Geen speciale klasse, patienten met en zonder diabetes diabetes
Conditions
Interventions
None listed
Sponsors
Roche Diagnostics GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adult Signed informed consent (before admittance to the ICU after scheduled operation). Diabetic and non-diabetic
Exclusion criteria
Exclusion criteria: Minor (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary research parameter is the blood glucose concentration. In the second phase of this study the accuracy of measurement of the ACI 3 will be determined. In the main phase, the performance of the ACI 3 on patient material is compared to the reference method. The results of this study will not be used for for regulatory submission or approval. If study results are deemed acceptable internally, a subsequent full performance evaluation study will take place. | — |
Secondary
| Measure | Time frame |
|---|---|
| In order to detect and explain possible interference, the percentage of hematocrit is also determined per patient (from material of the same sample). As additional information, the use of medication and, if determined, the diagnosis of 'diabetes' is also included. The sodium concentration and measured partial oxygen pressure (pO2) are only provided if a blood gas is routinely requested. | — |
Countries
Netherlands
Outcome results
None listed