<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/NCT04429698</url>
  </required_header>
  <id_info>
    <org_study_id>05 of 12.09.2018</org_study_id>
    <nct_id>NCT04429698</nct_id>
  </id_info>
  <brief_title>The Effects of Point-of-care Ultrasonography</brief_title>
  <official_title>The Effects of Point-of-care Ultrasonography on the Dıagnosıs Process of Patıents Who Admıtted to Emergency Department: Randomised-Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sakarya University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sakarya University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: When used with standard diagnostic testing, point-of-care ultrasonography (POCUS)&#xD;
      might improve the proportion of patients admitted with chest pain (CP) who are correctly&#xD;
      diagnosed, decrease length of stay (LOS) in emergency department (ED) and costs. We therefore&#xD;
      assessed POCUS for the heart, lungs, aortic, hepatobiliary and deep vein in addition to the&#xD;
      usual initial diagnostic testing in this patient population.&#xD;
&#xD;
      Methods: In a prospective, randomised-controlled, parallel-group trial in the ED at Sakarya&#xD;
      University Training and Research Hospital, Turkey, patients (≥18 years) with CP were randomly&#xD;
      assigned in a 1:1 ratio to a standard diagnostic strategy (control group) or to standard&#xD;
      diagnostic strategy supplemented with POCUS (POCUS group).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2018</start_date>
  <completion_date type="Actual">January 15, 2019</completion_date>
  <primary_completion_date type="Actual">January 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of hospitalization or discharge</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Average costs during the diagnosis of patients.</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The rate of change in the preliminary diagnosis of physician</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Hospitalization rate</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The discharge rate</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">208</enrollment>
  <condition>Chest Pain</condition>
  <arm_group>
    <arm_group_label>POCUS group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients in this group underwent POCUS after primary clinical evaluation with the knowledge of their primary physician. This procedure was performed in the first hour after the patients' primary clinical evaluations to evaluate the predetermined parameters in the study form for the heart, lungs, hepatobiliary, aortic and deep veins.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All processes and results were followed without any intervention in the processes related to the patients in this group and the results were recorded in the study form</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Point of care ultrasonography</intervention_name>
    <description>Point-of-care Ultrasonography is an imaging method performed with ultrasound aid to facilitate rapid diagnosis and interventions during emergency intervention.</description>
    <arm_group_label>POCUS group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted to the emergency were included in this study if they had chest pain,&#xD;
             or chest pain with back pain, neck and jaw pain, abdominal pain, arm pain and&#xD;
             shortness of breath&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  permanent mental disability&#xD;
&#xD;
          -  age younger than 18 years&#xD;
&#xD;
          -  having chest trauma in the last 24 hours&#xD;
&#xD;
          -  to be pregnant&#xD;
&#xD;
          -  need for urgent angiography with ST elevation myocardial infarction&#xD;
&#xD;
          -  to be referred to the ED as a diagnosis of external center&#xD;
&#xD;
          -  failure to obtain complete patient information&#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>Necip G Guner, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sakarya University Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sakarya University Training and Research Hospital</name>
      <address>
        <city>Sakarya</city>
        <zip>54050</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Buhumaid RE, St-Cyr Bourque J, Shokoohi H, Ma IWY, Longacre M, Liteplo AS. Integrating point-of-care ultrasound in the ED evaluation of patients presenting with chest pain and shortness of breath. Am J Emerg Med. 2019 Feb;37(2):298-303. doi: 10.1016/j.ajem.2018.10.059. Epub 2018 Oct 30.</citation>
    <PMID>30413369</PMID>
  </reference>
  <results_reference>
    <citation>Laursen CB, Sloth E, Lassen AT, Christensen Rd, Lambrechtsen J, Madsen PH, Henriksen DP, Davidsen JR, Rasmussen F. Point-of-care ultrasonography in patients admitted with respiratory symptoms: a single-blind, randomised controlled trial. Lancet Respir Med. 2014 Aug;2(8):638-46. doi: 10.1016/S2213-2600(14)70135-3. Epub 2014 Jul 3.</citation>
    <PMID>24998674</PMID>
  </results_reference>
  <results_reference>
    <citation>Lamsam L, Gharahbaghian L, Lobo V. Point-of-care Ultrasonography for Detecting the Etiology of Unexplained Acute Respiratory and Chest Complaints in the Emergency Department: A Prospective Analysis. Cureus. 2018 Aug 28;10(8):e3218. doi: 10.7759/cureus.3218.</citation>
    <PMID>30405993</PMID>
  </results_reference>
  <results_reference>
    <citation>Elikashvili I, Tay ET, Tsung JW. The effect of point-of-care ultrasonography on emergency department length of stay and computed tomography utilization in children with suspected appendicitis. Acad Emerg Med. 2014 Feb;21(2):163-70. doi: 10.1111/acem.12319.</citation>
    <PMID>24673672</PMID>
  </results_reference>
  <results_reference>
    <citation>Lin MJ, Neuman M, Rempell R, Monuteaux M, Levy J. Point-of-Care Ultrasound is Associated With Decreased Length of Stay in Children Presenting to the Emergency Department With Soft Tissue Infection. J Emerg Med. 2018 Jan;54(1):96-101. doi: 10.1016/j.jemermed.2017.09.017. Epub 2017 Oct 27.</citation>
    <PMID>29110982</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sakarya University</investigator_affiliation>
    <investigator_full_name>Necip Gökhan Güner</investigator_full_name>
    <investigator_title>Principial Investigator</investigator_title>
  </responsible_party>
  <keyword>chest pain, POCUS, length of stay, emergency department</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chest Pain</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/NCT04429698
org study id: 05 of 12.09.2018
nct id: NCT04429698
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Background: When used with standard diagnostic testing, point-of-care ultrasonography (POCUS)
      might improve the proportion of patients admitted with chest pain (CP) who are correctly
      diagnosed, decrease length of stay (LOS) in emergency department (ED) and costs. We therefore
      assessed POCUS for the heart, lungs, aortic, hepatobiliary and deep vein in addition to the
      usual initial diagnostic testing in this patient population.

      Methods: In a prospective, randomised-controlled, parallel-group trial in the ED at Sakarya
      University Training and Research Hospital, Turkey, patients (≥18 years) with CP were randomly
      assigned in a 1:1 ratio to a standard diagnostic strategy (control group) or to standard
      diagnostic strategy supplemented with POCUS (POCUS group).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Participant, Outcomes Assessor)
measure: Duration of hospitalization or discharge
time frame: 6 months
measure: Average costs during the diagnosis of patients.
time frame: 6 months
measure: The rate of change in the preliminary diagnosis of physician
time frame: 6 months
measure: The Hospitalization rate
time frame: 6 months
measure: The discharge rate
time frame: 6 months
arm group label: POCUS group
arm group type: Other
description: Patients in this group underwent POCUS after primary clinical evaluation with the knowledge of their primary physician. This procedure was performed in the first hour after the patients' primary clinical evaluations to evaluate the predetermined parameters in the study form for the heart, lungs, hepatobiliary, aortic and deep veins.
arm group label: Control group
arm group type: No Intervention
description: All processes and results were followed without any intervention in the processes related to the patients in this group and the results were recorded in the study form
intervention type: Diagnostic Test
intervention name: Point of care ultrasonography
description: Point-of-care Ultrasonography is an imaging method performed with ultrasound aid to facilitate rapid diagnosis and interventions during emergency intervention.
arm group label: POCUS group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Necip G Guner, M.D.
role: Principal Investigator
affiliation: Sakarya University Training and Research Hospital
facility: 
country: Turkey
citation: Buhumaid RE, St-Cyr Bourque J, Shokoohi H, Ma IWY, Longacre M, Liteplo AS. Integrating point-of-care ultrasound in the ED evaluation of patients presenting with chest pain and shortness of breath. Am J Emerg Med. 2019 Feb;37(2):298-303. doi: 10.1016/j.ajem.2018.10.059. Epub 2018 Oct 30.
PMID: 30413369
citation: Laursen CB, Sloth E, Lassen AT, Christensen Rd, Lambrechtsen J, Madsen PH, Henriksen DP, Davidsen JR, Rasmussen F. Point-of-care ultrasonography in patients admitted with respiratory symptoms: a single-blind, randomised controlled trial. Lancet Respir Med. 2014 Aug;2(8):638-46. doi: 10.1016/S2213-2600(14)70135-3. Epub 2014 Jul 3.
PMID: 24998674
citation: Lamsam L, Gharahbaghian L, Lobo V. Point-of-care Ultrasonography for Detecting the Etiology of Unexplained Acute Respiratory and Chest Complaints in the Emergency Department: A Prospective Analysis. Cureus. 2018 Aug 28;10(8):e3218. doi: 10.7759/cureus.3218.
PMID: 30405993
citation: Elikashvili I, Tay ET, Tsung JW. The effect of point-of-care ultrasonography on emergency department length of stay and computed tomography utilization in children with suspected appendicitis. Acad Emerg Med. 2014 Feb;21(2):163-70. doi: 10.1111/acem.12319.
PMID: 24673672
citation: Lin MJ, Neuman M, Rempell R, Monuteaux M, Levy J. Point-of-Care Ultrasound is Associated With Decreased Length of Stay in Children Presenting to the Emergency Department With Soft Tissue Infection. J Emerg Med. 2018 Jan;54(1):96-101. doi: 10.1016/j.jemermed.2017.09.017. Epub 2017 Oct 27.
PMID: 29110982
responsible party type: Principal Investigator
investigator affiliation: Sakarya University
investigator full name: Necip Gökhan Güner
investigator title: Principial Investigator
mesh term: Chest Pain
sharing ipd: No