iSTAT Comparison Study, IRB3785
- Conditions
- Pleural Effusions
- Registration Number
- NCT02208895
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- any patient 18 to 99 year old with a diagnosis of pleural effusion and undergoing a diagnostic thoracentesis.
- Inability to provide informed consent by the patient or the surrogate to enroll for the planned study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 .
Trial Locations
- Locations (1)
VAMC OKC
🇺🇸Oklahoma City, Oklahoma, United States