Point of Care Ultrasound for Suspected Small Bowel Obstruction in the Emergency Department
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|ClinicalTrials.gov Identifier: NCT02190981|
Recruitment Status : Completed
First Posted : July 15, 2014
Last Update Posted : April 26, 2019
The primary purpose of this study is to determine the accuracy of ultrasound in diagnosing small bowel obstruction in emergency department patients, as compared to the criterion standards of computed tomography, operative reports, or discharge diagnosis.
The secondary purposes of the study include evaluation of the effect of ultrasound for small bowel obstruction on the patient length of stay in the emergency department and the diagnostic utility of specific ultrasound findings in the diagnosis of small bowel obstruction. The study will also examine the inter-rater agreement between point-of-care sonographers' interpretation and blinded reviewers' interpretation of the ultrasound images.
|Condition or disease||Intervention/treatment|
|Small Bowel Obstruction||Device: Ultrasound for Small Bowel Obstruction|
|Study Type :||Observational|
|Actual Enrollment :||217 participants|
|Official Title:||Point of Care Ultrasound for Suspected Small Bowel Obstruction in the Emergency Department|
|Actual Study Start Date :||July 2014|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||February 2019|
Ultrasound for Small Bowel Obstruction
Emergency department patients undergoing point-of-care ultrasound to evaluate for suspected small bowel obstruction
Device: Ultrasound for Small Bowel Obstruction
Point-of-care ultrasound to evaluate emergency department patients for suspected small bowel obstruction
- Diagnostic Accuracy of Point-of-care Ultrasound for Small Bowel Obstruction [ Time Frame: 2 years ]
The performance of point-of-care ultrasound for small bowel obstruction will be evaluated by comparing each ultrasound to the criterion standard of computed tomography (CT) for each enrolled patient. If a CT is not obtained, then operative report/findings or discharge diagnosis will be used as the criterion standard to which the ultrasound will be compared.
Using the criterion standard as the definitive diagnosis for each patient (i.e. presence or absence of small bowel obstruction), each ultrasound will be classified as a true positive, true negative, false positive or false negative. This data will be used to calculated the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of point-of-care ultrasound for the diagnosis of small bowel obstruction.
- Incidence/Likelihood Ratios of Specific Sonographic Findings of Small Bowel Obstruction [ Time Frame: 2 years ]
Specific sonographic findings include:
- Small bowel diameter >25 mm
- "To-and-Fro" peristalsis
- Small bowel wall edema
- Presence of intrabdominal free fluid
- Presence of sonographic transition point (defined as the location between dilated small bowel proximal to the obstruction and decompressed small bowel distal to the obstruction)
- Inter-rater Agreement [ Time Frame: 2 years ]The study will quantify the rate of inter-rater agreement between the clinician performing the point-of-care ultrasound and a blinded reviewer of the ultrasound images.
- Patient Length of Stay/Time to Disposition [ Time Frame: 2 years ]The study will measure the time to disposition of ED patients undergoing a point of care ultrasound for small bowel obstruction and determine how the ultrasound effects time to patient disposition.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02190981
|United States, California|
|University of California Irvine Medical Center|
|Orange, California, United States, 92868|
|United States, Delaware|
|Wilmington, Delaware, United States, 19899|
|United States, Pennsylvania|
|Wellspan Health York Hospital|
|York, Pennsylvania, United States, 17403|
|Principal Investigator:||Brent A Becker, MD||Wellspan Health York Hospital|