Point of Care Ultrasound for Suspected Small Bowel Obstruction in the Emergency Department

NCT02190981 | Completed

• 1 other identifier: 615362-1
• Study Type: observational
• Target: 217
• Locations: 1 country
• Sites: 3

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.

Conditions

Small Bowel Obstruction

Keywords

Small bowel obstruction; Ultrasound; Emergency department

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of Point-of-care Ultrasound for Small Bowel Obstruction

  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.

  2 years

Secondary Outcomes (3)

• Incidence/Likelihood Ratios of Specific Sonographic Findings of Small Bowel Obstruction

  2 years

• Inter-rater Agreement

  2 years

• Patient Length of Stay/Time to Disposition

  2 years

Study Arms (1)

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

Interventions

Ultrasound for Small Bowel Obstruction DEVICE

Point-of-care ultrasound to evaluate emergency department patients for suspected small bowel obstruction

Ultrasound for Small Bowel Obstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult emergency department patients at a university-affiliated, community teaching hospital with suspected small bowel obstruction

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• WellSpan Health: lead
• University of California, Irvine: collaborator
• Christiana Care Health Services: collaborator

Study Sites (3)

University of California Irvine Medical Center

Orange, California, 92868, United States

Location

Christana Hospital

Wilmington, Delaware, 19899, United States

Location

Wellspan Health York Hospital

York, Pennsylvania, 17403, United States

Location

Related Publications (6)

• Taylor MR, Lalani N. Adult small bowel obstruction. Acad Emerg Med. 2013 Jun;20(6):528-44. doi: 10.1111/acem.12150.

  PMID: 23758299 BACKGROUND

• Jang TB, Schindler D, Kaji AH. Bedside ultrasonography for the detection of small bowel obstruction in the emergency department. Emerg Med J. 2011 Aug;28(8):676-8. doi: 10.1136/emj.2010.095729. Epub 2010 Aug 22.

  PMID: 20732861 BACKGROUND

• Suri S, Gupta S, Sudhakar PJ, Venkataramu NK, Sood B, Wig JD. Comparative evaluation of plain films, ultrasound and CT in the diagnosis of intestinal obstruction. Acta Radiol. 1999 Jul;40(4):422-8. doi: 10.3109/02841859909177758.

  PMID: 10394872 BACKGROUND

• Ko YT, Lim JH, Lee DH, Lee HW, Lim JW. Small bowel obstruction: sonographic evaluation. Radiology. 1993 Sep;188(3):649-53. doi: 10.1148/radiology.188.3.8351327.

  PMID: 8351327 BACKGROUND

• Ogata M, Mateer JR, Condon RE. Prospective evaluation of abdominal sonography for the diagnosis of bowel obstruction. Ann Surg. 1996 Mar;223(3):237-41. doi: 10.1097/00000658-199603000-00002.

  PMID: 8604902 BACKGROUND

• Becker BA, Lahham S, Gonzales MA, Nomura JT, Bui MK, Truong TA, Stahlman BA, Fox JC, Kehrl T. A Prospective, Multicenter Evaluation of Point-of-care Ultrasound for Small-bowel Obstruction in the Emergency Department. Acad Emerg Med. 2019 Aug;26(8):921-930. doi: 10.1111/acem.13713. Epub 2019 Mar 12.

  PMID: 30762916 DERIVED

MeSH Terms

Conditions

Emergencies

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Brent A Becker, MD

  Wellspan Health York Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Physician - Wellspan Health York Hospital

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 15, 2014
• Study Start: July 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2019
• Last Updated: April 26, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)