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

Completed

• Conditions: Adults; Healthy

• Registration Number: NCT05460585
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-07-05
• Study First Submitted QC: 2022-07-11
• Study First Posted: 2022-07-15
• Primary Completion: 2023-03-01
• Status Verified: 2023-05
• Study Completion: 2023-05-10
• Last Update Submitted: 2023-05-12
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cerebral oxygen saturation level	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 Outcome Measures

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

Trial Locations

Locations (1)

Dep. Anesthesiology and Pain Therapy; 🇨🇭 Bern, Switzerland