Point-of-Care Ultrasonography for Intussusception

Sponsor
Children's Hospitals and Clinics of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT03360643
Collaborator
(none)
256
1
2
44.5
5.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Point-of-care ultrasound prior to radiology ultrasound
  • Diagnostic Test: Radiology-performed ultrasound
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
256 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Point-of-Care Ultrasonography for Intussusception: A Randomized Noninferiority Trial
Actual Study Start Date :
Nov 15, 2017
Actual Primary Completion Date :
Jul 31, 2020
Actual Study Completion Date :
Jul 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Point-of-care ultrasound prior to radiology ultrasound

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

Active Comparator: Radiology-performed ultrasound

Diagnostic Test: Radiology-performed ultrasound
Ultrasound performed an ultrasound technician and/or radiologist, and interpreted by a radiologist

Outcome Measures

Primary Outcome Measures

  1. Diagnostic accuracy of POCUS and RADUS for clinically important intussusception, expressed as sensitivity and specificity [2 years from start of enrollment]

Secondary Outcome Measures

  1. Rates of recurrent intussusception [2 years from start of enrollment]

    The number of patients with recurrent intussusception in each study arm

  2. Rate of peritonitis [2 years from start of enrollment]

    The number of patients with peritonitis in each study arm

  3. Rate of bowel perforation [2 years from start of enrollment]

    The number of patients with bowel perforation in each study arm

  4. Rate of intestinal obstruction [2 years from start of enrollment]

    The number of patients with intestinal obstruction in each study arm

  5. Rate of shock [2 years from start of enrollment]

    The number of patients with shock in each study arm

  6. Rate of death [2 years from start of enrollment]

    The number of deaths in each study arm

  7. Emergency Department length of stay [2 years from start of enrollment]

  8. Hospital length of stay (for patients admitted to the hospital) [2 years from start of enrollment]

  9. Emergency Department laboratory investigations [2 years from start of enrollment]

    The total number of laboratory investigations obtained per patient

  10. Radiology studies [2 years after start of enrollment]

    The total number of radiology studies obtained per patient

  11. Emergency Department return visit at 3 days [3 days after the index ED visit]

    Return ED visit 3 days after index ED visit

  12. Emergency Department return visit at 7 days [7 days after the index ED visit]

    Return ED visit 7 days after index ED visit

  13. Differentiation of ileocolic and ileoileal intussusception, measured in centimeters [2 years from start of enrollment]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Months to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Minnesota Minneapolis Minnesota United States 55404

Sponsors and Collaborators

  • Children's Hospitals and Clinics of Minnesota

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Kelly Bergmann, DO, MS, Emergency Research Director, Pediatric Emergency Medicine, Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier:
NCT03360643
Other Study ID Numbers:
  • 1711-153
First Posted:
Dec 4, 2017
Last Update Posted:
Aug 4, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Kelly Bergmann, DO, MS, Emergency Research Director, Pediatric Emergency Medicine, Children's Hospitals and Clinics of Minnesota
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 4, 2021