<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/NCT02208895</url>
  </required_header>
  <id_info>
    <org_study_id>3785</org_study_id>
    <secondary_id>VAMC OKC</secondary_id>
    <nct_id>NCT02208895</nct_id>
  </id_info>
  <brief_title>iSTAT Comparison Study, IRB3785</brief_title>
  <official_title>Correlation of In-lab Pleural Fluid Glucose Measurements With a Finger Stick Glucometer and Portable Point of Care Testing Device (i-STAT).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oklahoma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oklahoma</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>
      Pleural fluid glucose levels measured with bed-side point of care methods such as finger&#xD;
      stick glucometers and I-STAT device correlate with the traditional in-lab testing methods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective study which will identify patients in VAMC with a diagnosis of pleural&#xD;
      effusion and undergoing diagnostic thoracentesis.The investigators plan to analyze the two&#xD;
      bedside point-of-care fluid glucose testing methods (I- STAT device and finger stick&#xD;
      glucometer) to measure pleural fluid glucose levels. The results obtained from these two&#xD;
      methods will be compared to the traditionally in lab measured pleural fluid glucose levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">August 28, 2019</completion_date>
  <primary_completion_date type="Actual">August 28, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation of pleural fluid glucose measured with a glucometer and the I-STAT with the pleural fluid glucose level measured in the Lab</measure>
    <time_frame>&lt;1 hour</time_frame>
    <description>Primary outcome will be the inter-assay precision of the finger stick glucometer and the I-STAT device as compared to the Gold standard in lab testing of pleural glucose.This will be done using the Bland-Altman plot.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intra assay precision of pleural fluid glucose measured with a glucometer and with an I-STAT device.</measure>
    <time_frame>&lt; 1hour</time_frame>
    <description>assessment of intra assay precision of of 2 measurements of pleural fluid glucose done by the glucometer as well as the ISTAT device .</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Pleural Effusions</condition>
  <arm_group>
    <arm_group_label>iSTAT Study Group</arm_group_label>
    <description>Measure glucose of pleural fluid via glucometer, in the laboratory, and using the iSTAT device to see if the three methods give a similar reading or not.</description>
  </arm_group>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      Pleural fluid&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pleural effusions&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  any patient 18 to 99 year old with a diagnosis of pleural effusion and undergoing a&#xD;
             diagnostic thoracentesis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent by the patient or the surrogate to enroll for&#xD;
             the planned study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Houssein Youness, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>OUHSC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VAMC OKC</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>March 4, 2020</last_update_submitted>
  <last_update_submitted_qc>March 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pleural</keyword>
  <keyword>glucose</keyword>
  <keyword>glucometer</keyword>
  <keyword>i-STAT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pleural Effusion</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Deidentified data may only be shared upon review of OUHSC Legal office and IRB. Data sharing agreement required. Contact research@ouhsc.edu to initiate data requests. No personally identifiable data will be shared.</ipd_description>
  </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/NCT02208895
org study id: 3785
secondary id: VAMC OKC
nct id: NCT02208895
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pleural fluid glucose levels measured with bed-side point of care methods such as finger
      stick glucometers and I-STAT device correlate with the traditional in-lab testing methods.
This is a prospective study which will identify patients in VAMC with a diagnosis of pleural
      effusion and undergoing diagnostic thoracentesis.The investigators plan to analyze the two
      bedside point-of-care fluid glucose testing methods (I- STAT device and finger stick
      glucometer) to measure pleural fluid glucose levels. The results obtained from these two
      methods will be compared to the traditionally in lab measured pleural fluid glucose levels.
observational model: Case-Only
time perspective: Prospective
measure: Correlation of pleural fluid glucose measured with a glucometer and the I-STAT with the pleural fluid glucose level measured in the Lab
time frame: <1 hour
description: Primary outcome will be the inter-assay precision of the finger stick glucometer and the I-STAT device as compared to the Gold standard in lab testing of pleural glucose.This will be done using the Bland-Altman plot.
measure: Intra assay precision of pleural fluid glucose measured with a glucometer and with an I-STAT device.
time frame: < 1hour
description: assessment of intra assay precision of of 2 measurements of pleural fluid glucose done by the glucometer as well as the ISTAT device .
arm group label: iSTAT Study Group
description: Measure glucose of pleural fluid via glucometer, in the laboratory, and using the iSTAT device to see if the three methods give a similar reading or not.
Pleural fluid
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Houssein Youness, MD
role: Principal Investigator
affiliation: OUHSC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pleural Effusion
sharing ipd: No
ipd description: Deidentified data may only be shared upon review of OUHSC Legal office and IRB. Data sharing agreement required. Contact research@ouhsc.edu to initiate data requests. No personally identifiable data will be shared.