Clinical trial NCT03360643: Point-of-Care Ultrasonography for Intussusception
Official title: Point-of-Care Ultrasonography for Intussusception: A Randomized Noninferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intussusception
Emergencies
Keywords: Point-of-care ultrasound
Intussusception
Pediatric Emergency Medicine
Ultrasound
Lead sponsor: Children's Hospitals and Clinics of Minnesota
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 256
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic accuracy of POCUS and RADUS for clinically important intussusception, expressed as sensitivity and specificity
timeFrame: 2 years from start of enrollment
Secondary outcomes:
measure: Rates of recurrent intussusception
timeFrame: 2 years from start of enrollment
measure: Rate of peritonitis
timeFrame: 2 years from start of enrollment
measure: Rate of bowel perforation
timeFrame: 2 years from start of enrollment
measure: Rate of intestinal obstruction
timeFrame: 2 years from start of enrollment
measure: Rate of shock
timeFrame: 2 years from start of enrollment
measure: Rate of death
timeFrame: 2 years from start of enrollment
measure: Emergency Department length of stay
timeFrame: 2 years from start of enrollment
measure: Hospital length of stay (for patients admitted to the hospital)
timeFrame: 2 years from start of enrollment
measure: Emergency Department laboratory investigations
timeFrame: 2 years from start of enrollment
measure: Radiology studies
timeFrame: 2 years after start of enrollment
measure: Emergency Department return visit at 3 days
timeFrame: 3 days after the index ED visit
measure: Emergency Department return visit at 7 days
timeFrame: 7 days after the index ED visit
measure: Differentiation of ileocolic and ileoileal intussusception, measured in centimeters
timeFrame: 2 years from start of enrollment
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Children's Minnesota
state: Minnesota
Study officials:
References:
citation: Waseem M, Rosenberg HK. Intussusception. Pediatr Emerg Care. 2008 Nov;24(11):793-800. doi: 10.1097/PEC.0b013e31818c2a3e.
citation: Hryhorczuk AL, Strouse PJ. Validation of US as a first-line diagnostic test for assessment of pediatric ileocolic intussusception. Pediatr Radiol. 2009 Oct;39(10):1075-9. doi: 10.1007/s00247-009-1353-z. Epub 2009 Aug 6.
citation: Daneman A, Navarro O. Intussusception. Part 1: a review of diagnostic approaches. Pediatr Radiol. 2003 Feb;33(2):79-85. doi: 10.1007/s00247-002-0832-2. Epub 2002 Nov 19.
citation: Daneman A, Navarro O. Intussusception. Part 2: An update on the evolution of management. Pediatr Radiol. 2004 Feb;34(2):97-108; quiz 187. doi: 10.1007/s00247-003-1082-7. Epub 2003 Nov 21.
citation: American College of Emergency Physicians. Emergency ultrasound guidelines. Ann Emerg Med. 2009 Apr;53(4):550-70. doi: 10.1016/j.annemergmed.2008.12.013. No abstract available.
citation: Vieira RL, Hsu D, Nagler J, Chen L, Gallagher R, Levy JA; American Academy of Pediatrics. Pediatric emergency medicine fellow training in ultrasound: consensus educational guidelines. Acad Emerg Med. 2013 Mar;20(3):300-6. doi: 10.1111/acem.12087.
citation: Lam SH, Wise A, Yenter C. Emergency bedside ultrasound for the diagnosis of pediatric intussusception: a retrospective review. World J Emerg Med. 2014;5(4):255-8. doi: 10.5847/wjem.j.issn.1920-8642.2014.04.002.
citation: Riera A, Hsiao AL, Langhan ML, Goodman TR, Chen L. Diagnosis of intussusception by physician novice sonographers in the emergency department. Ann Emerg Med. 2012 Sep;60(3):264-8. doi: 10.1016/j.annemergmed.2012.02.007. Epub 2012 Mar 15.
citation: Bhisitkul DM, Listernick R, Shkolnik A, Donaldson JS, Henricks BD, Feinstein KA, Fernbach SK. Clinical application of ultrasonography in the diagnosis of intussusception. J Pediatr. 1992 Aug;121(2):182-6. doi: 10.1016/s0022-3476(05)81185-0.
citation: Verschelden P, Filiatrault D, Garel L, Grignon A, Perreault G, Boisvert J, Dubois J. Intussusception in children: reliability of US in diagnosis--a prospective study. Radiology. 1992 Sep;184(3):741-4. doi: 10.1148/radiology.184.3.1509059.
citation: Williams H. Imaging and intussusception. Arch Dis Child Educ Pract Ed. 2008 Feb;93(1):30-6. doi: 10.1136/adc.2007.134304. No abstract available.
citation: Ahn S, Park SH, Lee KH. How to demonstrate similarity by using noninferiority and equivalence statistical testing in radiology research. Radiology. 2013 May;267(2):328-38. doi: 10.1148/radiol.12120725.