Point-of-Care Ultrasonography for Intussusception

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intussusception, Emergencies

Intervention / Treatment
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* Diagnostic Test: Point-of-care ultrasound prior to radiology ultrasound
* Diagnostic Test: Radiology-performed ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children 3 months through 6 years of age; Clinical suspicion for intussusception per treating emergency physician. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Point-of-care ultrasound prior to radiology ultrasound<br> | Diagnostic Test: Point-of-care ultrasound prior to radiology ultrasound<br>* Point-of-care ultrasound performed by pediatric emergency medicine physicians prior to radiology-performed ultrasound<br>|
| Active Comparator: Radiology-performed ultrasound<br> | Diagnostic Test: Radiology-performed ultrasound<br>* Ultrasound performed an ultrasound technician and/or radiologist, and interpreted by a radiologist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of POCUS and RADUS for clinically important intussusception, expressed as sensitivity and specificity |  | 2 years from start of enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of recurrent intussusception | The number of patients with recurrent intussusception in each study arm | 2 years from start of enrollment | 
| Rate of peritonitis | The number of patients with peritonitis in each study arm | 2 years from start of enrollment | 
| Rate of bowel perforation | The number of patients with bowel perforation in each study arm | 2 years from start of enrollment | 
| Rate of intestinal obstruction | The number of patients with intestinal obstruction in each study arm | 2 years from start of enrollment | 
| Rate of shock | The number of patients with shock in each study arm | 2 years from start of enrollment | 
| Rate of death | The number of deaths in each study arm | 2 years from start of enrollment | 
| Emergency Department length of stay |  | 2 years from start of enrollment | 
| Hospital length of stay (for patients admitted to the hospital) |  | 2 years from start of enrollment | 
| Emergency Department laboratory investigations | The total number of laboratory investigations obtained per patient | 2 years from start of enrollment | 
| Radiology studies | The total number of radiology studies obtained per patient | 2 years after start of enrollment | 
| Emergency Department return visit at 3 days | Return ED visit 3 days after index ED visit | 3 days after the index ED visit | 
| Emergency Department return visit at 7 days | Return ED visit 7 days after index ED visit | 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 | 2 years from start of enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Point-of-care ultrasound, Intussusception, Pediatric Emergency Medicine, Ultrasound