Point-of-Care Ultrasonography for Intussusception
Primary Purpose
Intussusception, Emergencies
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Point-of-care ultrasound prior to radiology ultrasound
Radiology-performed ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Intussusception focused on measuring Point-of-care ultrasound, Intussusception, Pediatric Emergency Medicine, Ultrasound
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.
Sites / Locations
- Children's Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Point-of-care ultrasound prior to radiology ultrasound
Radiology-performed ultrasound
Arm Description
Outcomes
Primary Outcome Measures
Diagnostic accuracy of POCUS and RADUS for clinically important intussusception, expressed as sensitivity and specificity
Secondary Outcome Measures
Rates of recurrent intussusception
The number of patients with recurrent intussusception in each study arm
Rate of peritonitis
The number of patients with peritonitis in each study arm
Rate of bowel perforation
The number of patients with bowel perforation in each study arm
Rate of intestinal obstruction
The number of patients with intestinal obstruction in each study arm
Rate of shock
The number of patients with shock in each study arm
Rate of death
The number of deaths in each study arm
Emergency Department length of stay
Hospital length of stay (for patients admitted to the hospital)
Emergency Department laboratory investigations
The total number of laboratory investigations obtained per patient
Radiology studies
The total number of radiology studies obtained per patient
Emergency Department return visit at 3 days
Return ED visit 3 days after index ED visit
Emergency Department return visit at 7 days
Return ED visit 7 days after index ED visit
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
Full Information
NCT ID
NCT03360643
First Posted
November 20, 2017
Last Updated
August 31, 2023
Sponsor
Children's Hospitals and Clinics of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT03360643
Brief Title
Point-of-Care Ultrasonography for Intussusception
Official Title
Point-of-Care Ultrasonography for Intussusception: A Randomized Noninferiority Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
July 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospitals and Clinics of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intussusception, Emergencies
Keywords
Point-of-care ultrasound, Intussusception, Pediatric Emergency Medicine, Ultrasound
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
256 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Point-of-care ultrasound prior to radiology ultrasound
Arm Type
Active Comparator
Arm Title
Radiology-performed ultrasound
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Point-of-care ultrasound prior to radiology ultrasound
Intervention Description
Point-of-care ultrasound performed by pediatric emergency medicine physicians prior to radiology-performed ultrasound
Intervention Type
Diagnostic Test
Intervention Name(s)
Radiology-performed ultrasound
Intervention Description
Ultrasound performed an ultrasound technician and/or radiologist, and interpreted by a radiologist
Primary Outcome Measure Information:
Title
Diagnostic accuracy of POCUS and RADUS for clinically important intussusception, expressed as sensitivity and specificity
Time Frame
2 years from start of enrollment
Secondary Outcome Measure Information:
Title
Rates of recurrent intussusception
Description
The number of patients with recurrent intussusception in each study arm
Time Frame
2 years from start of enrollment
Title
Rate of peritonitis
Description
The number of patients with peritonitis in each study arm
Time Frame
2 years from start of enrollment
Title
Rate of bowel perforation
Description
The number of patients with bowel perforation in each study arm
Time Frame
2 years from start of enrollment
Title
Rate of intestinal obstruction
Description
The number of patients with intestinal obstruction in each study arm
Time Frame
2 years from start of enrollment
Title
Rate of shock
Description
The number of patients with shock in each study arm
Time Frame
2 years from start of enrollment
Title
Rate of death
Description
The number of deaths in each study arm
Time Frame
2 years from start of enrollment
Title
Emergency Department length of stay
Time Frame
2 years from start of enrollment
Title
Hospital length of stay (for patients admitted to the hospital)
Time Frame
2 years from start of enrollment
Title
Emergency Department laboratory investigations
Description
The total number of laboratory investigations obtained per patient
Time Frame
2 years from start of enrollment
Title
Radiology studies
Description
The total number of radiology studies obtained per patient
Time Frame
2 years after start of enrollment
Title
Emergency Department return visit at 3 days
Description
Return ED visit 3 days after index ED visit
Time Frame
3 days after the index ED visit
Title
Emergency Department return visit at 7 days
Description
Return ED visit 7 days after index ED visit
Time Frame
7 days after the index ED visit
Title
Differentiation of ileocolic and ileoileal intussusception, measured in centimeters
Description
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
Time Frame
2 years from start of enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Children's Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19018227
Citation
Waseem M, Rosenberg HK. Intussusception. Pediatr Emerg Care. 2008 Nov;24(11):793-800. doi: 10.1097/PEC.0b013e31818c2a3e.
Results Reference
background
PubMed Identifier
19657636
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.
Results Reference
background
PubMed Identifier
12557062
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.
Results Reference
background
PubMed Identifier
14634696
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.
Results Reference
background
PubMed Identifier
19303521
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.
Results Reference
background
PubMed Identifier
23517263
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.
Results Reference
background
PubMed Identifier
25548597
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.
Results Reference
background
PubMed Identifier
22424652
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.
Results Reference
background
PubMed Identifier
1640281
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.
Results Reference
background
PubMed Identifier
1509059
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.
Results Reference
background
PubMed Identifier
18208983
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.
Results Reference
background
PubMed Identifier
23610094
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.
Results Reference
background
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Point-of-Care Ultrasonography for Intussusception
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