Point-of-Care Ultrasonography for Intussusception



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:Any - 6
Updated:2/1/2019
Start Date:November 15, 2017
End Date:December 31, 2020

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

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.

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.
We found this trial at
1
site
Minneapolis, Minnesota 55404
Phone: 612-813-6843
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Minneapolis, MN
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