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The substudy in premature infants was completed. The substudy in adult volunteers will not be continued, due to previous delays.
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The precision of the novel diagnostic near-infrared spectroscopy (NIRS) device for the measurement of tissue oxygenation and hemoglobin concentration (OxyPrem) is assessed by repeated measurements. The accuracy of OxyPrem is assessed by comparing the measurement data to those acquired simultaneously by established NIRS devices and standard clinical monitoring devices. In substudy 1, healthy adult subjects are enrolled, in substudy 2, measurements are conducted on preterm neonates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| precision and accuracy study | Experimental | precision and accuracy of Oxyprem are studied |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measurement of tissue oxygenation with novel diagnostic near-infrared spectroscopy device (OxyPrem) (no clinical decisions based on oxygenation levels) | Device | The precision of OxyPrem is assessed by repeated measurements of tissue oxygenation and hemoglobin concentration. The accuracy of OxyPrem is assessed by comparing the measurement data to those acquired simultaneously by established NIRS devices and standard clinical monitoring devices. In substudy 1, healthy adult subjects are enrolled, in substudy 2, measurements are conducted on preterm neonates. |
| Measure | Description | Time Frame |
|---|---|---|
| Standard deviation of repeated StO2 level measurements (precision) | The precision of the StO2 measurement is the reproducibility within multiple consecutive measurements under similar conditions, expressed as the standard deviation of repeated measurements. | baseline |
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Substudy 1 (healthy adult volunteers)
Inclusion Criteria:
Exclusion Criteria:
Substudy 2 (preterm infants)
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bucher, Prof.em. | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Zurich | Zurich | Canton of Zurich | 8091 | Switzerland |
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