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| Name | Class |
|---|---|
| Erasme University Hospital | OTHER |
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The study is to demonstrate the accuracy of the OptiScanner in measuring blood glucose levels in critically ill patients when compared to a reference YSI 2300 STAT Plus and the Gem 3000, the reference standard for Erasme University Hospital.
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| Measure | Description | Time Frame |
|---|---|---|
| Glucose Prediction error | Percent (%) predicted error is the percent (%) error result of the OptiScanner on central venous blood from the superior cava versus the YSI and the GEM using arterial blood. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Clarke Error Grid analysis | The Clarke Error Grid analysis shows the percentage of paired values falling within each zone between the glucose results of the OptiScanner on central venous versus the YSI and the GEM using arterial blood. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Critically ill patients admitted to the intensive care unit (ICU) of Erasme University Hospital in Brussels, Belgium.
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Charles Preiser, MD, PhD | Erasme University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasme University Hospital | Brussels | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27884157 | Derived | Righy Shinotsuka C, Brasseur A, Fagnoul D, So T, Vincent JL, Preiser JC. Manual versus Automated moNitoring Accuracy of GlucosE II (MANAGE II). Crit Care. 2016 Nov 25;20(1):380. doi: 10.1186/s13054-016-1547-3. |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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One additional blood sample (4 ml)will be collected once a day, separated into Draw an additional ~ 4.0 mL from the subject into a syringe once per every 24 hour period. The study site will indicate where and at what time the sample was taken. This sample is placed into a sodium heparin tube, labeled with the subject number and sampling time and centrifuged on a refrigerated centrifuge. The gained plasma will be frozen at minus 70 degrees Celsius or less and may be used for potential analysis by the Sponsor, should an analysis of outliers indicate the potential presence of an interferent.