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Correlation of In-lab Pleural Fluid Glucose Measurements With a Finger Stick Glucometer and Portable Point of Care Testing Device (i-STAT).

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ClinicalTrials.gov Identifier: NCT02208895
Recruitment Status : Active, not recruiting
First Posted : August 5, 2014
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Houssein Youness, University of Oklahoma

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
Pleural Effusions

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 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 : February 2014
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

Group/Cohort
Glucometer
Measure glucose of pleural fluid via glucometer
in lab
Measure pleural fluid glucose in lab
i-STAT
measure pleural fluid glucose via i-STAT



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 [ Time Frame: <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. [ Time Frame: < 1hour ]
    assessment of intra assay precision of of 2 measurements of pleural fluid glucose done by the glucometer as well as the ISTAT device .


Biospecimen Retention:   None Retained
Pleural fluid


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pleural effusions
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02208895


Locations
United States, Oklahoma
VAMC OKC
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Houssein Youness, MD OUHSC

Responsible Party: Houssein Youness, MD, University of Oklahoma
ClinicalTrials.gov Identifier: NCT02208895     History of Changes
Other Study ID Numbers: 3785
VAMC OKC ( Other Identifier: VAMC OKC )
First Posted: August 5, 2014    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018

Keywords provided by Houssein Youness, University of Oklahoma:
pleural
glucose
glucometer
i-STAT

Additional relevant MeSH terms:
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases