Point-of-Care Ultrasonography for Intussusception
Condition: Intussusception; Emergencies
MeSH terms: Intussusception; Emergencies
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Point-of-care ultrasound prior to radiology ultrasound; Radiology-performed ultrasound
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Point-of-care ultrasound performed by pediatric emergency medicine physicians prior to radiology-performed ultrasound; Ultrasound performed an ultrasound technician and/or radiologist, and interpreted by a radiologist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Point-of-care ultrasound; Intussusception; Pediatric Emergency Medicine; Ultrasound