Point-of-Care Ultrasonography for Intussusception

Emergencies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03360643
• Other study ID #: 1711-153
• Status: Completed
• Phase: N/A
• Start date: November 15, 2017
• Est. completion date: July 31, 2021

Study information

• Verified date: August 2023
• Source: Children's Hospitals and Clinics of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Intussusception

Intervention

Diagnostic Test:
• Point-of-care ultrasound prior to radiology ultrasound
Point-of-care ultrasound performed by pediatric emergency medicine physicians prior to radiology-performed ultrasound
• Radiology-performed ultrasound
Ultrasound performed an ultrasound technician and/or radiologist, and interpreted by a radiologist

Locations

Country	Name	City	State
United States	Children's Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospitals and Clinics of Minnesota

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

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

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of POCUS and RADUS for clinically important intussusception, expressed as sensitivity and specificity		2 years from start of enrollment
Secondary	Rates of recurrent intussusception	The number of patients with recurrent intussusception in each study arm	2 years from start of enrollment
Secondary	Rate of peritonitis	The number of patients with peritonitis in each study arm	2 years from start of enrollment
Secondary	Rate of bowel perforation	The number of patients with bowel perforation in each study arm	2 years from start of enrollment
Secondary	Rate of intestinal obstruction	The number of patients with intestinal obstruction in each study arm	2 years from start of enrollment
Secondary	Rate of shock	The number of patients with shock in each study arm	2 years from start of enrollment
Secondary	Rate of death	The number of deaths in each study arm	2 years from start of enrollment
Secondary	Emergency Department length of stay		2 years from start of enrollment
Secondary	Hospital length of stay (for patients admitted to the hospital)		2 years from start of enrollment
Secondary	Emergency Department laboratory investigations	The total number of laboratory investigations obtained per patient	2 years from start of enrollment
Secondary	Radiology studies	The total number of radiology studies obtained per patient	2 years after start of enrollment
Secondary	Emergency Department return visit at 3 days	Return ED visit 3 days after index ED visit	3 days after the index ED visit
Secondary	Emergency Department return visit at 7 days	Return ED visit 7 days after index ED visit	7 days after the index ED visit
Secondary	Differentiation of ileocolic and ileoileal intussusception, measured in centimeters	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	2 years from start of enrollment