An interventional study of Point-of-care ultrasound prior to radiology ultrasound and Radiology-performed ultrasound in Intussusception and Emergencies, sponsored by Children's Hospitals and Clinics of Minnesota. Completed at 1 site in United States. Open to participants aged 3 Months to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-01.
Sponsored by Children's Hospitals and Clinics of Minnesota · Not applicable, Interventional, and Diagnostic
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.
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.
Exclusion Criteria:
Diagnostic Test: Point-of-care ultrasound prior to radiology ultrasound
Diagnostic Test: Radiology-performed ultrasound
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
Diagnostic accuracy of POCUS and RADUS for clinically important intussusception, expressed as sensitivity and specificity
Time frame: 2 years from start of enrollment
Rates of recurrent intussusception
The number of patients with recurrent intussusception in each study arm
Time frame: 2 years from start of enrollment
Rate of peritonitis
The number of patients with peritonitis in each study arm
Time frame: 2 years from start of enrollment
Rate of bowel perforation
The number of patients with bowel perforation in each study arm
Time frame: 2 years from start of enrollment
Rate of intestinal obstruction
The number of patients with intestinal obstruction in each study arm
Time frame: 2 years from start of enrollment
Rate of shock
The number of patients with shock in each study arm
Time frame: 2 years from start of enrollment
Rate of death
The number of deaths in each study arm
Time frame: 2 years from start of enrollment
Emergency Department length of stay
Time frame: 2 years from start of enrollment
Hospital length of stay (for patients admitted to the hospital)
Time frame: 2 years from start of enrollment
Emergency Department laboratory investigations
The total number of laboratory investigations obtained per patient
Time frame: 2 years from start of enrollment
Radiology studies
The total number of radiology studies obtained per patient
Time frame: 2 years after start of enrollment
Emergency Department return visit at 3 days
Return ED visit 3 days after index ED visit
Time frame: 3 days after the index ED visit
Emergency Department return visit at 7 days
Return ED visit 7 days after index ED visit
Time frame: 7 days after the index ED visit
Differentiation of ileocolic and ileoileal intussusception, measured in centimeters
Ileocolic intussusception will be identified by a maximal cross-sectional diameter of greater than or equal to 2.5 cm; and ileoileal intussusception will be considered less than 2.5 cm in maximal cross-sectional diameter
Time frame: 2 years from start of enrollment
Plan to share: No
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Children's Hospitals and Clinics of Minnesota