NCT03360643

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 4, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

2.7 years

First QC Date

November 20, 2017

Last Update Submit

August 31, 2023

Conditions

IntussusceptionEmergencies

Keywords

Point-of-care ultrasoundIntussusceptionPediatric Emergency MedicineUltrasound

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of POCUS and RADUS for clinically important intussusception, expressed as sensitivity and specificity

    2 years from start of enrollment

Secondary Outcomes (13)

  • Rates of recurrent intussusception

    2 years from start of enrollment

  • Rate of peritonitis

    2 years from start of enrollment

  • Rate of bowel perforation

    2 years from start of enrollment

  • Rate of intestinal obstruction

    2 years from start of enrollment

  • Rate of shock

    2 years from start of enrollment

  • +8 more secondary outcomes

Study Arms (2)

Point-of-care ultrasound prior to radiology ultrasound

ACTIVE COMPARATOR
Diagnostic Test: Point-of-care ultrasound prior to radiology ultrasound

Radiology-performed ultrasound

ACTIVE COMPARATOR
Diagnostic Test: Radiology-performed ultrasound

Interventions

Point-of-care ultrasound prior to radiology ultrasoundDIAGNOSTIC_TEST

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

Point-of-care ultrasound prior to radiology ultrasound
Radiology-performed ultrasoundDIAGNOSTIC_TEST

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

Radiology-performed ultrasound

Eligibility Criteria

Age3 Months - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Minnesota

Minneapolis, Minnesota, 55404, United States

Location

Related Publications (12)

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

    PMID: 19018227BACKGROUND

  • 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.

    PMID: 19657636BACKGROUND

  • 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.

    PMID: 12557062BACKGROUND

  • 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.

    PMID: 14634696BACKGROUND

  • 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.

    PMID: 19303521BACKGROUND

  • 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.

    PMID: 23517263BACKGROUND

  • 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.

    PMID: 25548597BACKGROUND

  • 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.

    PMID: 22424652BACKGROUND

  • 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.

    PMID: 1640281BACKGROUND

  • 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.

    PMID: 1509059BACKGROUND

  • 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.

    PMID: 18208983BACKGROUND

  • 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.

    PMID: 23610094BACKGROUND

MeSH Terms

Conditions

IntussusceptionEmergencies

Condition Hierarchy (Ancestors)

Intestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emergency Research Director, Pediatric Emergency Medicine

Study Record Dates

First Submitted

November 20, 2017

First Posted

December 4, 2017

Study Start

November 15, 2017

Primary Completion

July 31, 2020

Study Completion

July 31, 2021

Last Updated

September 1, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)