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

Sponsor

University Hospital Inselspital, Berne (Other)

Overall Status

Recruiting

CT.gov ID

NCT05460585

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Healthy Adults	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 Design

Study Type:

Observational

Anticipated Enrollment :

15 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Comparison of Cerebral Oxygenation Values in Healthy Adults

Actual Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dep. Anesthesiology and Pain Therapy	Bern		Switzerland	3010

Sponsors and Collaborators

University Hospital Inselspital, Berne

Investigators

Study Chair: Gabor Erdoes, MD PhD, University of Bern

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital Inselspital, Berne

ClinicalTrials.gov Identifier:

NCT05460585

Other Study ID Numbers:

2021-D0083

First Posted:

Jul 15, 2022

Last Update Posted:

Jul 15, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Jul 15, 2022