Point-of-Care Ultrasonography for Intussusception

NCT ID: NCT03360643

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-15
• Study Completion Date: 2021-07-31

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.

Conditions

Intussusception; Emergencies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Point-of-care ultrasound prior to radiology ultrasound

Group Type: ACTIVE_COMPARATOR

Point-of-care ultrasound prior to radiology ultrasound

Intervention Type: DIAGNOSTIC_TEST

Point-of-care ultrasound performed by pediatric emergency medicine physicians prior to radiology-performed ultrasound

Radiology-performed ultrasound

Group Type: ACTIVE_COMPARATOR

Radiology-performed ultrasound

Intervention Type: DIAGNOSTIC_TEST

Ultrasound performed an ultrasound technician and/or radiologist, and interpreted by a radiologist

Interventions

Point-of-care ultrasound prior to radiology ultrasound

Point-of-care ultrasound performed by pediatric emergency medicine physicians prior to radiology-performed ultrasound

Intervention Type: DIAGNOSTIC_TEST

Radiology-performed ultrasound

Ultrasound performed an ultrasound technician and/or radiologist, and interpreted by a radiologist

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospitals and Clinics of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Kelly Bergmann, DO, MS

Emergency Research Director, Pediatric Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's Minnesota

Minneapolis, Minnesota, United States

Countries

United States

References

Waseem M, Rosenberg HK. Intussusception. Pediatr Emerg Care. 2008 Nov;24(11):793-800. doi: 10.1097/PEC.0b013e31818c2a3e.

Reference Type: BACKGROUND

PMID: 19018227 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19657636 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12557062 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14634696 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19303521 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23517263 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25548597 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22424652 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1640281 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1509059 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18208983 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23610094 (View on PubMed)

Other Identifiers

1711-153

Identifier Type: -

Identifier Source: org_study_id