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Идёт набор NCT07429344

EASY Algorithm Trial (Elbow Trauma Assessment Using Sonography in Children and Youth) Diagnostic Accuracy and Safety of Point-of-care Ultrasound as a Screening Tool for Suspected Elbow Fractures in Children Aged 5 to 15 Years: a Multicenter Prospective Cohort Study

— Наблюдательное Elbow Fractures Distal Humerus Fracture Pediatric Trauma Radius Fracture

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Elbow Fractures, Distal Humerus Fracture, Pediatric Trauma, Radius Fracture. Базовые параметры: 5 лет — 15 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
Германия
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

EASY Algorithm Trial (Elbow Trauma Assessment Using Sonography in Children and Youth) Diagnostic Accuracy and Safety of Point-of-care Ultrasound as a Screening Tool for Suspected Elbow Fractures in Children Aged 5 to 15 Years: a Multicenter Prospective Cohort Study by the German Section for Pediatric Traumatology (SKT)

Обзор

The goal of this observational study is to learn about the safety and accuracy of ultrasound as a screening tool to detect broken bones (fractures) in the elbow area in children and youth aged 5 to 15 years. The main question it aims to answer is: \- Can ultrasound reliably show that there is a fracture in the elbow area after an accident? Participants will: * Have an ultrasound of their elbow to look for fluid in the joint. * Have standard X-rays of their elbow to check if there is a fracture. * Have their medical records checked and answer a phone call 6 weeks later to see how their elbow has healed (only if no fracture was found during the first visit).

Первичные конечные точки

  • Sensitivity of sonographic joint effusion [Срок оценки: Day 1 (On the day of enrollment in the study in the emergency department)]
Вторичные конечные точки (11)
  • Time required for ultrasound examination [Срок оценки: Day 1 (On the day of enrollment in the study in the emergency department)]
  • The additional time patients spend in the emergency room due to X-ray examinations [Срок оценки: Day 1 (On the day of enrollment in the study in the emergency department)]
  • Radiation dose from X-ray imaging (dose area product) [Срок оценки: Day 1 (On the day of enrollment in the study in the emergency department)]
  • The initial assessment of the X-ray images by the attending physician in the emergency department [Срок оценки: Day 1 (On the day of enrollment in the study in the emergency department)]
  • Treatment of the injury [Срок оценки: Day 1 (On the day of enrollment in the study in the emergency department)]
  • Exact fracture pattern of the initial X-ray images as determined by blinded experts [Срок оценки: Day 1 (On the day of enrollment in the study in the emergency department)]
  • Radiographic posterior fat pad signs on the initial X-ray images as determined by blinded experts [Срок оценки: Day 1 (On the day of enrollment in the study in the emergency department)]
  • Interrater reliability of ultrasound findings [Срок оценки: Day 1 (On the day of enrollment in the study in the emergency department)]
  • Only in cases where there is initially no radiographically confirmed fracture: pain after 6 weeks [Срок оценки: Day 39-45 (42 days (+/- 3 days) after the day of enrollment in the study in the emergency department)]
  • Only in cases where there is initially no radiographically confirmed fracture: function of the upper extremity after 6 weeks [Срок оценки: Day 39-45 (42 days (+/- 3 days) after the day of enrollment in the study in the emergency department)]
  • Only in cases where there is initially no radiographically confirmed fracture: Medical follow-up appointments and results of possible further radiological imaging [Срок оценки: Day 39-45 (42 days (+/- 3 days) after the day of enrollment in the study in the emergency department)]

Критерии участия

Критерии включения

  • children and adolescents aged 5-15 years with anamnestic and clinically justified need for the exclusion of a fracture after elbow trauma

Критерии исключения

  • elbow trauma as part of a polytrauma,
  • parents' insufficient German language skills (spoken or written),
  • trauma more than 72 hours ago,
  • presentation at the emergency room with current, post-traumatic external X-ray images of the affected elbow joint from another clinic or practice,
  • open fracture of the affected elbow joint,
  • skin avulsion of the affected elbow joint,
  • visible deformity of the affected elbow joint,
  • and pathological status of peripheral circulation, motor function, and/or sensitivity.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Германия · 13 центров
  • Klinikum St. Marien Amberg — Amberg
  • Vivantes Klinikum Neukölln — Berlin
  • Helios Klinikum Berlin-Buch — Berlin
  • Charité - Universitätsmedizin Berlin — Berlin
  • Klinikum Chemnitz — Chemnitz
  • Universitätsklinikum Carl Gustav Carus Dresden — Dresden
  • BG Klinikum Duisburg — Duisburg
  • Universitätsklinikum Freiburg — Freiburg im Breisgau
  • … и ещё 5 центров

Идентификаторы

NCT: NCT07429344 · EA2/215/25

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗