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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
Sponsor:
Collaborators:
University of California, Irvine
Christiana Care Health Services
Information provided by (Responsible Party):
Brent Becker, WellSpan Health

Brief Summary:

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

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 217 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult emergency department patients at a university-affiliated, community teaching hospital with suspected small bowel obstruction
Criteria

Inclusion Criteria:

  • 18 years of age or greater
  • Abdominal pain with clinical suspicion for small bowel obstruction

Exclusion Criteria:

  • Less than 18 years of age
  • Lack of decision-making capacity or cannot provide consent
  • Pregnancy
  • Prisoners

Information from the National Library of Medicine

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


Locations
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United States, California
University of California Irvine Medical Center
Orange, California, United States, 92868
United States, Delaware
Christana Hospital
Wilmington, Delaware, United States, 19899
United States, Pennsylvania
Wellspan Health York Hospital
York, Pennsylvania, United States, 17403
Sponsors and Collaborators
WellSpan Health
University of California, Irvine
Christiana Care Health Services
Investigators
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Principal Investigator: Brent A Becker, MD Wellspan Health York Hospital

Publications:
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Responsible Party: Brent Becker, Emergency Physician - Wellspan Health York Hospital, WellSpan Health
ClinicalTrials.gov Identifier: NCT02190981     History of Changes
Other Study ID Numbers: 615362-1
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Brent Becker, WellSpan Health:
Small bowel obstruction
Ultrasound
Emergency department
Additional relevant MeSH terms:
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Intestinal Obstruction
Emergencies
Disease Attributes
Pathologic Processes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases