IntussusceptionNCT03360643
Point-of-Care Ultrasonography for Intussusception
A study testing Point-of-care ultrasound prior to radiology ultrasound and Radiology-performed ultrasound in people with Intussusception and Emergencies, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Intussusception, Emergencies
- What is being tested?
- Point-of-care ultrasound prior to radiology ultrasound and Radiology-performed ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2017to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children 3 months through 6 years of age;
- Clinical suspicion for intussusception per treating emergency physician.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Point-of-Care Ultrasonography for Intussusception: A Randomized Noninferiority Trial
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.
Read the 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.
- Conditions
- Intussusception, Emergencies
- Being tested
- Point-of-care ultrasound prior to radiology ultrasound, Radiology-performed ultrasound
- Keywords
- Point-of-care ultrasound, Intussusception, Pediatric Emergency Medicine, Ultrasound
- Medical subject headings
- Intussusception, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care ultrasound prior to radiology ultrasoundDiagnostic test
Point-of-care ultrasound performed by pediatric emergency medicine physicians prior to radiology-performed ultrasound
Radiology-performed ultrasoundDiagnostic test
Ultrasound performed an ultrasound technician and/or radiologist, and interpreted by a radiologist
| Study group | Role | What they receive |
|---|---|---|
| Point-of-care ultrasound prior to radiology ultrasound | Active comparator | Not described Receives: Diagnostic Test: Point-of-care ultrasound prior to radiology ultrasound |
| Radiology-performed ultrasound | Active comparator | Not described Receives: Diagnostic Test: Radiology-performed ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of POCUS and RADUS for clinically important intussusception, expressed as sensitivity and specificity
Measured: 2 years from start of enrollment
Secondary outcomes (13)
Rates of recurrent intussusception
The number of patients with recurrent intussusception in each study arm
Measured: 2 years from start of enrollment
Rate of peritonitis
The number of patients with peritonitis in each study arm
Measured: 2 years from start of enrollment
Rate of bowel perforation
The number of patients with bowel perforation in each study arm
Measured: 2 years from start of enrollment
Rate of intestinal obstruction
The number of patients with intestinal obstruction in each study arm
Measured: 2 years from start of enrollment
Rate of shock
The number of patients with shock in each study arm
Measured: 2 years from start of enrollment
Rate of death
The number of deaths in each study arm
Measured: 2 years from start of enrollment
Emergency Department length of stay
Measured: 2 years from start of enrollment
Hospital length of stay (for patients admitted to the hospital)
Measured: 2 years from start of enrollment
Emergency Department laboratory investigations
The total number of laboratory investigations obtained per patient
Measured: 2 years from start of enrollment
Radiology studies
The total number of radiology studies obtained per patient
Measured: 2 years after start of enrollment
Emergency Department return visit at 3 days
Return ED visit 3 days after index ED visit
Measured: 3 days after the index ED visit
Emergency Department return visit at 7 days
Return ED visit 7 days after index ED visit
Measured: 7 days after the 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
Measured: 2 years from start of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start15 Nov 2017
- Primary completion31 Jul 2020
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for IntussusceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Bergmann, DO, MS, Children's Hospitals and Clinics of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360643
- Sponsor's protocol ID
- 1711-153
- Status last verified
- Aug 2023
- First submitted
- 20 Nov 2017
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Waseem M, Rosenberg HK. Intussusception. Pediatr Emerg Care. 2008 Nov;24(11):793-800. doi: 10.1097/PEC.0b013e31818c2a3e.
PubMed 19018227Hryhorczuk 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.
PubMed 19657636Daneman 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.
PubMed 12557062Daneman 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.
PubMed 14634696American 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.
PubMed 19303521Vieira 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.
PubMed 23517263Lam 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.
PubMed 25548597Riera 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.
PubMed 22424652Bhisitkul 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.
PubMed 1640281Verschelden 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.
PubMed 1509059Williams 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.
PubMed 18208983Ahn 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.
PubMed 23610094
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-Care Ultrasonography for Intussusception: A Randomized Noninferiority Trial
- ClinicalTrials.gov ID
- NCT03360643
- Acronym / sponsor ID
- 1711-153
- Conditions
- Intussusception, Emergencies
- Keywords
- Point-of-care ultrasound, Intussusception, Pediatric Emergency Medicine, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 4 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 3 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children 3 months through 6 years of age;
- Clinical suspicion for intussusception per treating emergency physician.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-care ultrasound prior to radiology ultrasoundPoint-of-care ultrasound performed by pediatric emergency medicine physicians prior to radiology-performed ultrasound | Diagnostic test | Point-of-care ultrasound prior to radiology ultrasound |
| Radiology-performed ultrasoundUltrasound performed an ultrasound technician and/or radiologist, and interpreted by a radiologist | Diagnostic test | Radiology-performed ultrasound |
Primary outcome
Diagnostic accuracy of POCUS and RADUS for clinically important intussusception, expressed as sensitivity and specificity
Time frame: 2 years from start of enrollment
13 secondary outcomes
Rates of recurrent intussusception
Time frame: 2 years from start of enrollment
Rate of peritonitis
Time frame: 2 years from start of enrollment
Rate of bowel perforation
Time frame: 2 years from start of enrollment
Rate of intestinal obstruction
Time frame: 2 years from start of enrollment
Rate of shock
Time frame: 2 years from start of enrollment
Rate of death
Time frame: 2 years from start of enrollment
Emergency Department length of stay
Time frame: 2 years from start of enrollment
Hospital length of stay (for patients admitted to the hospital)
Time frame: 2 years from start of enrollment
Emergency Department laboratory investigations
Time frame: 2 years from start of enrollment
Radiology studies
Time frame: 2 years after start of enrollment
Emergency Department return visit at 3 days
Time frame: 3 days after the index ED visit
Emergency Department return visit at 7 days
Time frame: 7 days after the index ED visit
Differentiation of ileocolic and ileoileal intussusception, measured in centimeters
Time frame: 2 years from start of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Background: PubMed 19018227Waseem M, Rosenberg HK. Intussusception. Pediatr Emerg Care. 2008 Nov;24(11):793-800. doi: 10.1097/PEC.0b013e31818c2a3e.
- Background: PubMed 19657636Hryhorczuk 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.
- Background: PubMed 12557062Daneman 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.
- Background: PubMed 14634696Daneman 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.
- Background: PubMed 19303521American 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.
- Background: PubMed 23517263Vieira 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.
- Background: PubMed 25548597Lam 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.
- Background: PubMed 22424652Riera 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.
- Background: PubMed 1640281Bhisitkul 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.
- Background: PubMed 1509059Verschelden 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.
- Background: PubMed 18208983Williams 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.
- Background: PubMed 23610094Ahn 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.
- Individual participant dataSharing planned: No
Related trials for Intussusception
Active, not recruitingObservational study
Clinical Outcomes of Rectopexy for Rectal Prolapse
Rectal Prolapse, Fecal Incontinence
Recruiting
Append Prague Study
Non Valvular Atrial Fibrillation
Recruiting
Applause Study I - Append System Early Feasibility Study
Non Valvular Atrial Fibrillation
Not yet recruiting
Benign Versus Malignant Causes of Intussuception in Adults
Intussusception (IS)
Not yet recruitingObservational study
Clinical Association Between Celiac Disease and Intussusception in Children
Celiac Disease in Children, Intussusception
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-care ultrasound prior to radiology ultrasound and Radiology-performed ultrasound in people with Intussusception and Emergencies, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of POCUS and RADUS for clinically important intussusception, expressed as sensitivity and specificity (time frame: 2 years from start of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03360643, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.