<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02190981</url>
  </required_header>
  <id_info>
    <org_study_id>615362-1</org_study_id>
    <nct_id>NCT02190981</nct_id>
  </id_info>
  <brief_title>Point of Care Ultrasound for Suspected Small Bowel Obstruction in the Emergency Department</brief_title>
  <official_title>Point of Care Ultrasound for Suspected Small Bowel Obstruction in the Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>WellSpan Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, Irvine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Christiana Care Health Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>WellSpan Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to determine the accuracy of ultrasound in diagnosing&#xD;
      small bowel obstruction in emergency department patients, as compared to the criterion&#xD;
      standards of computed tomography, operative reports, or discharge diagnosis.&#xD;
&#xD;
      The secondary purposes of the study include evaluation of the effect of ultrasound for small&#xD;
      bowel obstruction on the patient length of stay in the emergency department and the&#xD;
      diagnostic utility of specific ultrasound findings in the diagnosis of small bowel&#xD;
      obstruction. The study will also examine the inter-rater agreement between point-of-care&#xD;
      sonographers' interpretation and blinded reviewers' interpretation of the ultrasound images.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      An estimated 15% of emergency department (ED) patients admitted to a surgical unit with&#xD;
      abdominal pain are ultimately diagnosed with small bowel obstruction (SBO) (1). The work up&#xD;
      of patients with possible SBO is directed by the patient history, physical examination and&#xD;
      pre-test probability. Relatively insensitive abdominal x-rays (AXR) are commonly ordered as a&#xD;
      screening test, but computed tomography (CT) imaging is often necessary to confirm or exclude&#xD;
      the diagnosis of SBO. This diagnostic process is time consuming, costly and exposes the&#xD;
      patient to ionizing radiation.&#xD;
&#xD;
      Interest in point-of-care (POC) ultrasonography (US) for the evaluation of suspected SBO has&#xD;
      increased in recent years. A growing body of literature suggests US is more sensitive and&#xD;
      specific compared to AXR in the diagnosis of SBO (1-3). US also confers the benefits of less&#xD;
      radiation exposure and more rapid decision-making. CT is generally considered the diagnostic&#xD;
      criterion standard for SBO, but effective use of POC US may reduce the need for CT imaging&#xD;
      and expedite the care of patients with suspected SBO.&#xD;
&#xD;
      Currently, there are five emergency physicians (EP) on staff in the York Hospital ED who are&#xD;
      fellowship trained in POC US. These physicians are fully credentialed and are already&#xD;
      performing ED based evaluations for small bowel obstruction. We intend to evaluate the&#xD;
      performance of EP-performed POC US in the diagnosis of SBO in ED patients. This study would&#xD;
      primarily investigate the accuracy of ultrasound as compared to the criterion standard of&#xD;
      abdominal CT results, intraoperative diagnosis, or discharge diagnosis.&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      This will be a prospective, observational study of adult ED patients suspected of having a&#xD;
      SBO. ED nurses, residents, and attendings will perform the initial screening for potential&#xD;
      enrollees. Once consented and enrolled, a study sonographer will interview and examine the&#xD;
      patient, preferably before labs and AXR results. The ultrasound must be completed and&#xD;
      adequate images obtained before advanced imaging modalities are completed. Ultrasound of all&#xD;
      four abdominal quadrants will be performed using the &quot;mowing the lawn&quot; technique described&#xD;
      previously in the literature (4).&#xD;
&#xD;
      The ultrasounds will be performed by all five of the US fellowship-trained EPs on staff, as&#xD;
      well as two current emergency ultrasound fellows and three emergency medicine residents. All&#xD;
      will participate in the identification, consent, and enrollment of patients in the study.&#xD;
&#xD;
      Trainees will undergo an hour-long educational session on POC US for SBO involving both&#xD;
      lectures and hands on training. Methods for proper consent and data collection will be&#xD;
      included. Blinded review of each ultrasound is already planned as a component of the study&#xD;
      design and treatment decisions will not be made based on trainees ultrasounds unless&#xD;
      supervised by a credentialed faculty member. The five faculty EP sonographers are already&#xD;
      fully credentialed in POC ultrasound and familiar with the technique for SBO. No additional&#xD;
      ultrasound training will be required for these participants.&#xD;
&#xD;
      A &quot;Bedside&quot; standardized data collection form will be used at the bedside to record&#xD;
      ultrasound findings and clinical information. The sonographer will designate the ultrasound&#xD;
      as &quot;positive for small bowel obstruction,&quot; &quot;negative for small bowel obstruction,&quot; or&#xD;
      &quot;indeterminate&quot; based on the exam and ultrasound findings.&#xD;
&#xD;
      A second sonographer, blinded to all clinical information and the primary sonographer's&#xD;
      ultrasound interpretation, will review the de-identified ultrasound images remotely. This&#xD;
      over-reading sonographer will record his interpretation and secondary findings on a &quot;Blinded&#xD;
      Reviewer&quot; standardized data collection sheet. Only fully credentialed, fellowship-trained EPs&#xD;
      will serve as secondary, blinded reviewers. Current fellows and residents involved in the&#xD;
      study will not review ultrasound images in this capacity.&#xD;
&#xD;
      CT imaging, intraoperative reports, and discharge diagnosis will be utilized to determine&#xD;
      final outcome of patient's clinical course. At this time, a third &quot;Follow Up&quot; standardized&#xD;
      data collection sheet will be used to record patient outcomes and demographic information.&#xD;
&#xD;
      In general, CT reports will be used as the criterion standard to which POC US findings will&#xD;
      be compared and by which sensitivity/specificity will be calculated. If no CT is obtained,&#xD;
      then operative report(s) will serve as the criterion standard. If the patient does not&#xD;
      receive CT imaging or undergo surgical intervention, then the discharge diagnosis will serve&#xD;
      as the criterion standard.&#xD;
&#xD;
      Study population and recruitment methods:&#xD;
&#xD;
      The study population will include adult patients presenting to the emergency department with&#xD;
      abdominal pain and a clinical suspicion of SBO. A treating attending physician or resident&#xD;
      will evaluate the patient. If there is a concern for SBO, the treating physician will contact&#xD;
      one of the ultrasound credentialed EP sonographers to perform a POC US to evaluate for&#xD;
      possible SBO. This process is the current practice standard in the ED.&#xD;
&#xD;
      At this point, the EP sonographer will approach the patient regarding the study. If the&#xD;
      patient agrees to participate, the EP sonographer will obtain informed consent. Of note, the&#xD;
      patient's treatment is unchanged, regardless of whether or not he/she consents to&#xD;
      participation in the study. The POC US will be obtained in either case, as this is standard&#xD;
      clinical practice in the ED. Agreeing to participate will simply allow the study team to&#xD;
      collect data and review their chart upon discharge from the hospital. The study sonographer&#xD;
      will obtain consent.&#xD;
&#xD;
      Data to be collected:&#xD;
&#xD;
      The following data will be recorded:&#xD;
&#xD;
        -  Patients initials&#xD;
&#xD;
        -  Patient Medical Record Number (MRN)/Financial Number (FIN)&#xD;
&#xD;
        -  Age&#xD;
&#xD;
        -  Sex&#xD;
&#xD;
        -  Height&#xD;
&#xD;
        -  Weight&#xD;
&#xD;
        -  Chief complaint&#xD;
&#xD;
        -  Presence/location of abdominal pain&#xD;
&#xD;
        -  Symptom duration&#xD;
&#xD;
        -  Associated symptoms (i.e. nausea/vomiting, diarrhea, etc.)&#xD;
&#xD;
        -  Visualization of the small bowel?&#xD;
&#xD;
        -  Maximum inner diameter of the small bowel?&#xD;
&#xD;
        -  Presence of &quot;to-and-fro&quot; peristalsis?&#xD;
&#xD;
        -  Edema of the wall of the small bowel?&#xD;
&#xD;
        -  Presence of free fluid surrounding the small bowel?&#xD;
&#xD;
        -  Presence of sonographic transition point?&#xD;
&#xD;
        -  Diagnostic impression of the sonographer&#xD;
&#xD;
        -  Diagnostic impression of the blinded reviewer&#xD;
&#xD;
        -  XR findings&#xD;
&#xD;
        -  CT diagnosis&#xD;
&#xD;
        -  Operative report classification&#xD;
&#xD;
        -  Time of patient placement in ED bed&#xD;
&#xD;
        -  Time of consultation or ED discharge&#xD;
&#xD;
        -  Discharge diagnosis&#xD;
&#xD;
      Data analysis:&#xD;
&#xD;
      For the primary outcome, data will be used to calculate the sensitivity and specificity of&#xD;
      POC US for the diagnosis of SBO compared to the criterion standard of CT or operative report.&#xD;
&#xD;
      For secondary outcomes, likelihood ratios for specific ultrasound findings will be&#xD;
      determined. Inter-rater agreement between the bedside sonographer and the blinded reviewer&#xD;
      will be calculated using Cohen's kappa coefficient. Continuous, time-to-disposition data will&#xD;
      be compared utilizing a two-tailed t-test.&#xD;
&#xD;
      Statistical analysis will be performed using SPSS software (IBM, Armonk, NY).&#xD;
&#xD;
      Risks and risk management:&#xD;
&#xD;
      There are minimal risks to patients participating in this study since ultrasound is&#xD;
      non-invasive and known to be safe. There is a slight risk of the participants' privacy or&#xD;
      confidentiality being breached. Standard precautions will be taken to ensure privacy and&#xD;
      confidentiality is maintained during the study.&#xD;
&#xD;
      Benefits:&#xD;
&#xD;
      Patients whose ultrasound is highly suspicious for small bowel obstruction may be referred&#xD;
      directly to surgery without further imaging being performed. In these instances study&#xD;
      patients would benefit from reduced radiation exposure and faster referral for appropriate&#xD;
      surgical care. The results of this study may be used to improve future patient care.&#xD;
&#xD;
      Compensation / incentives and research-related costs:&#xD;
&#xD;
      No compensation will be given to the participants. There will be no research-related costs.&#xD;
&#xD;
      Alternative procedures:&#xD;
&#xD;
      Patients who refuse to participate in the study will not have the quality of their treatment&#xD;
      affected in any way.&#xD;
&#xD;
      Research materials, records, and confidentiality:&#xD;
&#xD;
      Research records will be stored in locked offices, filing cabinets, and computers using&#xD;
      password-protected encryption.&#xD;
&#xD;
      Subject informed consent:&#xD;
&#xD;
      We will seek documented informed consent and Heath Insurance Portability and Accountability&#xD;
      Act (HIPAA). ED patients meeting all of the inclusion and exclusion criteria will be asked if&#xD;
      they would like to participate in the study by a research sonographer at the time of the&#xD;
      ultrasound.&#xD;
&#xD;
      If the patient agrees to participate, the informed consent document will be given to them for&#xD;
      their review. If patient declines to participate they will continue their treatment course in&#xD;
      the Emergency Department.&#xD;
&#xD;
      References of relevant literature:&#xD;
&#xD;
        1. Taylor, Mark R. and Nadim Lalani. Adult Small Bowel Obstruction. Academic Emergency&#xD;
           Medicine. 2013; 20:528-544.&#xD;
&#xD;
        2. Jang, Timothy B, et al. Bedside Ultrasonography for the Detection of Small Bowel&#xD;
           Obstruction in the Emergency Department. Journal of Emergency Medicine. 2011;28:676-678.&#xD;
&#xD;
        3. Suri, S, et al. Comparative evaluation of plain films, ultrasound, and CT in the&#xD;
           diagnosis of intestinal obstruction. Acta Radiologica. 40(1999): 422-428.&#xD;
&#xD;
        4. Mallin, Mike and Matthew Dawson. Introduction to Bedside Ultrasound: Volume 2. Emergency&#xD;
           Ultrasound Solutions. 20 May 2013.&#xD;
&#xD;
        5. Ko, Tae, et al. Small Bowel Obstruction: Sonographic Evaluation. Radiology.&#xD;
           1993;188:649-653.&#xD;
&#xD;
        6. Ogata, Masaaki, James R. Mateer, and Robert E. Condon. Prospective Evaluation of&#xD;
           Abdominal Sonography for the Diagnosis of Bowel Obstruction. Annals of Surgery.&#xD;
           1996;223(3):237-241.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">February 2019</completion_date>
  <primary_completion_date type="Actual">February 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic Accuracy of Point-of-care Ultrasound for Small Bowel Obstruction</measure>
    <time_frame>2 years</time_frame>
    <description>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.&#xD;
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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence/Likelihood Ratios of Specific Sonographic Findings of Small Bowel Obstruction</measure>
    <time_frame>2 years</time_frame>
    <description>Specific sonographic findings include:&#xD;
Small bowel diameter &gt;25 mm&#xD;
&quot;To-and-Fro&quot; peristalsis&#xD;
Small bowel wall edema&#xD;
Presence of intrabdominal free fluid&#xD;
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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter-rater Agreement</measure>
    <time_frame>2 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Length of Stay/Time to Disposition</measure>
    <time_frame>2 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">217</enrollment>
  <condition>Small Bowel Obstruction</condition>
  <arm_group>
    <arm_group_label>Ultrasound for Small Bowel Obstruction</arm_group_label>
    <description>Emergency department patients undergoing point-of-care ultrasound to evaluate for suspected small bowel obstruction</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound for Small Bowel Obstruction</intervention_name>
    <description>Point-of-care ultrasound to evaluate emergency department patients for suspected small bowel obstruction</description>
    <arm_group_label>Ultrasound for Small Bowel Obstruction</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult emergency department patients at a university-affiliated, community teaching hospital&#xD;
        with suspected small bowel obstruction&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or greater&#xD;
&#xD;
          -  Abdominal pain with clinical suspicion for small bowel obstruction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 years of age&#xD;
&#xD;
          -  Lack of decision-making capacity or cannot provide consent&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Prisoners&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brent A Becker, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wellspan Health York Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California Irvine Medical Center</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christana Hospital</name>
      <address>
        <city>Wilmington</city>
        <state>Delaware</state>
        <zip>19899</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellspan Health York Hospital</name>
      <address>
        <city>York</city>
        <state>Pennsylvania</state>
        <zip>17403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Taylor MR, Lalani N. Adult small bowel obstruction. Acad Emerg Med. 2013 Jun;20(6):528-44. doi: 10.1111/acem.12150.</citation>
    <PMID>23758299</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>20732861</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10394872</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>8351327</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>8604902</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>April 24, 2019</last_update_submitted>
  <last_update_submitted_qc>April 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>WellSpan Health</investigator_affiliation>
    <investigator_full_name>Brent Becker</investigator_full_name>
    <investigator_title>Emergency Physician - Wellspan Health York Hospital</investigator_title>
  </responsible_party>
  <keyword>Small bowel obstruction</keyword>
  <keyword>Ultrasound</keyword>
  <keyword>Emergency department</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Obstruction</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02190981
org study id: 615362-1
nct id: NCT02190981
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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.
Background:

      An estimated 15% of emergency department (ED) patients admitted to a surgical unit with
      abdominal pain are ultimately diagnosed with small bowel obstruction (SBO) (1). The work up
      of patients with possible SBO is directed by the patient history, physical examination and
      pre-test probability. Relatively insensitive abdominal x-rays (AXR) are commonly ordered as a
      screening test, but computed tomography (CT) imaging is often necessary to confirm or exclude
      the diagnosis of SBO. This diagnostic process is time consuming, costly and exposes the
      patient to ionizing radiation.

      Interest in point-of-care (POC) ultrasonography (US) for the evaluation of suspected SBO has
      increased in recent years. A growing body of literature suggests US is more sensitive and
      specific compared to AXR in the diagnosis of SBO (1-3). US also confers the benefits of less
      radiation exposure and more rapid decision-making. CT is generally considered the diagnostic
      criterion standard for SBO, but effective use of POC US may reduce the need for CT imaging
      and expedite the care of patients with suspected SBO.

      Currently, there are five emergency physicians (EP) on staff in the York Hospital ED who are
      fellowship trained in POC US. These physicians are fully credentialed and are already
      performing ED based evaluations for small bowel obstruction. We intend to evaluate the
      performance of EP-performed POC US in the diagnosis of SBO in ED patients. This study would
      primarily investigate the accuracy of ultrasound as compared to the criterion standard of
      abdominal CT results, intraoperative diagnosis, or discharge diagnosis.

      Study design:

      This will be a prospective, observational study of adult ED patients suspected of having a
      SBO. ED nurses, residents, and attendings will perform the initial screening for potential
      enrollees. Once consented and enrolled, a study sonographer will interview and examine the
      patient, preferably before labs and AXR results. The ultrasound must be completed and
      adequate images obtained before advanced imaging modalities are completed. Ultrasound of all
      four abdominal quadrants will be performed using the "mowing the lawn" technique described
      previously in the literature (4).

      The ultrasounds will be performed by all five of the US fellowship-trained EPs on staff, as
      well as two current emergency ultrasound fellows and three emergency medicine residents. All
      will participate in the identification, consent, and enrollment of patients in the study.

      Trainees will undergo an hour-long educational session on POC US for SBO involving both
      lectures and hands on training. Methods for proper consent and data collection will be
      included. Blinded review of each ultrasound is already planned as a component of the study
      design and treatment decisions will not be made based on trainees ultrasounds unless
      supervised by a credentialed faculty member. The five faculty EP sonographers are already
      fully credentialed in POC ultrasound and familiar with the technique for SBO. No additional
      ultrasound training will be required for these participants.

      A "Bedside" standardized data collection form will be used at the bedside to record
      ultrasound findings and clinical information. The sonographer will designate the ultrasound
      as "positive for small bowel obstruction," "negative for small bowel obstruction," or
      "indeterminate" based on the exam and ultrasound findings.

      A second sonographer, blinded to all clinical information and the primary sonographer's
      ultrasound interpretation, will review the de-identified ultrasound images remotely. This
      over-reading sonographer will record his interpretation and secondary findings on a "Blinded
      Reviewer" standardized data collection sheet. Only fully credentialed, fellowship-trained EPs
      will serve as secondary, blinded reviewers. Current fellows and residents involved in the
      study will not review ultrasound images in this capacity.

      CT imaging, intraoperative reports, and discharge diagnosis will be utilized to determine
      final outcome of patient's clinical course. At this time, a third "Follow Up" standardized
      data collection sheet will be used to record patient outcomes and demographic information.

      In general, CT reports will be used as the criterion standard to which POC US findings will
      be compared and by which sensitivity/specificity will be calculated. If no CT is obtained,
      then operative report(s) will serve as the criterion standard. If the patient does not
      receive CT imaging or undergo surgical intervention, then the discharge diagnosis will serve
      as the criterion standard.

      Study population and recruitment methods:

      The study population will include adult patients presenting to the emergency department with
      abdominal pain and a clinical suspicion of SBO. A treating attending physician or resident
      will evaluate the patient. If there is a concern for SBO, the treating physician will contact
      one of the ultrasound credentialed EP sonographers to perform a POC US to evaluate for
      possible SBO. This process is the current practice standard in the ED.

      At this point, the EP sonographer will approach the patient regarding the study. If the
      patient agrees to participate, the EP sonographer will obtain informed consent. Of note, the
      patient's treatment is unchanged, regardless of whether or not he/she consents to
      participation in the study. The POC US will be obtained in either case, as this is standard
      clinical practice in the ED. Agreeing to participate will simply allow the study team to
      collect data and review their chart upon discharge from the hospital. The study sonographer
      will obtain consent.

      Data to be collected:

      The following data will be recorded:

        -  Patients initials

        -  Patient Medical Record Number (MRN)/Financial Number (FIN)

        -  Age

        -  Sex

        -  Height

        -  Weight

        -  Chief complaint

        -  Presence/location of abdominal pain

        -  Symptom duration

        -  Associated symptoms (i.e. nausea/vomiting, diarrhea, etc.)

        -  Visualization of the small bowel?

        -  Maximum inner diameter of the small bowel?

        -  Presence of "to-and-fro" peristalsis?

        -  Edema of the wall of the small bowel?

        -  Presence of free fluid surrounding the small bowel?

        -  Presence of sonographic transition point?

        -  Diagnostic impression of the sonographer

        -  Diagnostic impression of the blinded reviewer

        -  XR findings

        -  CT diagnosis

        -  Operative report classification

        -  Time of patient placement in ED bed

        -  Time of consultation or ED discharge

        -  Discharge diagnosis

      Data analysis:

      For the primary outcome, data will be used to calculate the sensitivity and specificity of
      POC US for the diagnosis of SBO compared to the criterion standard of CT or operative report.

      For secondary outcomes, likelihood ratios for specific ultrasound findings will be
      determined. Inter-rater agreement between the bedside sonographer and the blinded reviewer
      will be calculated using Cohen's kappa coefficient. Continuous, time-to-disposition data will
      be compared utilizing a two-tailed t-test.

      Statistical analysis will be performed using SPSS software (IBM, Armonk, NY).

      Risks and risk management:

      There are minimal risks to patients participating in this study since ultrasound is
      non-invasive and known to be safe. There is a slight risk of the participants' privacy or
      confidentiality being breached. Standard precautions will be taken to ensure privacy and
      confidentiality is maintained during the study.

      Benefits:

      Patients whose ultrasound is highly suspicious for small bowel obstruction may be referred
      directly to surgery without further imaging being performed. In these instances study
      patients would benefit from reduced radiation exposure and faster referral for appropriate
      surgical care. The results of this study may be used to improve future patient care.

      Compensation / incentives and research-related costs:

      No compensation will be given to the participants. There will be no research-related costs.

      Alternative procedures:

      Patients who refuse to participate in the study will not have the quality of their treatment
      affected in any way.

      Research materials, records, and confidentiality:

      Research records will be stored in locked offices, filing cabinets, and computers using
      password-protected encryption.

      Subject informed consent:

      We will seek documented informed consent and Heath Insurance Portability and Accountability
      Act (HIPAA). ED patients meeting all of the inclusion and exclusion criteria will be asked if
      they would like to participate in the study by a research sonographer at the time of the
      ultrasound.

      If the patient agrees to participate, the informed consent document will be given to them for
      their review. If patient declines to participate they will continue their treatment course in
      the Emergency Department.

      References of relevant literature:

        1. Taylor, Mark R. and Nadim Lalani. Adult Small Bowel Obstruction. Academic Emergency
           Medicine. 2013; 20:528-544.

        2. Jang, Timothy B, et al. Bedside Ultrasonography for the Detection of Small Bowel
           Obstruction in the Emergency Department. Journal of Emergency Medicine. 2011;28:676-678.

        3. Suri, S, et al. Comparative evaluation of plain films, ultrasound, and CT in the
           diagnosis of intestinal obstruction. Acta Radiologica. 40(1999): 422-428.

        4. Mallin, Mike and Matthew Dawson. Introduction to Bedside Ultrasound: Volume 2. Emergency
           Ultrasound Solutions. 20 May 2013.

        5. Ko, Tae, et al. Small Bowel Obstruction: Sonographic Evaluation. Radiology.
           1993;188:649-653.

        6. Ogata, Masaaki, James R. Mateer, and Robert E. Condon. Prospective Evaluation of
           Abdominal Sonography for the Diagnosis of Bowel Obstruction. Annals of Surgery.
           1996;223(3):237-241.
observational model: Cohort
time perspective: Prospective
measure: Diagnostic Accuracy of Point-of-care Ultrasound for Small Bowel Obstruction
time frame: 2 years
description: 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.
measure: Incidence/Likelihood Ratios of Specific Sonographic Findings of Small Bowel Obstruction
time frame: 2 years
description: 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)
measure: Inter-rater Agreement
time frame: 2 years
description: 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.
measure: Patient Length of Stay/Time to Disposition
time frame: 2 years
description: 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.
arm group label: Ultrasound for Small Bowel Obstruction
description: Emergency department patients undergoing point-of-care ultrasound to evaluate for suspected small bowel obstruction
intervention type: Device
intervention name: Ultrasound for Small Bowel Obstruction
description: Point-of-care ultrasound to evaluate emergency department patients for suspected small bowel obstruction
arm group label: Ultrasound for Small Bowel Obstruction
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brent A Becker, MD
role: Principal Investigator
affiliation: Wellspan Health York Hospital
facility: 
facility: 
facility: 
country: United States
citation: Taylor MR, Lalani N. Adult small bowel obstruction. Acad Emerg Med. 2013 Jun;20(6):528-44. doi: 10.1111/acem.12150.
PMID: 23758299
citation: 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
citation: 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
citation: 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
citation: 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
responsible party type: Principal Investigator
investigator affiliation: WellSpan Health
investigator full name: Brent Becker
investigator title: Emergency Physician - Wellspan Health York Hospital
mesh term: Intestinal Obstruction
mesh term: Emergencies
sharing ipd: No