iSTAT Comparison Study, IRB3785

NCT ID: NCT02208895

Last Updated: 2020-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2019-08-28

Brief Summary

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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

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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.

Conditions

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Pleural Effusions

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Houssein Youness, MD

Role: PRINCIPAL_INVESTIGATOR

OUHSC

Locations

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VAMC OKC

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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VAMC OKC

Identifier Type: OTHER

Identifier Source: secondary_id

3785

Identifier Type: -

Identifier Source: org_study_id

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