patients exhibiting psychomotor agitation
  • patients assigned to the emergency code
  • unaccompanied minors

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
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Италия · 1 центр
  • Meyer Children's Hospital IRCCS, Firenze — Florence

Идентификаторы

NCT: NCT07450729 · GLUEPED2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗