A Miniaturized Device to Non-invasively Measure the Oxygenation and Hemoglobin Concentration in the Brain Using Near-infrared Spectroscopy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tissue Oxygenation Measurement
- Sponsor
- Hans Ulrich Bucher
- Enrollment
- 117
- Locations
- 1
- Primary Endpoint
- Standard deviation of repeated StO2 level measurements (precision)
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Hans Ulrich Bucher
Principal Investigator
University of Zurich
Eligibility Criteria
Inclusion Criteria
- •Healthy adult
- •Signed informed consent
Exclusion Criteria
- •Dense black hair at the location of measurement
- •Neurological diseases.
- •Substudy 2 (preterm infants)
- •Inclusion Criteria:
- •Pre-term neonates (gestational age at birth less than 37 weeks)
- •Signed informed consent by at least one parent
- •Exclusion Criteria:
- •Clinically instability
- •Malformations
Outcomes
Primary Outcomes
Standard deviation of repeated StO2 level measurements (precision)
Time Frame: baseline
The precision of the StO2 measurement is the reproducibility within multiple consecutive measurements under similar conditions, expressed as the standard deviation of repeated measurements.