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

Healthy Clinical Trial

Official title:

Comparison of Cerebral Oxygenation Values in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05460585
• Other study ID #: 2021-D0083
• Status: Completed
• Start date: June 1, 2022
• Est. completion date: May 10, 2023

Study information

• Verified date: May 2023
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 10, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Adults
• Healthy

Intervention

Device:
• Cerebral oximetry using Rheopatch
On the study visit, baseline demographic data (age and gender, BMI) are collected. In supine position the sensor patches (left and right) of the device are applied to the forehead and the cerebral oxymetry values are recorded during 120sec. The sensor patches are then removed and the patches of the second device are applied on the same position on the forehead and the measurement is carried out as described before. For the first measurement of each sensor, a total of 5 minutes equilibration and sensor output power adjustment is allowed. A total of 10 measurements are taken, 5 with each device. The volunteer is then placed in Trendelenburg position and another 4 measurements are made (2 with each device) as previously described.
• Cerebral oximetry using NIRO-200NX
On the study visit, baseline demographic data (age and gender, BMI) are collected. In supine position the sensor patches (left and right) of the device are applied to the forehead and the cerebral oxymetry values are recorded during 120sec. The sensor patches are then removed and the patches of the second device are applied on the same position on the forehead and the measurement is carried out as described before. For the first measurement of each sensor, a total of 5 minutes equilibration and sensor output power adjustment is allowed. A total of 10 measurements are taken, 5 with each device. The volunteer is then placed in Trendelenburg position and another 4 measurements are made (2 with each device) as previously described.

Locations

Country	Name	City	State
Switzerland	Dep. Anesthesiology and Pain Therapy	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes of the measurements of cerebral oxygenation saturation level (SbtO2 (%) and TOI (%))	SbtO2 and TOI changes are measured	One day
Secondary	nTHI_NIRO	Normalized tissue hemoglobin index: nTHI (absolute value in arbitrary unit)	One day
Secondary	?O2Hb_NIRO	Oxygenated hemoglobin change: ?O2Hb (µmol/L)	One day
Secondary	?HHb_NIRO	Deoxygenated hemoglobin change: ?HHb (µmol/L)	One day
Secondary	?cHb_NIRO	Total hemoglobin change: ?cHb (µmol/L)	One day
Secondary	aH2O_RP	Absolute concentration of brain tissue water: aH2O (mmol/L)	One day
Secondary	aHbDeoxy_RP	Absolute concentration of deoxygenated hemoglobin: aHbDeoxy (µmol/L)	One day
Secondary	aHbOxy_RP	Absolute concentration of oxygenated hemoglobin: aHbOxy (µmol/L)	One day
Secondary	aHbTotal_RP	Absolute concentration of total hemoglobin: aHbTotal (µmol/L)	One day
Secondary	?O2Hb_RP	Oxygenated hemoglobin change: ?O2Hb (µmol/L)	One day
Secondary	?HHb_RP	Deoxygenated hemoglobin change: ?HHb (µmol/L)	One day
Secondary	?cHb_RP	Total hemoglobin change: ?cHb (µmol/L)	One day