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Идёт набор NCT07212036

The Utilization of Ultrasound to Diagnose Pediatric Elbow Fractures

Без фазы С лечением Elbow Pain Supracondylar Humerus Fracture Radial Head Fractures Radial Head or Neck Fractures

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: Ultrasound of the elbow, X-ray of elbow.
Кому может быть актуально
Состояния в реестре: Elbow Pain, Supracondylar Humerus Fracture, Radial Head Fractures, Radial Head or Neck Fractures. Базовые параметры: до 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Utilization of Ultrasound to Diagnose Pediatric Elbow Fractures: Evaluation of Cost Savings, Radiation Exposure, and Patient Satisfaction

Обзор

The goal of this intervention trial is to learn if a ultrasound diagnosis of elbow fractures can improve care in pediatric patients seen in the emergency room. The main questions it aims to answer are: The primary outcomes measured are cost of the emergency visit, radiation exposure, time spent in the emergency department and patient satisfaction. Patients who are evaluated with ultrasounds of the elbow will be compared to patients who have x-rays of the elbow. Participants will be assigned either to the ultrasound group or x-rays group when they present with elbow pain.

Подробное описание

The goal of this study is to evaluate whether the use of point-of-care ultrasonography (PoCUS) for elbow trauma evaluation results in less radiation exposure, less cost of treatment and shorter length of stay in Emergency Room (ER) than use of radiography. The study team will use PoCUS to screen for isolated elbow fractures presented to the ER. The researchers will compare cost of treatment both for patients and health care system and length of stay in both the groups. This study will also evaluate whether the use of PoCUS alleviates discomfort to pediatric patients and increases satisfaction of the families as compared to the use of radiography. Family satisfaction surveys and patient pain surveys will act as direct measures of family satisfaction. The study team will use length of stay and cost of treatment as indirect measures of satisfaction. The researchers will compare amount of comfort and satisfaction with and without the use of PoCUS to evaluate the overall patient comfortability and patient satisfaction. The researchers hypothesize that the use of PoCUS will reduce time of emergency department length of stay, radiation exposure, pain or discomfort and cost, and will increase patient's and family satisfaction.

Вмешательства

  • Диагностический тест Ultrasound of the elbow
    An ultrasound of the elbow obtained of pediatric patients with elbow pain
  • Диагностический тест X-ray of elbow
    An x-ray of the elbow obtained of pediatric patients with elbow pain

Первичные конечные точки

  • Patient Satisfaction [Срок оценки: Day 1]
  • cost of treatment [Срок оценки: Day 1]
Вторичные конечные точки (2)
  • Length of Stay [Срок оценки: Day1]
  • Pain During Imaging Procedure [Срок оценки: Day 1]

Критерии участия

Критерии включения

  • Pediatric patient with elbow pain

Критерии исключения

  • Polytrauma (more than one injury)
  • Deformity of the arm including the elbow
  • Pain in any other location than the elbow
  • Pain in other parts of the same limb including the, wrist, forearm, shoulder, hand
  • Pain in other limbs,
  • Puckering of the skin (skin indentation)
  • Obvious fracture
  • Open wound at or around the elbow
  • Pain and swelling without trauma
  • Concerns for tumor or infection
  • Suspected nursemaid's elbow

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

США · 1 центр
  • Nemours Children's Hospital — Orlando

Публикации

  • Thukral BB. Problems and preferences in pediatric imaging. Indian J Radiol Imaging. 2015 Oct-Dec;25(4):359-64. doi: 10.4103/0971-3026.169466. PMID 26752721
  • Crowther M. Elbow pain in pediatrics. Curr Rev Musculoskelet Med. 2009 Jun;2(2):83-7. doi: 10.1007/s12178-009-9049-4. Epub 2009 Mar 14. PMID 19468873
  • Hall EJ. Lessons we have learned from our children: cancer risks from diagnostic radiology. Pediatr Radiol. 2002 Oct;32(10):700-6. doi: 10.1007/s00247-002-0774-8. Epub 2002 Jul 19. PMID 12244457
  • Avci M, Kozaci N, Beydilli I, Yilmaz F, Eden AO, Turhan S. The comparison of bedside point-of-care ultrasound and computed tomography in elbow injuries. Am J Emerg Med. 2016 Nov;34(11):2186-2190. doi: 10.1016/j.ajem.2016.08.054. Epub 2016 Aug 27. PMID 27645809
  • Lee SH, Yun SJ. Diagnostic Performance of Ultrasonography for Detection of Pediatric Elbow Fracture: A Meta-analysis. Ann Emerg Med. 2019 Oct;74(4):493-502. doi: 10.1016/j.annemergmed.2019.03.009. Epub 2019 May 9. PMID 31080032
  • Mettler FA Jr, Huda W, Yoshizumi TT, Mahesh M. Effective doses in radiology and diagnostic nuclear medicine: a catalog. Radiology. 2008 Jul;248(1):254-63. doi: 10.1148/radiol.2481071451. PMID 18566177
  • Burnier M, Buisson G, Ricard A, Cunin V, Pracros JP, Chotel F. Diagnostic value of ultrasonography in elbow trauma in children: Prospective study of 34 cases. Orthop Traumatol Surg Res. 2016 Nov;102(7):839-843. doi: 10.1016/j.otsr.2016.07.009. Epub 2016 Sep 30. PMID 27697406
  • Eckert K, Ackermann O, Janssen N, Schweiger B, Radeloff E, Liedgens P. Accuracy of the sonographic fat pad sign for primary screening of pediatric elbow fractures: a preliminary study. J Med Ultrason (2001). 2014 Oct;41(4):473-80. doi: 10.1007/s10396-014-0525-0. Epub 2014 Mar 6. PMID 27278028

Идентификаторы

NCT: NCT07212036 · 2051060

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗