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).

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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • VAMC OKC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pleural effusions

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra assay precision of pleural fluid glucose measured with a glucometer and with an I-STAT device.	assessment of intra assay precision of of 2 measurements of pleural fluid glucose done by the glucometer as well as the ISTAT device .	< 1hour

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Houssein Youness, MD, OUHSC

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): August 28, 2019
• Study Completion (Actual): August 28, 2019

Study Registration Dates

• First Submitted: July 31, 2014
• First Submitted That Met QC Criteria: August 1, 2014
• First Posted (Estimate): August 5, 2014

Study Record Updates

• Last Update Posted (Actual): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: glucose; i-STAT; glucometer; pleural
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: 3785; VAMC OKC (Other Identifier: VAMC OKC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No