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临床试验/NCT03360643
NCT03360643已完成不适用

Point-of-Care Ultrasonography for Intussusception: A Randomized Noninferiority Trial

Children's Hospitals and Clinics of Minnesota2 个研究点 分布在 1 个国家目标入组 256 人开始时间: 2017年11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
256
试验地点
2
主要终点
Diagnostic accuracy of POCUS and RADUS for clinically important intussusception, expressed as sensitivity and specificity

研究概览

简要总结

Pediatric emergency medicine (PEM) physicians are increasingly utilizing point-of-care ultrasound (POCUS). There is currently limited data regarding POCUS evaluation for intussusception in pediatric patients. To better understand the role of POCUS for identification of intussusception, the investigators plan to conduct a randomized, noninferiority study comparing POCUS and radiology-performed ultrasound (RADUS), utilizing experienced sonographers across multiple institutions.

详细描述

Intussusception is the most common causes of bowel obstruction among children less than 6 years of age. Limited abdominal ultrasonography is recommended as the initial screening study, prior to enema or surgical reduction for definitive treatment. Although ultrasonography is typically performed by ultrasound technicians and interpreted by radiologists, recently published guidelines include identification of intussusception as an adjunct POCUS application for emergency physicians to use at the bedside.

Two previous studies have investigated POCUS use by PEM physicians for the diagnosis of intussusception, both of which largely incorporated novice sonographers with limited training in bowel ultrasonography. Only one previous prospective investigation has investigated POCUS for the identification of intussusception, with a reported POCUS sensitivity of 85% (95% confidence interval 54-97%) and specificity of 97% (95% confidence interval 89-99%) when compared to RADUS. In contrast, the sensitivity and specificity of RADUS have been reported to range from 98-100% and 88-98%, respectively, when compared to enema or surgical reduction. Given the limited evidence available, it remains unclear whether POCUS performs similar to RADUS in terms of diagnostic accuracy.

The primary aim of this study is to determine whether POCUS is noninferior to RADUS for the detection of intussusception. The secondary aims are to determine whether rates of serious complications or resource utilization measures differ among patients randomly assigned to receive POCUS prior to RADUS or RADUS alone. The investigators hypothesize that diagnostic accuracy, expressed as sensitivity and specificity, is similar for POCUS and RADUS, and that rates of serious complications and resource utilization measures do not differ across groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
3 Months 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children 3 months through 6 years of age;
  • Clinical suspicion for intussusception per treating emergency physician.

排除标准

  • Need for critical care resuscitation (intubation or vasopressors);
  • Emergent situation where the treating provider determines that POCUS prior to RADUS may interfere with clinical care.

结局指标

主要结局

Diagnostic accuracy of POCUS and RADUS for clinically important intussusception, expressed as sensitivity and specificity

时间窗: 2 years from start of enrollment

次要结局

  • Rates of recurrent intussusception(2 years from start of enrollment)
  • Rate of bowel perforation(2 years from start of enrollment)
  • Emergency Department length of stay(2 years from start of enrollment)
  • Rate of death(2 years from start of enrollment)
  • Hospital length of stay (for patients admitted to the hospital)(2 years from start of enrollment)
  • Rate of peritonitis(2 years from start of enrollment)
  • Rate of intestinal obstruction(2 years from start of enrollment)
  • Rate of shock(2 years from start of enrollment)
  • Radiology studies(2 years after start of enrollment)
  • Emergency Department return visit at 3 days(3 days after the index ED visit)
  • Emergency Department return visit at 7 days(7 days after the index ED visit)
  • Emergency Department laboratory investigations(2 years from start of enrollment)
  • Differentiation of ileocolic and ileoileal intussusception, measured in centimeters(2 years from start of enrollment)

研究者

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

Kelly Bergmann, DO, MS

Emergency Research Director, Pediatric Emergency Medicine

Children's Hospitals and Clinics of Minnesota

研究点 (2)

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