Comparison of Cerebral Oxygenation Values in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Cerebral oxygen saturation level
研究概览
简要总结
Noninvasive measurement of cerebral tissue oxygen saturation levels by near infrared spectroscopy (NIRS) is clinical routine in perioperative medicine. One of the main technical challenges of NIRS measurements is to eliminate the influence of signals of the skin and skull. A new device (RheoPatch, Luciole Medical AG, Zurich) has been developed by a company that also developed an intracranial NIRS probe, which allowed measurements directly in the brain and thus improved algorithms for elimination of the extracranial signals. The investigators aim to determine baseline values and performance of the new device (RheoPatch) compared with a more established NIRS device (NIRO-200NX, Hamamatsu Phototonics, Hamamatsu City, Japan)
详细描述
Primary objective is to compare the RheoPatch NIRS device with the NIRO-200NX NIRS device in volunteers at rest in supine position. As secondary objectives, repeatability of the measurements will be tested with optode reapplications. With measurements in Trendelenburg position, the investigators evaluate the influence of body (head) position on the NIRS signals.
Primary outcome are the baseline values of cerebral oxygenation levels measured by RheoPatch (SbtO2 (%)) and NIRO-200NX (Tissue oxygenation index: TOI (%)).
Secondary endpoints are the repeatability of the measurements with sensor reapplications (coefficient of repeatability, 5 repeats with each device) and changes of the measurements of cerebral oxygenation saturation level in the Trendelenburg position.
Measurements of baseline cerebral oxygenation values are obtained in supine position with 10 measurements, alternating between devices. Combined with 5 min measurement phase for equilibration and power adjustment, this will require 33 minutes per participant.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects fulfilling all of the following inclusion criteria are eligible for the investigation:
- •Informed Consent signed by the subject
- •Subjective good health
排除标准
- •The presence of any one of the following exclusion criteria will lead to the exclusion of the subject
- •Age (<18, > 65 yrs.)
- •Forehead skin disease
- •Allergy to skin contacting components of NIRS-sensors
- •Known cerebrovascular and heart diseases
结局指标
主要结局
Cerebral oxygen saturation level
时间窗: One day
Primary endpoint is the cerebral oxygen saturation level measured by RheoPatch (SbtO2 (%)) and NIRO-200NX (Tissue oxygenation index: TOI (%)). This is the value used for clinical decision making in the daily routine when NIRS measurement devices are used in perioperative medicine or intensive care applications and therefore the most relevant value.
次要结局
- ΔO2Hb_NIRO(One day)
- ΔHHb_NIRO(One day)
- aHbTotal_RP(One day)
- ΔHHb_RP(One day)
- Changes of the measurements of cerebral oxygenation saturation level (SbtO2 (%) and TOI (%))(One day)
- ΔcHb_NIRO(One day)
- aH2O_RP(One day)
- aHbOxy_RP(One day)
- nTHI_NIRO(One day)
- aHbDeoxy_RP(One day)
- ΔO2Hb_RP(One day)
- ΔcHb_RP(One day)