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NCT Number: NCT03360643

Point-of-Care Ultrasonography for Intussusception

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.

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Key information

Age range

3 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Minnesota

Minneapolis, Minnesota, 55404, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Point-of-care ultrasound prior to radiology ultrasound

Diagnostic Test

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

Radiology-performed ultrasound

Diagnostic Test

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

Primary outcomes

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

    Time frame: 2 years from start of enrollment

Secondary outcomes

  1. Rates of recurrent intussusception

    Time frame: 2 years from start of enrollment

    The number of patients with recurrent intussusception in each study arm

  2. Rate of peritonitis

    Time frame: 2 years from start of enrollment

    The number of patients with peritonitis in each study arm

  3. Rate of bowel perforation

    Time frame: 2 years from start of enrollment

    The number of patients with bowel perforation in each study arm

  4. Rate of intestinal obstruction

    Time frame: 2 years from start of enrollment

    The number of patients with intestinal obstruction in each study arm

  5. Rate of shock

    Time frame: 2 years from start of enrollment

    The number of patients with shock in each study arm

  6. Rate of death

    Time frame: 2 years from start of enrollment

    The number of deaths in each study arm

  7. Emergency Department length of stay

    Time frame: 2 years from start of enrollment

  8. Hospital length of stay (for patients admitted to the hospital)

    Time frame: 2 years from start of enrollment

  9. Emergency Department laboratory investigations

    Time frame: 2 years from start of enrollment

    The total number of laboratory investigations obtained per patient

  10. Radiology studies

    Time frame: 2 years after start of enrollment

    The total number of radiology studies obtained per patient

  11. Emergency Department return visit at 3 days

    Time frame: 3 days after the index ED visit

    Return ED visit 3 days after index ED visit

  12. Emergency Department return visit at 7 days

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Children's Hospitals and Clinics of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Dec 4, 2017
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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