Comparison of Cerebral Oxygenation Values in Healthy Adults
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Insel Gruppe AG, University Hospital Bern
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Cerebral oxygen saturation level
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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)
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects fulfilling all of the following inclusion criteria are eligible for the investigation:
- •Informed Consent signed by the subject
- •Subjective good health
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Cerebral oxygen saturation level
Time Frame: 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.
Secondary Outcomes
- 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)