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Completed

NCT Number: NCT02208895

iSTAT Comparison Study, IRB3785

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.

Completed

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Key information

Conditions

Pleural Effusions Pleural Diseases Pleural Effusion Respiratory Tract Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

VAMC OKC

Oklahoma City, Oklahoma, 73104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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 .

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Aug 5, 2014
Registry last updated
Mar 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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