Pleural EffusionsNCT02208895
iSTAT Comparison Study, IRB3785
An observational study of Pleural Effusions, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pleural Effusions
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 28 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pleural effusions
Who may be able to join
- any patient 18 to 99 year old with a diagnosis of pleural effusion and undergoing a diagnostic thoracentesis.
Who cannot join
- Inability to provide informed consent by the patient or the surrogate to enroll for the planned study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pleural Effusions
- Keywords
- pleural, glucose, glucometer, i-STAT
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: <1 hour
Secondary outcomes (1)
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 .
Measured: < 1hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startFeb 2014
- Primary completion28 Aug 2019
- Study completion28 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Houssein Youness, MD, Principal investigator, OUHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208895
- Sponsor's protocol ID
- 3785
- Other IDs
- VAMC OKC
- Status last verified
- Mar 2020
- First submitted
- 31 Jul 2014
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of In-lab Pleural Fluid Glucose Measurements With a Finger Stick Glucometer and Portable Point of Care Testing Device (i-STAT).
- ClinicalTrials.gov ID
- NCT02208895
- Acronym / sponsor ID
- 3785
- Conditions
- Pleural Effusions
- Keywords
- pleural, glucose, glucometer, i-STAT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- 28 Aug 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 5 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pleural effusions
Key inclusion criteria (1 listed)
- any patient 18 to 99 year old with a diagnosis of pleural effusion and undergoing a diagnostic thoracentesis.
Key exclusion criteria (1 listed)
- Inability to provide informed consent by the patient or the surrogate to enroll for the planned study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Intra assay precision of pleural fluid glucose measured with a glucometer and with an I-STAT device.
Time frame: < 1hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Individual participant dataSharing planned: No. 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.
Related trials for Pleural Effusions
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Union-LC-MPE Cohort:A Multicenter Cohort Study on Diagnosis and Prognosis of Malignant Pleural Effusion in Lung Cance
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Houssein Youness, MD principal investigator
OUHSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Effusions, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.