Cerebral Oxygenation Values in Healthy Adults Volunteers Measured With RheoPatch and NIRO-200NX

Comparison of Cerebral Oxygenation Values in Healthy Adults

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)

Study Overview

• Status: Completed
• Conditions: Healthy; Adults
• Intervention / Treatment: Device: Cerebral oximetry using Rheopatch; Device: Cerebral oximetry using NIRO-200NX

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.

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Dep. Anesthesiology and Pain Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebral oxygen saturation level	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.	One day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of the measurements of cerebral oxygenation saturation level (SbtO2 (%) and TOI (%))	SbtO2 and TOI changes are measured	One day
nTHI_NIRO	Normalized tissue hemoglobin index: nTHI (absolute value in arbitrary unit)	One day
ΔO2Hb_NIRO	Oxygenated hemoglobin change: ΔO2Hb (μmol/L)	One day
ΔHHb_NIRO	Deoxygenated hemoglobin change: ΔHHb (μmol/L)	One day
ΔcHb_NIRO	Total hemoglobin change: ΔcHb (μmol/L)	One day
aH2O_RP	Absolute concentration of brain tissue water: aH2O (mmol/L)	One day
aHbDeoxy_RP	Absolute concentration of deoxygenated hemoglobin: aHbDeoxy (μmol/L)	One day
aHbOxy_RP	Absolute concentration of oxygenated hemoglobin: aHbOxy (μmol/L)	One day
aHbTotal_RP	Absolute concentration of total hemoglobin: aHbTotal (μmol/L)	One day
ΔO2Hb_RP	Oxygenated hemoglobin change: ΔO2Hb (μmol/L)	One day
ΔHHb_RP	Deoxygenated hemoglobin change: ΔHHb (μmol/L)	One day
ΔcHb_RP	Total hemoglobin change: ΔcHb (μmol/L)	One day

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Study Chair: Gabor Erdoes, MD PhD, University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): May 10, 2023

Study Registration Dates

• First Submitted: July 5, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2021-D0083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No