Point-of-Care Ultrasonography for Intussusception

Not Applicable

Completed

• Conditions: Intussusception; Emergencies
• Interventions: Diagnostic Test: Radiology-performed ultrasound; Diagnostic Test: Point-of-care ultrasound prior to radiology ultrasound

• Registration Number: NCT03360643
• Lead Sponsor: Children's Hospitals and Clinics of Minnesota

Brief 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.

Study Timeline

• Study Start: 2017-11-15
• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2017-12-01
• Study First Posted: 2017-12-04
• Primary Completion: 2020-07-31
• Study Completion: 2021-07-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiology-performed ultrasound	Radiology-performed ultrasound	-
Point-of-care ultrasound prior to radiology ultrasound	Point-of-care ultrasound prior to radiology ultrasound	-

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of POCUS and RADUS for clinically important intussusception, expressed as sensitivity and specificity	2 years from start of enrollment

Secondary Outcome Measures

Name	Time	Method
Emergency Department return visit at 3 days	3 days after the index ED visit	Return ED visit 3 days after index ED visit
Emergency Department return visit at 7 days	7 days after the index ED visit	Return ED visit 7 days after index ED visit
Rates of recurrent intussusception	2 years from start of enrollment	The number of patients with recurrent intussusception in each study arm
Rate of bowel perforation	2 years from start of enrollment	The number of patients with bowel perforation in each study arm
Emergency Department length of stay	2 years from start of enrollment
Rate of death	2 years from start of enrollment	The number of deaths in each study arm
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	The number of patients with peritonitis in each study arm
Rate of intestinal obstruction	2 years from start of enrollment	The number of patients with intestinal obstruction in each study arm
Rate of shock	2 years from start of enrollment	The number of patients with shock in each study arm
Radiology studies	2 years after start of enrollment	The total number of radiology studies obtained per patient
Emergency Department laboratory investigations	2 years from start of enrollment	The total number of laboratory investigations obtained per patient
Differentiation of ileocolic and ileoileal intussusception, measured in centimeters	2 years from start of enrollment	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

Trial Locations

Locations (1)

Children's Minnesota; 🇺🇸 Minneapolis, Minnesota, United States