Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2025-12-27 @ 9:24 PM
Study NCT ID:
NCT02208895
Status:
COMPLETED
Last Update Posted:
2020-03-06
First Post:
2014-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iSTAT Comparison Study, IRB3785
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010996', 'term': 'Pleural Effusion'}], 'ancestors': [{'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Pleural fluid'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-04', 'studyFirstSubmitDate': '2014-07-31', 'studyFirstSubmitQcDate': '2014-08-01', 'lastUpdatePostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of pleural fluid glucose measured with a glucometer and the I-STAT with the pleural fluid glucose level measured in the Lab', 'timeFrame': '<1 hour', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Intra assay precision of pleural fluid glucose measured with a glucometer and with an I-STAT device.', 'timeFrame': '< 1hour', 'description': 'assessment of intra assay precision of of 2 measurements of pleural fluid glucose done by the glucometer as well as the ISTAT device .'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pleural', 'glucose', 'glucometer', 'i-STAT'], 'conditions': ['Pleural Effusions']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pleural effusions', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any patient 18 to 99 year old with a diagnosis of pleural effusion and undergoing a diagnostic thoracentesis.\n\nExclusion Criteria:\n\n* Inability to provide informed consent by the patient or the surrogate to enroll for the planned study.'}, 'identificationModule': {'nctId': 'NCT02208895', 'briefTitle': 'iSTAT Comparison Study, IRB3785', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Correlation of In-lab Pleural Fluid Glucose Measurements With a Finger Stick Glucometer and Portable Point of Care Testing Device (i-STAT).', 'orgStudyIdInfo': {'id': '3785'}, 'secondaryIdInfos': [{'id': 'VAMC OKC', 'type': 'OTHER', 'domain': 'VAMC OKC'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'iSTAT Study Group', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'VAMC OKC', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Houssein Youness, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OUHSC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}