A Miniaturized Device to Non-invasively Measure the Oxygenation and Hemoglobin Concentration in the Brain Using Near-infrared Spectroscopy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Standard deviation of repeated StO2 level measurements (precision)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Substudy 1 (healthy adult volunteers)
- •Inclusion Criteria:
- •Healthy adult
- •Signed informed consent
排除标准
- •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
研究组 & 干预措施
precision and accuracy study
precision and accuracy of Oxyprem are studied
干预措施: Measurement of tissue oxygenation with novel diagnostic near-infrared spectroscopy device (OxyPrem) (no clinical decisions based on oxygenation levels) (Device)
结局指标
主要结局
Standard deviation of repeated StO2 level measurements (precision)
时间窗: 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.
次要结局
未报告次要终点
研究者
Hans Ulrich Bucher
Principal Investigator
University of Zurich