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临床试验/NCT05971745
NCT05971745已完成不适用

Accuracy of Pediatric Emergency Medicine Providers in Diagnosing Hip Effusions Using Point of Care Ultrasound

Connecticut Children's Medical Center6 个研究点 分布在 2 个国家目标入组 161 人开始时间: 2019年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
161
试验地点
6
主要终点
The presence of absence of a hip effusion.

研究概览

简要总结

The purpose of this study is to determine if pediatric emergency medicine providers can accurately diagnose a hip effusion using point-of-care ultrasound (POCUS) compared to radiology ultrasound (RADUS).

详细描述

The purpose of this study is to determine that the accuracy of trained pediatric emergency medicine providers to diagnose hip effusion using point-of-care ultrasound (POCUS) is non-inferior to the reference standard of radiology ultrasound (RADUS). Additionally, the investigators seek to compare how POCUS performs against other clinical tests or investigations for the diagnosis of septic arthritis. The investigators hypothesize that trained EM providers will be able to diagnose hip effusions with high (>90%) accuracy compared to studies conducted by the Department of Radiology.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years or younger
  • Clinical presentation necessitating hip ultrasonography as determined by the evaluating clinician
  • Study physician available at the time of presentation to ED
  • Patient or legal guardian provides consent

排除标准

  • Children who present when a study physician is not available or those for whom consent is not given.
  • Children who have had hip ultrasound imaging prior to their ED visit. Children with prior hip/pelvis x-rays will not be excluded.

结局指标

主要结局

The presence of absence of a hip effusion.

时间窗: From the time the radiologist reviews the ultrasound as performed by the radiology technician during the emergency department visit, through study completion, average of 2 years.

The presence or absence of an effusion as determined by the Radiologist on both the affected and unaffected sides.

The presence or absence of a hip effusion.

时间窗: From the time the point-of-care ultrasound is performed by the physician during the emergency department visit through study completion, average of 2 years.

The presence or absence of an effusion as determined by the pediatric emergency medicine physician performing the point-of-care-ultrasound study on both the affected and unaffected sides (i.e. right hip and left hip).

次要结局

  • The size of the effusion.(From the time the point-of-care ultrasound is performed by the physician during the emergency department visit to study completion, average of 2 years)
  • The location of the measurement of the effusion.(Upon chart review: between the time the measurement was obtained in the emergency department up to six weeks later when the chart is reviewed by primary investigator.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ruchika Jones

Principal Investigator

Connecticut Children's Medical Center

研究点 (6)

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