Emergencies Clinical Trial
Official title:
Point-of-Care Ultrasonography for Intussusception: A Randomized Noninferiority Trial
Verified date | August 2023 |
Source | Children's Hospitals and Clinics of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Children's Hospitals and Clinics of Minnesota |
United States,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05552989 -
Towards Better Preparedness for Future Catastrophes - Local Lessons-learned From COVID-19
|
||
Not yet recruiting |
NCT04915690 -
Investigation on the Practice Status of Emergency Stuff
|
||
Not yet recruiting |
NCT03424096 -
Primary Palliative Care Education, Training, and Technical Support for Emergency Medicine
|
N/A | |
Completed |
NCT02534324 -
The Effect of Pre-discharge Blood Pressure of Patients With Asymptomatic Severe Hypertension in Emergency Department
|
N/A | |
Completed |
NCT00991471 -
The Effect of an Physician-Nurse Supplementary Triage Assistance Team on Emergency Department Patient Wait Times
|
N/A | |
Recruiting |
NCT03257319 -
Inhaled vs IV Opioid Dosing for the Initial Treatment of Severe Acute Pain in the Emergency Department
|
Phase 3 | |
Recruiting |
NCT05005117 -
Laparoscopic Approach for Emergency Colon Resection
|
N/A | |
Recruiting |
NCT03917368 -
Ultrasound Evaluation of the Jugular Venous Pulse (US-JVP)
|
N/A | |
Completed |
NCT04601922 -
Qualitative Study of Long Term Cardiovascular Risk Prediction in the Emergency Department
|
||
Recruiting |
NCT05497830 -
Machine Learning for Risk Stratification in the Emergency Department (MARS-ED)
|
N/A | |
Active, not recruiting |
NCT06220916 -
The Greek Acute Dance Injuries Registry
|
||
Recruiting |
NCT05496114 -
Medical Checklists in the Emergency Department
|
N/A | |
Recruiting |
NCT06072534 -
Evaluation of Effectiveness of Two Different Doses of Mivacurium in Rapid Sequence Intubation
|
N/A | |
Recruiting |
NCT05543772 -
Evaluation of Blood Sampling From a Pre-existed Peripheral Intravenous Catheter Line
|
Phase 4 | |
Not yet recruiting |
NCT05528211 -
Safety and Efficacy of Emergent TAVI in Patients With Severe AS
|
||
Completed |
NCT05818215 -
Impact of the Qatar 2022 FIFA World Cup on PED Use and Misuse Patterns
|
||
Recruiting |
NCT04615065 -
Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine
|
||
Active, not recruiting |
NCT05221697 -
Effect of an ML Electronic Alert Management System to Reduce the Use of ED Visits and Hospitalizations
|
N/A | |
Active, not recruiting |
NCT04648449 -
Artificial Intelligence (AI) Support in Medical Emergency Calls
|
||
Not yet recruiting |
NCT04431986 -
ER2 Frailty Levels and Incident Adverse Health Events in Older Community Dwellers
|