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iSTAT Comparison Study, IRB3785

Sponsor
University of Oklahoma (Other)
Overall Status
Completed
CT.gov ID
NCT02208895
Collaborator
(none)
60
Enrollment
1
Location
66.8
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    60 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Correlation of In-lab Pleural Fluid Glucose Measurements With a Finger Stick Glucometer and Portable Point of Care Testing Device (i-STAT).
    Study Start Date :
    Feb 1, 2014
    Actual Primary Completion Date :
    Aug 28, 2019
    Actual Study Completion Date :
    Aug 28, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    iSTAT Study Group

    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.

    Outcome Measures

    Primary Outcome Measures

    1. Correlation of pleural fluid glucose measured with a glucometer and the I-STAT with the pleural fluid glucose level measured in the Lab [<1 hour]

      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.

    Secondary Outcome Measures

    1. Intra assay precision of pleural fluid glucose measured with a glucometer and with an I-STAT device. [< 1hour]

      assessment of intra assay precision of of 2 measurements of pleural fluid glucose done by the glucometer as well as the ISTAT device .

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • any patient 18 to 99 year old with a diagnosis of pleural effusion and undergoing a diagnostic thoracentesis.
    Exclusion Criteria:
    • Inability to provide informed consent by the patient or the surrogate to enroll for the planned study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 VAMC OKC Oklahoma City Oklahoma United States 73104

    Sponsors and Collaborators

    • University of Oklahoma

    Investigators

    • Principal Investigator: Houssein Youness, MD, OUHSC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Oklahoma
    ClinicalTrials.gov Identifier:
    NCT02208895
    Other Study ID Numbers:
    • 3785
    • VAMC OKC
    First Posted:
    Aug 5, 2014
    Last Update Posted:
    Mar 6, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Oklahoma
    pleural
    glucose
    glucometer
    i-STAT
    Additional relevant MeSH terms:
    Pleural Effusion

    Study Results

    No Results Posted as of Mar 6, 2020