Идёт набор NCT07509359

Comparing Basilic and Cephalic Vein Approaches for Midline Catheter Placement in Children

Без фазы С лечением Vascular Access Device Complications

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: Midline catheter placement via basilic vein, Midline catheter placement via cephalic vein.
Кому может быть актуально: Состояния в реестре: Vascular Access Device Complications. Базовые параметры: 2 лет — 17 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: South Korea
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Comparing Basilic and Cephalic Vein Approaches for Midline Catheter Placement in Children: A Randomized Controlled Trial

Обзор

This prospective randomized controlled trial aims to compare basilic vein and cephalic vein approaches for midline catheter placement in pediatric patients undergoing general anesthesia. Participants aged 2 to 17 years who require midline catheter insertion will be randomly assigned 1:1 to either the basilic vein group or the cephalic vein group. The primary outcome is the clinical blood sampling success rate during the catheter dwell period, defined as successful aspiration of ≥2 mL of blood through the midline catheter at least once without additional venipuncture. Secondary outcomes include operator-rated difficulty, number of puncture attempts, first attempt cannulation success rate, vein diameter and depth, catheter dwell time, catheter-related complications, and patient satisfaction. A total of 96 participants (48 per arm) will be enrolled at Seoul National University Children's Hospital.

Вмешательства

Процедура Midline catheter placement via basilic vein
Midline catheter placement via basilic vein under ultrasound guidance
Процедура Midline catheter placement via cephalic vein
Midline catheter placement via cephalic vein under ultrasound guidance

Первичные конечные точки

Clinical blood sampling success rate during catheter dwell period [Срок оценки: From catheter insertion until catheter removal (up to 7 days postoperatively)]

Вторичные конечные точки (8)

Operator-rated difficulty score [Срок оценки: At time of catheter insertion]
Number of puncture attempts [Срок оценки: At time of catheter insertion]
First attempt cannulation success rate [Срок оценки: At time of catheter insertion]
Standardized blood aspiration success [Срок оценки: Intraoperatively and postoperative day 1]
Allocated vein diameter and depth [Срок оценки: At time of catheter insertion]
Catheter dwell time [Срок оценки: From catheter insertion until catheter removal (up to 7 days postoperatively)]
Catheter-related complications [Срок оценки: From catheter insertion until catheter removal (up to 7 days postoperatively)]
Patient satisfaction score [Срок оценки: At catheter removal (up to 7 days postoperatively)]

Критерии участия

Критерии включения

Age 2-17 years undergoing general anesthesia
Midline catheter placement deemed necessary by attending anesthesiologist (≥1 of: expected ≥2 postop blood draws; expected blood loss ≥40% EBV; continuous antibiotic therapy; hospitalization ≥7 days; surgical team request)