Clinical trial NCT05460585: Cerebral Oxygenation Values in Healthy Adults Volunteers Measured With RheoPatch and NIRO-200NX
Official title: Comparison of Cerebral Oxygenation Values in Healthy Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Adults
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The project population consists of volunteers in subjective good health. Volunteers are chosen to minimize the effect of diseases on the measurements, as the investigators are interested in baseline measurement values and repeatability.

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.

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

Primary outcomes:
measure: Cerebral oxygen saturation level
timeFrame: One day
Secondary outcomes:
measure: Changes of the measurements of cerebral oxygenation saturation level (SbtO2 (%) and TOI (%))
timeFrame: One day
measure: nTHI_NIRO
timeFrame: One day
measure: ΔO2Hb_NIRO
timeFrame: One day
measure: ΔHHb_NIRO
timeFrame: One day
measure: ΔcHb_NIRO
timeFrame: One day
measure: aH2O_RP
timeFrame: One day
measure: aHbDeoxy_RP
timeFrame: One day
measure: aHbOxy_RP
timeFrame: One day
measure: aHbTotal_RP
timeFrame: One day
measure: ΔO2Hb_RP
timeFrame: One day
measure: ΔHHb_RP
timeFrame: One day
measure: ΔcHb_RP
timeFrame: One day
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Dep. Anesthesiology and Pain Therapy
Study officials:
affiliation: University of Bern
name: Gabor Erdoes, MD PhD
role: STUDY_CHAIR
References: