<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/NCT03296085</url>
  </required_header>
  <id_info>
    <org_study_id>2017-0434</org_study_id>
    <nct_id>NCT03296085</nct_id>
  </id_info>
  <brief_title>Bedside Evaluation of Edema</brief_title>
  <acronym>EDEMA</acronym>
  <official_title>A Simple Technique for Quantitative Evaluation of an Important Clinical Sign</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Geisinger Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Geisinger Clinic</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Edema, commonly called swelling, is a common medical condition, with many causes. Clinicians&#xD;
      generally find edema by pressing against a patient's skin, usually on the feet or shins, and&#xD;
      observing how much dimpling there is in the skin. Most clinicians estimate the amount on a&#xD;
      scale of mild to severe, or perhaps state the amount as 1 to 4. There is little agreement&#xD;
      between observers, and it is hard to judge different clinicians' use of these scales. The&#xD;
      first part of this experiment will demonstrate this inconsistency. After clinicians are shown&#xD;
      a new technique for measuring edema, the second part of the study will show more accurate and&#xD;
      consistent measurements. This will help clinicians to measure edema better, and to&#xD;
      communicate their findings to other clinicians more effectively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research team will recruit as many clinicians who are conveniently available for the&#xD;
      study. Clinicians will include attending physicians from any specialty, residents, medical&#xD;
      students, physician assistants, physician assistant students, nurses, certified nurse&#xD;
      practitioners, and certified nurse practitioner students.&#xD;
&#xD;
      Once patients and clinicians have been recruited, the research team will maintain a list of&#xD;
      the patients and a grid of which clinicians are to examine which patients. Each clinician&#xD;
      will be given a data collection sheet, listing the patients' room numbers, and a grid for&#xD;
      recording results for each of the patient's affected limb(s). The first data collection sheet&#xD;
      (before instruction on the quantitative method) will just show a blank free text field so&#xD;
      that clinicians can record their results as they normally do.&#xD;
&#xD;
      After instruction in the novel quantitative technique, the clinicians will receive another&#xD;
      data collection sheet now indicating the intent to have the clinicians record their findings&#xD;
      in millimeters.&#xD;
&#xD;
      The expectation is that a minimum of 6 examiners will determine the extent of edema on at&#xD;
      least 38 limbs. If possible, the research will continue until approximately 100 limbs have&#xD;
      been examined by a total of at least 10 to 20 clinicians.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Principle investigator changed academic affiliation, then later retired. Study terminated after&#xD;
    intra-observer validation, but inter-observer validation not completed.&#xD;
  </why_stopped>
  <start_date type="Actual">November 30, 2017</start_date>
  <completion_date type="Actual">December 30, 2022</completion_date>
  <primary_completion_date type="Actual">December 12, 2022</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>Inter-observer correlation of edema measurement before instruction in novel technique</measure>
    <time_frame>one day</time_frame>
    <description>Observe the variation in edema documentation based on standard examination technique</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inter-observer correlation of edema measurement after instruction in novel technique</measure>
    <time_frame>one day</time_frame>
    <description>Observe the variation in edema documentation based on the novel examination technique</description>
  </primary_outcome>
  <enrollment type="Actual">1</enrollment>
  <condition>Edema</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Exam for quantity of edema</intervention_name>
    <description>There is no intervention</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitalized patients with edema&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Currently admitted patients&#xD;
&#xD;
          -  Patient who can understand the purpose of the study and sign a consent form&#xD;
&#xD;
          -  Patient has a measurable amount of edema&#xD;
&#xD;
          -  Patient will likely be available during the time the clinicians can examine the&#xD;
             patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable or unwilling to sign the consent form&#xD;
&#xD;
          -  No measurable edema&#xD;
&#xD;
          -  Currently in isolation for infection control purposes&#xD;
&#xD;
          -  Patients in the Behavioral Health section of the hospital&#xD;
&#xD;
          -  Maternity patients (due to availability of infant rooming-in)&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Age below 18 years&#xD;
&#xD;
          -  Patients with bilateral lower extremity amputation&#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>Richard Schreiber, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Geisinger Holy Spirit</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Geisinger Holy Spirit</name>
      <address>
        <city>Camp Hill</city>
        <state>Pennsylvania</state>
        <zip>17011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://assets.researchsquare.com/files/rs-2362872/v1/d0a93eae-0bfd-41dc-932f-9539a4d25f34.pdf?c=1670868873</url>
    <description>Preprint of intraobserver reliability data at doi:10.21203/rs.3.rs-2362872/v1</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>June 26, 2023</last_update_submitted>
  <last_update_submitted_qc>June 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Geisinger Clinic</investigator_affiliation>
    <investigator_full_name>Richard Schreiber, MD FACP</investigator_full_name>
    <investigator_title>Chief Medical Informatics Officer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Edema</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/NCT03296085
org study id: 2017-0434
nct id: NCT03296085
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Edema, commonly called swelling, is a common medical condition, with many causes. Clinicians
      generally find edema by pressing against a patient's skin, usually on the feet or shins, and
      observing how much dimpling there is in the skin. Most clinicians estimate the amount on a
      scale of mild to severe, or perhaps state the amount as 1 to 4. There is little agreement
      between observers, and it is hard to judge different clinicians' use of these scales. The
      first part of this experiment will demonstrate this inconsistency. After clinicians are shown
      a new technique for measuring edema, the second part of the study will show more accurate and
      consistent measurements. This will help clinicians to measure edema better, and to
      communicate their findings to other clinicians more effectively.
The research team will recruit as many clinicians who are conveniently available for the
      study. Clinicians will include attending physicians from any specialty, residents, medical
      students, physician assistants, physician assistant students, nurses, certified nurse
      practitioners, and certified nurse practitioner students.

      Once patients and clinicians have been recruited, the research team will maintain a list of
      the patients and a grid of which clinicians are to examine which patients. Each clinician
      will be given a data collection sheet, listing the patients' room numbers, and a grid for
      recording results for each of the patient's affected limb(s). The first data collection sheet
      (before instruction on the quantitative method) will just show a blank free text field so
      that clinicians can record their results as they normally do.

      After instruction in the novel quantitative technique, the clinicians will receive another
      data collection sheet now indicating the intent to have the clinicians record their findings
      in millimeters.

      The expectation is that a minimum of 6 examiners will determine the extent of edema on at
      least 38 limbs. If possible, the research will continue until approximately 100 limbs have
      been examined by a total of at least 10 to 20 clinicians.
observational model: Cohort
time perspective: Prospective
measure: Inter-observer correlation of edema measurement before instruction in novel technique
time frame: one day
description: Observe the variation in edema documentation based on standard examination technique
measure: Inter-observer correlation of edema measurement after instruction in novel technique
time frame: one day
description: Observe the variation in edema documentation based on the novel examination technique
intervention type: Procedure
intervention name: Exam for quantity of edema
description: There is no intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Richard Schreiber, MD
role: Principal Investigator
affiliation: Geisinger Holy Spirit
facility: 
country: United States
url: https://assets.researchsquare.com/files/rs-2362872/v1/d0a93eae-0bfd-41dc-932f-9539a4d25f34.pdf?c=1670868873
description: Preprint of intraobserver reliability data at doi:10.21203/rs.3.rs-2362872/v1
responsible party type: Principal Investigator
investigator affiliation: Geisinger Clinic
investigator full name: Richard Schreiber, MD FACP
investigator title: Chief Medical Informatics Officer
mesh term: Edema
sharing ipd: No