iSTAT Comparison Study, IRB3785
Correlation of In-lab Pleural Fluid Glucose Measurements With a Finger Stick Glucometer and Portable Point of Care Testing Device (i-STAT).
2 other identifiers
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 31, 2014
CompletedFirst Posted
Study publicly available on registry
August 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2019
CompletedMarch 6, 2020
March 1, 2020
5.6 years
July 31, 2014
March 4, 2020
Conditions
Keywords
Outcome Measures
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
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.
<1 hour
Secondary Outcomes (1)
Intra assay precision of pleural fluid glucose measured with a glucometer and with an I-STAT device.
< 1hour
Study Arms (1)
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.
Eligibility Criteria
Pleural effusions
You may qualify if:
- any patient 18 to 99 year old with a diagnosis of pleural effusion and undergoing a diagnostic thoracentesis.
You may not qualify if:
- Inability to provide informed consent by the patient or the surrogate to enroll for the planned study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VAMC OKC
Oklahoma City, Oklahoma, 73104, United States
Biospecimen
Pleural fluid
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Houssein Youness, MD
OUHSC
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2014
First Posted
August 5, 2014
Study Start
February 1, 2014
Primary Completion
August 28, 2019
Study Completion
August 28, 2019
Last Updated
March 6, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share
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.